A Phase 3 Study of Duvelisib Versus Ofatumumab in Patients With Relapsed or Refractory CLL/SLL (DUO)

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ClinicalTrials.gov Identifier: NCT02004522

Recruitment Status : Completed

First Posted : December 9, 2013

Results First Posted : January 8, 2019

Last Update Posted : September 21, 2023

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Sponsor:

Information provided by (Responsible Party):

SecuraBio

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Conditions	Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma
Interventions	Drug: Duvelisib Drug: Ofatumumab
Enrollment	319

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Duvelisib	Ofatumumab
Arm/Group Description	Duvelisib is administered orally an...	Ofatumumab is administered as an in...
Arm/Group Description	Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules.	Ofatumumab is administered as an intravenous (IV) infusion and is supplied in single-use vials at two strengths, 100 mg/5 mL and 1000 mg/50 mL.
Period Title: Overall Study
Started ^[1]	160	159
Number of Subjects Treated ^[2]	158	155
Completed	34 ^[3]	0 ^[3]
Not Completed	126	159
Reason Not Completed
Adverse Event	55	6
Withdrawal by Subject	13	7
Death	12	3
Physician Decision	3	4
Protocol Violation	1	0
Other is reason listed by PI	4	1
Never Dosed	2	4
Disease Progression	35	31
Completed Treatment Cycles Per Protocol	1	103
[1] Number of subjects randomized. [2] Number of subjects exposed to treatment. [3] Completed defined here as still on treatment.

Baseline Characteristics

Arm/Group Title		Duvelisib	Ofatumumab	Total
Arm/Group Description		Duvelisib is administered orally an...	Ofatumumab is administered as an IV...	Total of all reporting groups
Arm/Group Description		Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules.	Ofatumumab is administered as an IV infusion and is supplied in single-use vials at two strengths, 100 mg/5 mL and 1000 mg/50 mL.	Total of all reporting groups
Overall Number of Baseline Participants		160	159	319
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	160 participants	159 participants	319 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	48 30.0%	54 34.0%	102 32.0%
	>=65 years	112 70.0%	105 66.0%	217 68.0%
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	160 participants	159 participants	319 participants
	Female	64 40.0%	64 40.3%	128 40.1%
	Male	96 60.0%	95 59.7%	191 59.9%
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	160 participants	159 participants	319 participants
	Hispanic or Latino	8 5.0%	7 4.4%	15 4.7%
	Not Hispanic or Latino	130 81.3%	133 83.6%	263 82.4%
	Unknown or Not Reported	22 13.8%	19 11.9%	41 12.9%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	160 participants	159 participants	319 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	0 0.0%	0 0.0%	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	1 0.6%	1 0.6%	2 0.6%
	White	150 93.8%	142 89.3%	292 91.5%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	9 5.6%	16 10.1%	25 7.8%
Region of Enrollment Measure Type: Number Unit of measure: Participants	Number Analyzed	160 participants	159 participants	319 participants
New Zealand		6	6	12
Austria		3	8	11
Belgium		13	14	27
Hungary		35	30	65
United States		30	21	51
Italy		23	18	41
United Kingdom		7	10	17
Australia		9	12	21
France		12	18	30
Germany		1	3	4
Spain		21	19	40

Outcome Measures

1.Primary Outcome


Title	Progression-free Survival (PFS)
Description	The primary efficacy endpoint for the study was PFS, defined as time f...
Description	The primary efficacy endpoint for the study was PFS, defined as time from randomization to the first documentation of PD as determined by blinded independent review or death due to any cause.
Time Frame	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years

Outcome Measure Data

Analysis Population Description

Intent to Treat


Arm/Group Title	Duvelisib	Ofatumumab
Arm/Group Description:	Duvelisib is administered orally an...	Ofatumumab is administered as an IV...
Arm/Group Description:	Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules.	Ofatumumab is administered as an IV infusion and is supplied in single-use vials at two strengths, 100 mg/5 mL and 1000 mg/50 mL.
Overall Number of Participants Analyzed	160	159
Median (95% Confidence Interval) Unit of Measure: Months
	13.3 (12.1 to 16.8)	9.9 (9.2 to 11.3)

2.Secondary Outcome


Title	Overall Response Rate (ORR)
Description	ORR is a key secondary efficacy endpoint with overall response defined...
Description	ORR is a key secondary efficacy endpoint with overall response defined as best response of CR, CRi, PR, or PRwL, according to the modified IWCLL/IWG Response Criteria, with modification for treatment-related lymphocytosis as defined in the protocol.
Time Frame	Until disease progression or unacceptable toxicity assessed up to 6 years

