A Phase 3 Trial of Brentuximab Vedotin(SGN-35) Versus Physician's Choice (Methotrexate or Bexarotene) in Participants With CD30-Positive Cutaneous T-Cell Lymphoma (ALCANZA Study) (ALCANZA)

• ClinicalTrials.gov Identifier: NCT01578499
• Recruitment Status: Completed
• First Posted: April 17, 2012
• Results First Posted: March 16, 2018
• Last Update Posted: January 5, 2021
• Sponsor: Millennium Pharmaceuticals, Inc.
• Collaborator: Seagen Inc.
• Information provided by (Responsible Party): Takeda ( Millennium Pharmaceuticals, Inc. )

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Conditions: Primary Cutaneous Anaplastic Large Cell Lymphoma; Mycosis Fungoides; Cutaneous T-Cell Lymphoma
• Interventions: Drug: Brentuximab Vedotin; Drug: Methotrexate; Drug: Bexarotene
• Enrollment: 131

Participant Flow

Recruitment Details	Participants took part in the study at 34 investigative sites in Australia, Belgium, Brazil, France, Germany, Italy, Poland, Spain, Switzerland, United Kingdom, United States from 11 June 2012 to the Primary Completion data of 06 July 2018.
Pre-assignment Details	Participants with a diagnosis of cluster of differentiation antigen 30 (CD30)-Positive Cutaneous T-Cell Lymphoma were enrolled equally in 1 of 2 arms: brentuximab vedotin 1.8 mg/kg or physician's choice (Methotrexate or Bexarotene).

Arm/Group Title	Brentuximab Vedotin	Methotrexate or Bexarotene
Arm/Group Description	Brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).	Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m^2, tablets, orally, once daily with meals for up to 48 weeks.
Period Title: Overall Study
Started	66	65
Safety Population: Treated	66	62
Intent to Treat Population: CD30+	64	64
Completed	32	22
Not Completed	34	43
Reason Not Completed
Reason not Specified	0	1
Lost to Follow-up	2	1
Withdrawal by Subject	10	16
Death	20	25
Died and End of Study Page not Completed	2	0

Baseline Characteristics

Arm/Group Title		Brentuximab Vedotin	Methotrexate or Bexarotene	Total
Arm/Group Description		Brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).	Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m^2, tablets, orally, once daily with meals for up to 48 weeks.	Total of all reporting groups
Overall Number of Baseline Participants		66	64	130
Baseline Analysis Population Description		Safety population included participants who received at least 1 dose of study drug, analyzed according to the actual treatment received (n=66,62). Intent-to-treat population (ITT) population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment (n=64,64).
Age, Continuous [1]; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	66 participants	62 participants	128 participants
		59.4 (13.80)	56.6 (14.43)	58.0 (14.12)
		[1] Measure Analysis Population Description: Safety population included participants who received at least 1 dose of study drug, analyzed according to the actual treatment received.
Sex: Female, Male [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	66 participants	62 participants	128 participants
	Female	33 50.0%	28 45.2%	61 47.7%
	Male	33 50.0%	34 54.8%	67 52.3%
		[1] Measure Analysis Population Description: Safety population included participants who received at least 1 dose of study drug, analyzed according to the actual treatment received.
Race/Ethnicity, Customized [1]; Measure Type: Number; Unit of measure: Participants
White	Number Analyzed	64 participants	64 participants	128 participants
		56	53	109
Black or African American	Number Analyzed	64 participants	64 participants	128 participants
		3	3	6
Asian	Number Analyzed	64 participants	64 participants	128 participants
		1	5	6
Not reported	Number Analyzed	64 participants	64 participants	128 participants
		3	1	4
Other	Number Analyzed	64 participants	64 participants	128 participants
		1	2	3
		[1] Measure Analysis Population Description: ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment.
Race/Ethnicity, Customized [1]; Measure Type: Number; Unit of measure: Participants
Hispanic or Latino	Number Analyzed	64 participants	64 participants	128 participants
		2	6	8
Not Hispanic or Latino	Number Analyzed	64 participants	64 participants	128 participants
		60	50	110
Not reported	Number Analyzed	64 participants	64 participants	128 participants
		2	8	10
		[1] Measure Analysis Population Description: ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment.
Region of Enrollment [1]; Measure Type: Count of Participants; Unit of measure: Participants
Australia	Number Analyzed	66 participants	62 participants	128 participants
		12 18.2%	8 12.9%	20 15.6%
Belgium	Number Analyzed	66 participants	62 participants	128 participants
		4 6.1%	2 3.2%	6 4.7%
France	Number Analyzed	66 participants	62 participants	128 participants
		4 6.1%	3 4.8%	7 5.5%
Germany	Number Analyzed	66 participants	62 participants	128 participants
		3 4.5%	2 3.2%	5 3.9%
Italy	Number Analyzed	66 participants	62 participants	128 participants
		12 18.2%	6 9.7%	18 14.1%
Poland	Number Analyzed	66 participants	62 participants	128 participants
		2 3.0%	1 1.6%	3 2.3%
Spain	Number Analyzed	66 participants	62 participants	128 participants
		2 3.0%	3 4.8%	5 3.9%
Switzerland	Number Analyzed	66 participants	62 participants	128 participants
		3 4.5%	3 4.8%	6 4.7%
United Kingdom	Number Analyzed	66 participants	62 participants	128 participants
		8 12.1%	15 24.2%	23 18.0%
United States	Number Analyzed	66 participants	62 participants	128 participants
		14 21.2%	17 27.4%	31 24.2%
Brazil	Number Analyzed	66 participants	62 participants	128 participants
		2 3.0%	2 3.2%	4 3.1%
		[1] Measure Analysis Population Description: Safety population included participants who received at least 1 dose of study drug, analyzed according to the actual treatment received.