Outcome Measure Data

Analysis Population Description

Intent to Treat


Arm/Group Title	Duvelisib	Ofatumumab
Arm/Group Description:	Duvelisib is administered orally an...	Ofatumumab is administered as an IV...
Arm/Group Description:	Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules.	Ofatumumab is administered as an IV infusion and is supplied in single-use vials at two strengths, 100 mg/5 mL and 1000 mg/50 mL.
Overall Number of Participants Analyzed	160	159
Measure Type: Count of Participants Unit of Measure: Participants
	118 73.8%	72 45.3%

3.Secondary Outcome


Title	Number of Subjects With Hematologic Improvements
Description	Subjects with hematologic improvement included those subjects with abn...
Description	Subjects with hematologic improvement included those subjects with abnormally high values for neutrophil count, hemoglobin, or platelet count at Baseline determined to have consistently met the criteria of an improvement for those parameters for a period of at least 60 days during which the subject did not have a transfusion or exogenous cytokines.
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

Subjects With Abnormal Hematologic Values at Baseline


Arm/Group Title	Duvelisib	Ofatumumab
Arm/Group Description:	Duvelisib is administered orally an...	Ofatumumab is administered as an IV...
Arm/Group Description:	Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules.	Ofatumumab is administered as an IV infusion and is supplied in single-use vials at two strengths, 100 mg/5 mL and 1000 mg/50 mL.
Overall Number of Participants Analyzed	94	95
Measure Type: Count of Participants Unit of Measure: Participants
	56 59.6%	51 53.7%

4.Secondary Outcome


Title	Overall Survival
Description	A stratified Cox regression analysis was used to test for any treatmen...
Description	A stratified Cox regression analysis was used to test for any treatment effect.
Time Frame	Every 6 months for up to 3 years after first dose

Outcome Measure Data

Analysis Population Description

Intent to Treat


Arm/Group Title	Duvelisib	Ofatumumab
Arm/Group Description:	Duvelisib is administered orally an...	Ofatumumab is administered as an IV...
Arm/Group Description:	Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules.	Ofatumumab is administered as an IV infusion and is supplied in single-use vials at two strengths, 100 mg/5 mL and 1000 mg/50 mL.
Overall Number of Participants Analyzed	160	159
Median (95% Confidence Interval) Unit of Measure: Months
	54.94 (43.00 to 67.99)	63.25 ^[1] (44.15 to NA)

[1]

NA = The upper limit of the confidence interval is not estimable because of an insufficient number of events at the time of analysis.

5.Secondary Outcome


Title	Lymph Node Response Rate
Description	Lymph node response defined as greater than or equal to 50% decrease i...
Description	Lymph node response defined as greater than or equal to 50% decrease in the SPD of target lymph nodes
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

Intent to Treat


Arm/Group Title	Duvelisib	Ofatumumab
Arm/Group Description:	Duvelisib is administered orally an...	Ofatumumab is administered as an IV...
Arm/Group Description:	Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules.	Ofatumumab is administered as an IV infusion and is supplied in single-use vials at two strengths, 100 mg/5 mL and 1000 mg/50 mL.
Overall Number of Participants Analyzed	160	159
Measure Type: Count of Participants Unit of Measure: Participants
	136 85.0%	25 15.7%

6.Secondary Outcome


Title	Duration of Response (DOR)
Description	Duration of response is defined only for subjects demonstrating a resp...
Description	Duration of response is defined only for subjects demonstrating a response (eg, CR, CRi, PR, PRwL), with the response and progression statuses both determined by the blinded, central independent review. The analysis will be descriptive for each treatment group only.
Time Frame	Time from the first documentation of response to first documentation of progressive disease or death due to any cause

Outcome Measure Data

Analysis Population Description

Intent to Treat


Arm/Group Title	Duvelisib	Ofatumumab
Arm/Group Description:	Duvelisib is administered orally an...	Ofatumumab is administered as an IV...
Arm/Group Description:	Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules.	Ofatumumab is administered as an IV infusion and is supplied in single-use vials at two strengths, 100 mg/5 mL and 1000 mg/50 mL.
Overall Number of Participants Analyzed	160	159
Median (95% Confidence Interval) Unit of Measure: Months
	11.1 (9.2 to 18.3)	9.3 (7.7 to 11.0)