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Achieving an Objective Response That Lasts at Least 4 Months (ORR4)
Description	ORR4 was determined by an Independent Review Facility (IRF) based on Global Response Score (GRS) which consisted of a skin assessment by the investigator using the modified severity-weighted assessment tool (mSWAT), nodal and visceral radiographic assessment by an IRF and for the participants with mycosis fungoides (MF) only, detection of circulation Sezary cells. Participants whose first response occurred after the start of subsequent anticancer therapy were excluded. Response Criteria was based on International Society for Cutaneous Lymphomas (ISCL), United States Cutaneous Lymphoma Consortium (USCLC) and Cutaneous Lymphoma Task Force (CLTF) of the European Organisation for Research and Treatment of Cancer (EORTC) Consensus guidelines (Olsen, 2011).
Time Frame	Each Cycle until disease progression, death End of treatment (Median overall follow-up 38.8 months)

Outcome Measure Data

Analysis Population Description

The ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment.

Arm/Group Title	Brentuximab Vedotin	Methotrexate or Bexarotene
Arm/Group Description:	Brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).	Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m^2, tablets, orally, once daily with meals for up to 48 weeks.
Overall Number of Participants Analyzed	64	64
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	54.7; (42.5 to 66.9)	12.5; (4.4 to 20.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Brentuximab Vedotin, Methotrexate or Bexarotene
	Comments	Based on a two-sided Χ² test with a significance level of 0.05, and a 10% dropout rate, a sample size of approximately 124 participants was calculated to provide 90% power to detect a 30% improvement in ORR4 in the brentuximab vedotin group.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was stratified by baseline disease diagnosis (pcALCL and MF).
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	42.2
	Confidence Interval	(2-Sided) 95%; 27.5 to 56.8
	Estimation Comments	[Not Specified]

2. Secondary Outcome

Title	Percentage of Participants Achieving a CR
Description	Complete Response (CR) was determined by the IRF based on Global Response Score (GRS) which consisted of a skin assessment by the investigator using the modified severity-weighted assessment tool (mSWAT), nodal and visceral radiographic and for the participants with mycosis fungoides (MF) only, detection of circulation Sezary cells. Response Criteria was based on ISCL, USCLC and CLTF of the EORTC Consensus guidelines (Olsen, 2011).
Time Frame	Each Cycle until disease progression, death or data cutoff (Median overall follow-up 38.8 months)

Outcome Measure Data

Analysis Population Description

The ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment.

Arm/Group Title	Brentuximab Vedotin	Methotrexate or Bexarotene
Arm/Group Description:	Brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).	Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m^2, tablets, orally, once daily with meals for up to 48 weeks.
Overall Number of Participants Analyzed	64	64
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	17.2; (7.9 to 26.4)	1.6; (0.0 to 8.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Brentuximab Vedotin, Methotrexate or Bexarotene
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0002
	Comments	P-value was stratified by baseline disease diagnosis (pcALCL and MF).
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	15.6
	Confidence Interval	(2-Sided) 95%; -2.5 to 33.0
	Estimation Comments	[Not Specified]

3. Secondary Outcome

Title	Progression-Free Survival (PFS)
Description	PFS was assessed by the IRF and is defined as the time from randomization until disease progression or death due to any cause, whichever occurs first. Disease progression was based on ISCL, USCLC and CLTF of the EORTC Consensus guidelines (Olsen, 2011).
Time Frame	Until disease progression, death or data cutoff (Median PFS follow-up of 38.8 months)

Outcome Measure Data

Analysis Population Description

The ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment.

Arm/Group Title	Brentuximab Vedotin	Methotrexate or Bexarotene
Arm/Group Description:	Brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).	Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m^2, tablets, orally, once daily with meals for up to 48 weeks.
Overall Number of Participants Analyzed	64	64
Median (95% Confidence Interval); Unit of Measure: months
	16.7; (15.4 to 21.6)	3.5; (2.4 to 4.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Brentuximab Vedotin, Methotrexate or Bexarotene
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.378
	Confidence Interval	(2-Sided) 95%; 0.247 to 0.577
	Estimation Comments	[Not Specified]
Other Statistical Analysis		Hazard ratio brentuximab vedotin/ comparator (methotrexate or bexarotene) with the 95% CI from a stratified Cox regression model with treatment as the explanatory variable and baseline disease diagnosis (MF or pcALCL) as stratification factor.

4. Secondary Outcome

Title	Maximum Change From Baseline in Symptom Domain Score of the Skindex-29 Questionnaire
Description	Skindex-29 is a 29-item dermatology-specific health-related quality of life (HRQoL). The Skindex-29 incorporates a 28-day recall period and consists of 3 domains: symptoms, emotions, and functioning. The domain scores and an overall score are expressed on a 100-point scale, from 0 to 100 with higher scores indicating lower levels of health- HRQoL. A negative change (reduction) from Baseline indicates improvement.
Time Frame	Baseline up to End of Treatment (Week 52)

Outcome Measure Data

Analysis Population Description

The ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment. Here number of participants analyzed are participants evaluable for this outcome measure.

Arm/Group Title	Brentuximab Vedotin	Methotrexate or Bexarotene
Arm/Group Description:	Brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).	Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m^2, tablets, orally, once daily with meals for up to 48 weeks.
Overall Number of Participants Analyzed	58	54
Mean (Standard Deviation); Unit of Measure: score on a scale
	-28.08 (26.863)	-8.62 (17.013)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Brentuximab Vedotin, Methotrexate or Bexarotene
	Comments	P-value is calculated using the analysis of covariance (ANCOVA) model controlling for baseline symptom domain score, eastern cooperative oncology group (ECOG) performance status score (=0 and ≥1), and disease diagnosis (pcALCL and MF) between the brentuximab vedotin and comparator (methotrexate or bexarotene) arms.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Estimate of difference
	Estimated Value	-19.0
	Confidence Interval	(2-Sided) 95%; -26.7 to -11.4
	Estimation Comments	[Not Specified]

5. Secondary Outcome

Title	Duration of Response (DOR)
Description	Duration of response was assessed by the IRF in participants with confirmed response [CR or Partial Response (PR)] and is defined as the time between first documentation of response and disease progression. Response Criteria was based on ISCL, USCLC and CLTF of the EORTC Consensus guidelines (Olsen, 2011).
Time Frame	Until disease progression, death or data cutoff (Median follow-up 38.8 months)

Outcome Measure Data

Analysis Population Description

The ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment. Responders in ITT population were analyzed in this outcome measure.

Arm/Group Title	Brentuximab Vedotin	Methotrexate or Bexarotene
Arm/Group Description:	Brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).	Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m^2, tablets, orally, once daily with meals for up to 48 weeks.
Overall Number of Participants Analyzed	42	13
Median (95% Confidence Interval); Unit of Measure: months
	15.1; (9.8 to 25.5)	18.4 [1]; (3.5 to NA)

[1]

Upper limit of Confidence Interval (CI) was not estimable due to low number of participants with events.

6. Secondary Outcome

Title	DOR of Skin Response
Description	Duration of skin response (CR and PR) was assessed by the investigator and is defined as the time between the first skin response to progressive disease in skin. Per mSWAT, CR is defined as 100% clearance of skin lesions. PR is defined as 50%-99% clearance of skin disease from Baseline; No new tumors in participants without tumors at Baseline -MF; No new tumors-primary cutaneous anaplastic large cell lymphoma (pcALCL).Progressive disease is defined as ≥ 25% increase in skin disease from baseline, or loss of response: in those with CR or PR, increase of skin score of greater than the sum of nadir plus 50% baseline score, or new tumors in participants without tumors at baseline (MF).
Time Frame	Until disease progression, death or data cutoff (Median follow-up 38.8 months)

Outcome Measure Data

Analysis Population Description

The ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment. Skin responders in ITT population were analyzed in this outcome measure.

Arm/Group Title	Brentuximab Vedotin	Methotrexate or Bexarotene
Arm/Group Description:	Brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).	Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m^2, tablets, orally, once daily with meals for up to 48 weeks.
Overall Number of Participants Analyzed	47	19
Median (95% Confidence Interval); Unit of Measure: months
	18.9; (15.0 to 25.7)	18.3 [1]; (3.5 to NA)

[1]

Upper limit of Confidence Interval (CI) was not estimable due to low number of participants with events.

7. Secondary Outcome

Title	Event-Free Survival (EFS)
Description	EFS was assessed by the IRF and is defined as the time from randomization until any cause of treatment failure: disease progression, discontinuation of treatment for any reason, or death due to any cause, whichever occurs first. Disease progression was based on ISCL, USCLC and CLTF of the EORTC Consensus guidelines (Olsen, 2011).
Time Frame	From randomization until disease progression, death or data cutoff (Median follow-up 36.8 months)

Outcome Measure Data

Analysis Population Description

The ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment.

Arm/Group Title	Brentuximab Vedotin	Methotrexate or Bexarotene
Arm/Group Description:	Brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).	Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m^2, tablets, orally, once daily with meals for up to 48 weeks.
Overall Number of Participants Analyzed	64	64
Median (95% Confidence Interval); Unit of Measure: months
	9.4; (5.9 to 11.7)	2.3; (1.7 to 3.5)

8. Secondary Outcome

Title	Cmax: Maximum Observed Concentration for Brentuximab Vedotin
Description	[Not Specified]
Time Frame	Day 1 pre-dose and 30 minutes after infusion in Cycles 1 and 3

Outcome Measure Data

Analysis Population Description

The pharmacokinetic (PK) population included participants with sufficient dose and PK data to reliably estimate PK parameters as determined by a clinical pharmacologist. Here 'Number analyzed' is the number of participants with evaluable data at the specified time-point.

Arm/Group Title		pcALCL: Brentuximab Vedotin	MF: Brentuximab Vedotin 1.8 mg/kg
Arm/Group Description:		Participants with primary cutaneous anaplastic large cell lymphoma (pcALCL) received brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).	Participants with mycosis fungoides (MF) received brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
Overall Number of Participants Analyzed		16	50
Mean (Standard Deviation); Unit of Measure: ug/mL
Cycle 1 Day 1	Number Analyzed	15 participants	50 participants
		38.36 (9.427)	38.40 (8.912)
Cycle 3 Day 1	Number Analyzed	12 participants	41 participants
		40.14 (12.697)	36.69 (14.249)

9. Secondary Outcome

Title	Ctrough: Observed Concentration at the End of a Dosing Interval for Brentuximab Vedotin
Description	[Not Specified]
Time Frame	Day 1 pre-dose of Cycles 2 and 4

Outcome Measure Data

Analysis Population Description

The PK population included participants with sufficient dose and PK data to reliably estimate PK parameters as determined by a clinical pharmacologist. Here 'Number analyzed' is the number of participants with evaluable data at the specified time-point.