7.Secondary Outcome


Title	Treatment-Emergent Adverse Events (TEAEs) and Changes in Safety Laboratory Values
Description	An analysis of TEAEs with an onset within the first 24 weeks of treatm...
Description	An analysis of TEAEs with an onset within the first 24 weeks of treatment was performed to examine and compare the incidence of events across an equal period for each treatment arm.Twenty-four weeks was anticipated to be the median exposure to ofatumumab.
Time Frame	From 04 Feb 2014 till 19 June 2018

Outcome Measure Data

Analysis Population Description

Intent to Treat


Arm/Group Title	Duvelisib	Ofatumumab
Arm/Group Description:	Duvelisib is administered orally an...	Ofatumumab is administered as an IV...
Arm/Group Description:	Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules.	Ofatumumab is administered as an IV infusion and is supplied in single-use vials at two strengths, 100 mg/5 mL and 1000 mg/50 mL.
Overall Number of Participants Analyzed	160	159
Measure Type: Count of Participants Unit of Measure: Participants
	150 93.8%	143 89.9%

8.Secondary Outcome


Title	Number of Subjects With Samples Available for Duvelisib Pharmacokinetics (PK)
Description	Number of subjects with samples available for duvelisib Pharmacokineti...
Description	Number of subjects with samples available for duvelisib Pharmacokinetics (PK)
Time Frame	Cycle 2, Cycle 3, and Cycle 7

Outcome Measure Data

Analysis Population Description

Intent to Treat for duvelisib patients, no PK samples were collected for ofatumumab patients.


Arm/Group Title	Duvelisib
Arm/Group Description:	Duvelisib is administered orally an...
Arm/Group Description:	Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules.
Overall Number of Participants Analyzed	160
Measure Type: Number Unit of Measure: participants
	158

Adverse Events

Time Frame	39 months
Adverse Event Reporting Description	Safety data rerun to include treatment-emergent adverse events that occurred on Day 1.