Arm/Group Title		pcALCL: Brentuximab Vedotin	MF: Brentuximab Vedotin 1.8 mg/kg
Arm/Group Description:		Participants with pcALCL received brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).	Participants with MF received brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
Overall Number of Participants Analyzed		16	50
Mean (Standard Deviation); Unit of Measure: ug/mL
Cycle 2 Day 1	Number Analyzed	11 participants	31 participants
		3.57 (10.101)	0.58 (0.517)
Cycle 4 Day 1	Number Analyzed	8 participants	28 participants
		0.99 (0.528)	0.78 (0.446)

10. Secondary Outcome

Title	Cmax: Maximum Observed Concentration for Monomethyl Auristatin (MMAE) for Brentuximab Vedotin
Description	[Not Specified]
Time Frame	Day 1 pre-dose and 30 minutes after infusion ended in Cycles 1 and 3

Outcome Measure Data

Analysis Population Description

The PK population included participants with sufficient dose and PK data to reliably estimate PK parameters as determined by a clinical pharmacologist. Here 'Number analyzed' is the number of participants with evaluable data at the specified time-point.

Arm/Group Title		pcALCL: Brentuximab Vedotin	MF: Brentuximab Vedotin 1.8 mg/kg
Arm/Group Description:		Participants with pcALCL received brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).	Participants with MF received brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
Overall Number of Participants Analyzed		16	50
Mean (Standard Deviation); Unit of Measure: ng/mL
Cycle 1 Day 1	Number Analyzed	13 participants	46 participants
		2.53 (1.382)	3.34 (1.901)
Cycle 3 Day 1	Number Analyzed	12 participants	36 participants
		2.96 (1.176)	3.08 (1.276)

11. Secondary Outcome

Title	Ctrough: Observed Concentration at the End of a Dosing Interval for MMAE for Brentuximab Vedotin
Description	[Not Specified]
Time Frame	Day 1 pre-dose of Cycles 2 and 4

Outcome Measure Data

Analysis Population Description

The PK population included participants with sufficient dose and PK data to reliably estimate PK parameters as determined by a clinical pharmacologist. Here 'Number analyzed' is the number of participants with evaluable data at the specified time-point.

Arm/Group Title		pcALCL: Brentuximab Vedotin	MF: Brentuximab Vedotin 1.8 mg/kg
Arm/Group Description:		Participants with pcALCL received brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).	Participants with MF received brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
Overall Number of Participants Analyzed		16	50
Mean (Standard Deviation); Unit of Measure: ng/mL
Cycle 2 Day 1	Number Analyzed	11 participants	33 participants
		0.11 (0.095)	0.09 (0.060)
Cycle 4 Day 1	Number Analyzed	10 participants	34 participants
		0.14 (0.113)	0.11 (0.091)

12. Secondary Outcome

Title	Number of Participants With Antitherapeutic Antibodies (ATA) to Brentuximab Vedotin
Description	Blood was collected and evaluated for ATA and neutralizing ATA in all participants who received brentuximab vedotin to assess immunogenicity.
Time Frame	Baseline up to End of Treatment (Week 52)

Outcome Measure Data

Analysis Population Description

The Safety population included participants who received at least one dose of study drug.

Arm/Group Title	pcALCL: Brentuximab Vedotin	MF: Brentuximab Vedotin 1.8 mg/kg
Arm/Group Description:	Participants with pcALCL received brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).	Participants with MF received brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
Overall Number of Participants Analyzed	16	50
Measure Type: Number; Unit of Measure: participants
Immunogenicity-evaluable participants	14	46
Baseline Negative: ATA negative	8	23
Baseline Negative: ATA positive	6	19
Baseline Negative: Transiently Positive	4	9
Baseline Negative: Persistently Positive	2	10
Baseline Negative: Neutralizing ATA Positive	4	14
Baseline Positive: ATA Negative	0	1
Baseline Positive: ATA Positive	0	3
Baseline Positive: Transiently Positive	0	3
Baseline Positive: Persistently Positive	0	0
Baseline Positive: Neutralizing ATA Positive	0	2

13. Secondary Outcome

Title	Change From Baseline in the Skindex-29 Questionnaire Total Score
Description	Skindex-29 is a 29-item dermatology-specific health-related quality of life (HRQoL). The Skindex-29 incorporates a 28-day recall period and consists of 3 domains: symptoms, emotions, and functioning. The domain scores and an overall score are expressed on a 100-point scale, 0 to 100 with higher scores indicating lower levels of health- HRQoL. A negative change (reduction) from Baseline indicates improvement.
Time Frame	Day 1 of Cycles 1, 2, 4, 6, 8, 10, 12, 14, 16, at End of Treatment (EOT) and during posttreatment long treatment follow-up (LTFU) - (Median follow-up 38.8 months)

Outcome Measure Data

Analysis Population Description

The ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment. Here 'Number analyzed' is the number of participants with evaluable data at the specified time-point.

Arm/Group Title		Brentuximab Vedotin	Methotrexate or Bexarotene
Arm/Group Description:		Brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).	Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m^2, tablets, orally, once daily with meals for up to 48 weeks.
Overall Number of Participants Analyzed		64	64
Mean (Standard Deviation); Unit of Measure: score on a scale
Change at Cycle 2	Number Analyzed	55 participants	45 participants
		-5.44 (11.055)	-2.49 (11.959)
Change at Cycle 4	Number Analyzed	49 participants	30 participants
		-14.60 (17.488)	-6.71 (9.755)
Change at Cycle 6	Number Analyzed	40 participants	25 participants
		-17.59 (17.770)	-5.40 (9.758)
Change at Cycle 8	Number Analyzed	37 participants	14 participants
		-21.73 (18.882)	-7.28 (16.769)
Change at Cycle 10	Number Analyzed	35 participants	13 participants
		-22.47 (21.722)	-3.71 (21.752)
Change at Cycle 12	Number Analyzed	25 participants	8 participants
		-23.37 (21.555)	-5.22 (17.704)
Change at Cycle 14	Number Analyzed	25 participants	5 participants
		-19.72 (20.980)	-7.49 (22.463)
Change at Cycle 16	Number Analyzed	22 participants	3 participants
		-19.35 (18.911)	0.75 (10.308)
Change at End of Treatment	Number Analyzed	47 participants	37 participants
		-16.26 (23.281)	-0.96 (18.973)
Change at 3-6 months LTFU	Number Analyzed	2 participants	3 participants
		-1.07 (3.704)	-9.48 (21.629)
Change at 6-9 months LTFU	Number Analyzed	6 participants	11 participants
		-8.04 (8.800)	-9.68 (17.789)
Change at 9-12 months LTFU	Number Analyzed	7 participants	10 participants
		-7.94 (15.582)	-4.93 (14.516)
Change at 12-15 months LTFU	Number Analyzed	25 participants	21 participants
		-16.21 (18.438)	-11.16 (18.183)
Change at 15-18 months LTFU	Number Analyzed	25 participants	18 participants
		-19.18 (19.475)	-8.53 (12.768)
Change at 18-21 months LTFU	Number Analyzed	22 participants	17 participants
		-19.27 (20.962)	-5.46 (16.679)
Change at 21-24 months LTFU	Number Analyzed	18 participants	19 participants
		-16.60 (19.875)	-6.86 (14.991)
Change at 24-27 months LTFU	Number Analyzed	21 participants	16 participants
		-17.04 (15.982)	-9.05 (23.990)
Change at 27-30 months LTFU	Number Analyzed	20 participants	18 participants
		-12.45 (19.639)	-7.97 (16.401)
Change at >30 months LTFU	Number Analyzed	23 participants	20 participants
		-11.49 (22.470)	-1.07 (18.886)

14. Secondary Outcome

Title	Change From Baseline in Functional Assessment of Cancer Therapy General Questionnaire (FACT-G) Score
Description	FACT-G is a 27-item general cancer QOL instrument completed by participants receiving cancer treatment. FACT-G incorporates a 7-day recall period and contains 4 primary subscales: Physical Well-Being (PWB; sum of 7 items, point range 0-28); Social/Family Well-Being (SWB, sum of 7-items, point range 0-28); Emotional Well-Being (EWB; sum of 6-items, point range 0-24); Functional Well-Being (FWB; sum of 7-items, point range 0-28); Fact-G total score=sum of PWB, SWB, EWB, FWB, point range 0-108. Higher scores for the total scales and subscales indicate better quality of life. A negative change (reduction) from Baseline indicates improvement.
Time Frame	Day 1 of Cycles 1, 2, 4, 6, 8, 10, 12, 14, 16, at EOT and during posttreatment (LTFU) - (Median follow-up 38.8 months)

Outcome Measure Data

Analysis Population Description

The ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment. Here 'Number analyzed' is the number of participants with evaluable data at the specified time-point.

Arm/Group Title		Brentuximab Vedotin	Methotrexate or Bexarotene
Arm/Group Description:		Brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).	Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m^2, tablets, orally, once daily with meals for up to 48 weeks.
Overall Number of Participants Analyzed		64	64
Mean (Standard Deviation); Unit of Measure: score on a scale
Change at Cycle 2	Number Analyzed	56 participants	46 participants
		1.43 (10.168)	-0.37 (11.723)
Change at Cycle 4	Number Analyzed	50 participants	32 participants
		1.75 (12.014)	1.78 (10.740)
Change at Cycle 6	Number Analyzed	40 participants	25 participants
		4.23 (14.257)	2.24 (13.108)
Change at Cycle 8	Number Analyzed	37 participants	13 participants
		5.96 (16.030)	2.54 (10.809)
Change at Cycle 10	Number Analyzed	35 participants	13 participants
		6.61 (16.971)	4.38 (15.040)
Change at Cycle 12	Number Analyzed	27 participants	8 participants
		7.94 (18.837)	8.61 (21.024)
Change at Cycle 14	Number Analyzed	26 participants	6 participants
		9.04 (14.104)	10.75 (13.615)
Change at Cycle 16	Number Analyzed	22 participants	4 participants
		5.08 (9.230)	7.88 (23.432)
Change at End of Treatment	Number Analyzed	47 participants	37 participants
		0.35 (16.067)	-2.29 (17.171)
Change at 3-6 months LTFU	Number Analyzed	2 participants	2 participants
		16.00 (18.385)	-2.92 (8.367)
Change at 6-9 months LTFU	Number Analyzed	6 participants	12 participants
		-0.19 (19.648)	-2.59 (12.473)
Change at 9-12 months LTFU	Number Analyzed	7 participants	10 participants
		3.62 (17.651)	-5.32 (10.555)
Change at 12-15 months LTFU	Number Analyzed	26 participants	19 participants
		8.33 (14.918)	-1.34 (11.905)
Change at 15-18 months LTFU	Number Analyzed	24 participants	18 participants
		3.03 (12.618)	2.94 (14.756)
Change at 18-21 months LTFU	Number Analyzed	24 participants	16 participants
		3.35 (11.117)	-0.19 (14.316)
Change at 21-24 months LTFU	Number Analyzed	17 participants	18 participants
		1.51 (5.471)	0.61 (14.505)
Change at 24-27 months LTFU	Number Analyzed	20 participants	15 participants
		4.20 (7.952)	1.42 (17.870)
Change at 27-30 months LTFU	Number Analyzed	19 participants	17 participants
		-1.57 (17.488)	1.93 (8.716)
Change at >30 months LTFU	Number Analyzed	22 participants	19 participants
		-6.22 (15.222)	-2.85 (5.518)

15. Secondary Outcome

Title	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description	AEs and SAEs were assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A SAE is any AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event.
Time Frame	First dose of study drug through 30 days after last dose of study drug (Up to 450 days)

Outcome Measure Data

Analysis Population Description

The Safety population included participants who received at least one dose of study drug.

Arm/Group Title	Brentuximab Vedotin	Methotrexate or Bexarotene
Arm/Group Description:	Brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).	Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m^2, tablets, orally, once daily with meals for up to 48 weeks.
Overall Number of Participants Analyzed	66	62
Measure Type: Number; Unit of Measure: participants
AEs	63	56
SAEs	18	18

Adverse Events

Time Frame	All-Cause mortality: Baseline up to End of study (Up to 6 years); Serious and Other adverse events: First dose of study drug through 30 days after last dose of study drug (Up to 450 days)
Adverse Event Reporting Description	At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Arm/Group Title	Brentuximab Vedotin	Methotrexate or Bexarotene
Arm/Group Description	Brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).	Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m^2, tablets, orally, once daily with meals for up to 48 weeks.
All-Cause Mortality
	Brentuximab Vedotin	Methotrexate or Bexarotene
	Affected / at Risk (%)	Affected / at Risk (%)
Total	22/66 (33.33%)	25/62 (40.32%)
Serious Adverse Events
	Brentuximab Vedotin	Methotrexate or Bexarotene
	Affected / at Risk (%)	Affected / at Risk (%)
Total	18/66 (27.27%)	18/62 (29.03%)
Blood and lymphatic system disorders
Haemolytic uraemic syndrome † 1	1/66 (1.52%)	0/62 (0.00%)
Gastrointestinal disorders
Pancreatitis † 1	1/66 (1.52%)	0/62 (0.00%)
Diarrhoea † 1	1/66 (1.52%)	0/62 (0.00%)
Intestinal perforation † 1	1/66 (1.52%)	0/62 (0.00%)
General disorders
Pyrexia † 1	2/66 (3.03%)	4/62 (6.45%)
Extravasation † 1	1/66 (1.52%)	0/62 (0.00%)
General physical health deterioration † 1	1/66 (1.52%)	0/62 (0.00%)
Multiple organ dysfunction syndrome † 1 [1]	1/66 (1.52%)	0/62 (0.00%)
Fatigue † 1	1/66 (1.52%)	0/62 (0.00%)
Hepatobiliary disorders
Hepatocellular injury † 1	1/66 (1.52%)	0/62 (0.00%)
Infections and infestations
Cellulitis † 1	2/66 (3.03%)	0/62 (0.00%)
Superinfection bacterial † 1	0/66 (0.00%)	1/62 (1.61%)
Diverticulitis † 1	1/66 (1.52%)	0/62 (0.00%)
Lower respiratory tract infection † 1	1/66 (1.52%)	0/62 (0.00%)
Sepsis † 1 [2]	1/66 (1.52%)	3/62 (4.84%)
Urosepsis † 1	0/66 (0.00%)	1/62 (1.61%)
Impetigo † 1	1/66 (1.52%)	0/62 (0.00%)
Sinusitis † 1	1/66 (1.52%)	0/62 (0.00%)
Urinary tract infection † 1	1/66 (1.52%)	0/62 (0.00%)
Parotitis † 1	0/66 (0.00%)	1/62 (1.61%)
Periorbital infection † 1	0/66 (0.00%)	1/62 (1.61%)
Erysipelas † 1	0/66 (0.00%)	1/62 (1.61%)
Skin infection † 1	0/66 (0.00%)	1/62 (1.61%)
Injury, poisoning and procedural complications
Fracture † 1	1/66 (1.52%)	0/62 (0.00%)
Metabolism and nutrition disorders
Hyperglycaemia † 1	1/66 (1.52%)	0/62 (0.00%)
Hypernatraemia † 1	0/66 (0.00%)	1/62 (1.61%)
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain † 1	1/66 (1.52%)	0/62 (0.00%)
Neck pain † 1	1/66 (1.52%)	0/62 (0.00%)
Crystal arthropathy † 1	0/66 (0.00%)	1/62 (1.61%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma † 1 [3]	1/66 (1.52%)	0/62 (0.00%)
Squamous cell carcinoma of skin † 1	0/66 (0.00%)	1/62 (1.61%)
Nervous system disorders
Dizziness † 1	1/66 (1.52%)	0/62 (0.00%)
Neuropathy peripheral † 1	1/66 (1.52%)	0/62 (0.00%)
Neuralgia † 1	0/66 (0.00%)	1/62 (1.61%)
Psychiatric disorders
Stress † 1	1/66 (1.52%)	0/62 (0.00%)
Renal and urinary disorders
Urinary retention † 1	1/66 (1.52%)	0/62 (0.00%)
Haematuria † 1	0/66 (0.00%)	1/62 (1.61%)
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism † 1 [4]	1/66 (1.52%)	0/62 (0.00%)
Skin and subcutaneous tissue disorders
Drug eruption † 1	1/66 (1.52%)	0/62 (0.00%)
Rash maculo-papular † 1	1/66 (1.52%)	0/62 (0.00%)
Dermatitis bullous † 1	0/66 (0.00%)	1/62 (1.61%)
Skin erosion † 1	0/66 (0.00%)	1/62 (1.61%)
Vascular disorders
Hypotension † 1	1/66 (1.52%)	0/62 (0.00%)
Peripheral vascular disorder † 1	0/66 (0.00%)	1/62 (1.61%)
Peripheral ischaemia † 1	0/66 (0.00%)	1/62 (1.61%)
1 Term from vocabulary, MedDRA 21.0; † Indicates events were collected by systematic assessment; [1] One treatment-emergent death occurred in participant with pcALCL during treatment with brentuximab vedotin and is related.; [2] One treatment-emergent death occurred in participant with sepsis during treatment with brentuximab vedotin and is not related.; [3] One treatment-emergent death occurred in participant with lymphoma during treatment with brentuximab vedotin and is not related.; [4] One treatment-emergent death occurred in participant with pulmonary embolism during treatment with brentuximab vedotin and is not related.
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Brentuximab Vedotin	Methotrexate or Bexarotene
	Affected / at Risk (%)	Affected / at Risk (%)
Total	60/66 (90.91%)	51/62 (82.26%)
Blood and lymphatic system disorders
Neutropenia † 1	5/66 (7.58%)	4/62 (6.45%)
Anaemia † 1	3/66 (4.55%)	6/62 (9.68%)
Endocrine disorders
Hypothyroidism † 1	0/66 (0.00%)	5/62 (8.06%)
Eye disorders
Dry eye † 1	0/66 (0.00%)	4/62 (6.45%)
Gastrointestinal disorders
Nausea † 1	24/66 (36.36%)	9/62 (14.52%)
Vomiting † 1	11/66 (16.67%)	3/62 (4.84%)
Diarrhoea † 1	18/66 (27.27%)	4/62 (6.45%)
Constipation † 1	3/66 (4.55%)	5/62 (8.06%)
General disorders
Fatigue † 1	18/66 (27.27%)	18/62 (29.03%)
Asthenia † 1	7/66 (10.61%)	5/62 (8.06%)
Pyrexia † 1	9/66 (13.64%)	8/62 (12.90%)
Oedema peripheral † 1	7/66 (10.61%)	6/62 (9.68%)
Chills † 1	4/66 (6.06%)	2/62 (3.23%)
Peripheral swelling † 1	1/66 (1.52%)	4/62 (6.45%)
Infections and infestations
Upper respiratory tract infection † 1	4/66 (6.06%)	2/62 (3.23%)
Skin infection † 1	2/66 (3.03%)	6/62 (9.68%)
Urinary tract infection † 1	4/66 (6.06%)	4/62 (6.45%)
Staphylococcal skin infection † 1	1/66 (1.52%)	5/62 (8.06%)
Investigations
Weight decreased † 1	6/66 (9.09%)	2/62 (3.23%)
Alanine aminotransferase increased † 1	3/66 (4.55%)	5/62 (8.06%)
Aspartate aminotransferase increased † 1	1/66 (1.52%)	4/62 (6.45%)
Blood cholesterol increased † 1	0/66 (0.00%)	4/62 (6.45%)
Blood triglycerides increased † 1	0/66 (0.00%)	5/62 (8.06%)
Metabolism and nutrition disorders
Decreased appetite † 1	10/66 (15.15%)	3/62 (4.84%)
Hyperglycaemia † 1	5/66 (7.58%)	0/62 (0.00%)
Hyperuricaemia † 1	4/66 (6.06%)	2/62 (3.23%)
Hypertriglyceridaemia † 1	1/66 (1.52%)	11/62 (17.74%)
Hypercholesterolaemia † 1	0/66 (0.00%)	4/62 (6.45%)
Musculoskeletal and connective tissue disorders
Pain in extremity † 1	6/66 (9.09%)	4/62 (6.45%)
Arthralgia † 1	8/66 (12.12%)	4/62 (6.45%)
Myalgia † 1	8/66 (12.12%)	2/62 (3.23%)
Muscle spasms † 1	4/66 (6.06%)	3/62 (4.84%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain † 1	1/66 (1.52%)	5/62 (8.06%)
Nervous system disorders
Peripheral sensory neuropathy † 1	31/66 (46.97%)	1/62 (1.61%)
Peripheral motor neuropathy † 1	4/66 (6.06%)	0/62 (0.00%)
Paraesthesia † 1	6/66 (9.09%)	1/62 (1.61%)
Dysgeusia † 1	5/66 (7.58%)	0/62 (0.00%)
Headache † 1	5/66 (7.58%)	6/62 (9.68%)
Dizziness † 1	4/66 (6.06%)	1/62 (1.61%)
Psychiatric disorders
Insomnia † 1	2/66 (3.03%)	6/62 (9.68%)
Anxiety † 1	0/66 (0.00%)	4/62 (6.45%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea † 1	7/66 (10.61%)	0/62 (0.00%)
Cough † 1	2/66 (3.03%)	4/62 (6.45%)
Skin and subcutaneous tissue disorders
Alopecia † 1	10/66 (15.15%)	2/62 (3.23%)
Rash maculo-papular † 1	7/66 (10.61%)	3/62 (4.84%)
Urticaria † 1	5/66 (7.58%)	1/62 (1.61%)
Dry skin † 1	1/66 (1.52%)	4/62 (6.45%)
Pruritus † 1	11/66 (16.67%)	8/62 (12.90%)
Pruritus generalised † 1	7/66 (10.61%)	1/62 (1.61%)
Vascular disorders
Hypertension † 1	6/66 (9.09%)	0/62 (0.00%)
1 Term from vocabulary, MedDRA 21.0; † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

In general, Investigators may publish clinical data after the earlier of (i) publication by the Sponsor or (ii) 12 months following the abandonment, early termination or database lock; provided a copy of the publication provided to Sponsor at least 30 days ahead of publication, the Sponsor's confidential information is removed as may be requested by Sponsor and Investigator defers publication for up to 60 days in the event Sponsor provides notice that it intends to file a patent application.

Results Point of Contact

• Name/Title: Medical Director
• Organization: Takeda
• Phone: +1-877-825-3327
• EMail: clinicaltrialregistry@tpna.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Horwitz SM, Scarisbrick JJ, Dummer R, Whittaker S, Duvic M, Kim YH, Quaglino P, Zinzani PL, Bechter O, Eradat H, Pinter-Brown L, Akilov OE, Geskin L, Sanches JA, Ortiz-Romero PL, Weichenthal M, Fisher DC, Walewski J, Trotman J, Taylor K, Dalle S, Stadler R, Lisano J, Bunn V, Little M, Prince HM. Randomized phase 3 ALCANZA study of brentuximab vedotin vs physician's choice in cutaneous T-cell lymphoma: final data. Blood Adv. 2021 Dec 14;5(23):5098-5106. doi: 10.1182/bloodadvances.2021004710.

Kim YH, Prince HM, Whittaker S, Horwitz SM, Duvic M, Bechter O, Sanches JA, Stadler R, Scarisbrick J, Quaglino P, Zinzani PL, Wolter P, Eradat H, Pinter-Brown LC, Ortiz-Romero PL, Akilov OE, Trotman J, Taylor K, Weichenthal M, Walewski J, Fisher D, McNeeley M, Gru AA, Brown L, Palanca-Wessels MC, Lisano J, Onsum M, Bunn V, Little M, Trepicchio WL, Dummer R. Response to brentuximab vedotin versus physician's choice by CD30 expression and large cell transformation status in patients with mycosis fungoides: An ALCANZA sub-analysis. Eur J Cancer. 2021 May;148:411-421. doi: 10.1016/j.ejca.2021.01.054. Epub 2021 Mar 29.

Valipour A, Jager M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD008946. doi: 10.1002/14651858.CD008946.pub3.

Dummer R, Prince HM, Whittaker S, Horwitz SM, Kim YH, Scarisbrick J, Quaglino P, Zinzani PL, Wolter P, Eradat H, Pinter-Brown L, Sanches JA, Ortiz-Romero PL, Akilov OE, Geskin L, Huen A, Walewski J, Wang Y, Lisano J, Richhariya A, Feliciano J, Zhu Y, Bunn V, Little M, Zagadailov E, Dalal MR, Duvic M. Patient-reported quality of life in patients with relapsed/refractory cutaneous T-cell lymphoma: Results from the randomised phase III ALCANZA study. Eur J Cancer. 2020 Jul;133:120-130. doi: 10.1016/j.ejca.2020.04.010. Epub 2020 Jun 2.

Prince HM, Kim YH, Horwitz SM, Dummer R, Scarisbrick J, Quaglino P, Zinzani PL, Wolter P, Sanches JA, Ortiz-Romero PL, Akilov OE, Geskin L, Trotman J, Taylor K, Dalle S, Weichenthal M, Walewski J, Fisher D, Dreno B, Stadler R, Feldman T, Kuzel TM, Wang Y, Palanca-Wessels MC, Zagadailov E, Trepicchio WL, Zhang W, Lin HM, Liu Y, Huebner D, Little M, Whittaker S, Duvic M; ALCANZA study group. Brentuximab vedotin or physician's choice in CD30-positive cutaneous T-cell lymphoma (ALCANZA): an international, open-label, randomised, phase 3, multicentre trial. Lancet. 2017 Aug 5;390(10094):555-566. doi: 10.1016/S0140-6736(17)31266-7. Epub 2017 Jun 7.

• Responsible Party: Takeda ( Millennium Pharmaceuticals, Inc. )
• ClinicalTrials.gov Identifier: NCT01578499
• Other Study ID Numbers: C25001; 2010-024215-14 ( EudraCT Number )
• First Submitted: March 27, 2012
• First Posted: April 17, 2012
• Results First Submitted: December 9, 2017
• Results First Posted: March 16, 2018
• Last Update Posted: January 5, 2021