Arm/Group Title	Duvelisib	Ofatumumab
Arm/Group Description	Duvelisib is administered orally an...	Ofatumumab is administered as an IV...
Arm/Group Description	Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules.	Ofatumumab is administered as an IV infusion and is supplied in single-use vials at two strengths, 100 mg/5 mL and 1000 mg/50 mL.
All-Cause Mortality
	Duvelisib	Ofatumumab
	Affected / at Risk (%)	Affected / at Risk (%)
Total	78/158 (49.37%)	70/155 (45.16%)
Serious Adverse Events Serious Adverse Events
	Duvelisib	Ofatumumab
	Affected / at Risk (%)	Affected / at Risk (%)
Total	124/158 (78.48%)	50/155 (32.26%)
Blood and lymphatic system disorders
Febrile neutropenia ^† 1	10/158 (6.33%)	3/155 (1.94%)
Anaemia ^† 1	2/158 (1.27%)	2/155 (1.29%)
Haemolytic anaemia ^† 1	2/158 (1.27%)	1/155 (0.65%)
Pancytopenia ^† 1	3/158 (1.90%)	0/155 (0.00%)
Neutropenia ^† 1	1/158 (0.63%)	0/155 (0.00%)
Thrombocytopenia ^† 1	1/158 (0.63%)	0/155 (0.00%)
Lymph node pain ^† 1	0/158 (0.00%)	1/155 (0.65%)
Cardiac disorders
Atrial fibrillation ^† 1	2/158 (1.27%)	1/155 (0.65%)
Cardiac failure ^† 1	3/158 (1.90%)	1/155 (0.65%)
Cardiac failure congestive ^† 1	2/158 (1.27%)	0/155 (0.00%)
Myocardial infarction ^† 1	1/158 (0.63%)	0/155 (0.00%)
Pericarditis ^† 1	1/158 (0.63%)	0/155 (0.00%)
Ventricular tachycardia ^† 1	1/158 (0.63%)	0/155 (0.00%)
Angina pectoris ^† 1	0/158 (0.00%)	1/155 (0.65%)
Tachycardia ^† 1	0/158 (0.00%)	1/155 (0.65%)
Gastrointestinal disorders
Colitis ^† 1	20/158 (12.66%)	1/155 (0.65%)
Diarrhoea ^† 1	18/158 (11.39%)	1/155 (0.65%)
Enterocolitis ^† 1	2/158 (1.27%)	1/155 (0.65%)
Gastritis ^† 1	3/158 (1.90%)	0/155 (0.00%)
Upper gastrointestinal haemorrhage ^† 1	2/158 (1.27%)	0/155 (0.00%)
Abdominal pain ^† 1	1/158 (0.63%)	1/155 (0.65%)
Colitis ischaemic ^† 1	1/158 (0.63%)	0/155 (0.00%)
Enteritis ^† 1	1/158 (0.63%)	0/155 (0.00%)
Mallory-Weiss syndrome ^† 1	1/158 (0.63%)	0/155 (0.00%)
Pancreatitis acute ^† 1	1/158 (0.63%)	0/155 (0.00%)
Proctitis ^† 1	1/158 (0.63%)	0/155 (0.00%)
Oesophageal ulcer ^† 1	0/158 (0.00%)	1/155 (0.65%)
Portal hypertensive gastropathy ^† 1	0/158 (0.00%)	1/155 (0.65%)
Abdominal pain upper ^† 1	1/158 (0.63%)	0/155 (0.00%)
Ileal ulcer ^† 1	1/158 (0.63%)	0/155 (0.00%)
General disorders
Death ^† 1	2/158 (1.27%)	0/155 (0.00%)
Mucosal inflammation ^† 1	1/158 (0.63%)	0/155 (0.00%)
Multi-organ failure ^† 1	1/158 (0.63%)	0/155 (0.00%)
Oedema peripheral ^† 1	1/158 (0.63%)	0/155 (0.00%)
Sudden death ^† 1	1/158 (0.63%)	0/155 (0.00%)
Disease progression ^† 1	0/158 (0.00%)	2/155 (1.29%)
Fatigue ^† 1	0/158 (0.00%)	1/155 (0.65%)
Infusion site extravasation ^† 1	0/158 (0.00%)	1/155 (0.65%)
Pyrexia ^† 1	7/158 (4.43%)	1/155 (0.65%)
General physical health deterioration ^† 1	4/158 (2.53%)	0/155 (0.00%)
Hepatobiliary disorders
Cholecystitis ^† 1	0/158 (0.00%)	1/155 (0.65%)
Hepatic failure ^† 1	0/158 (0.00%)	1/155 (0.65%)
Immune system disorders
Contrast media allergy ^† 1	0/158 (0.00%)	1/155 (0.65%)
Drug hypersensitivity ^† 1	0/158 (0.00%)	1/155 (0.65%)
Infections and infestations
Pneumocystis jirovecii pneumonia ^† 1	3/158 (1.90%)	0/155 (0.00%)
Pneumonia pneumococcal ^† 1	3/158 (1.90%)	0/155 (0.00%)
Pneumonia pseudomonas aeruginosa ^† 1	3/158 (1.90%)	0/155 (0.00%)
Sepsis ^† 1	3/158 (1.90%)	1/155 (0.65%)
Upper respiratory tract infection ^† 1	3/158 (1.90%)	0/155 (0.00%)
Aspergillus infection ^† 1	2/158 (1.27%)	0/155 (0.00%)
Bronchopulmonary aspergillosis ^† 1	2/158 (1.27%)	0/155 (0.00%)
Campylobacter gastroenteritis ^† 1	2/158 (1.27%)	0/155 (0.00%)
Clostridium difficile colitis ^† 1	2/158 (1.27%)	0/155 (0.00%)
Fungal infection ^† 1	2/158 (1.27%)	0/155 (0.00%)
Influenza ^† 1	2/158 (1.27%)	0/155 (0.00%)
Lower respiratory tract infection ^† 1	2/158 (1.27%)	1/155 (0.65%)
Pneumonia bacterial ^† 1	2/158 (1.27%)	2/155 (1.29%)
Pneumonia staphylococcal ^† 1	2/158 (1.27%)	0/155 (0.00%)
Pseudomonal sepsis ^† 1	2/158 (1.27%)	0/155 (0.00%)
Skin infection ^† 1	2/158 (1.27%)	0/155 (0.00%)
Urinary tract infection ^† 1	2/158 (1.27%)	0/155 (0.00%)
Bronchiolitis ^† 1	1/158 (0.63%)	0/155 (0.00%)
Bronchitis viral ^† 1	1/158 (0.63%)	0/155 (0.00%)
Bronchopneumonia ^† 1	1/158 (0.63%)	0/155 (0.00%)
Cytomegalovirus colitis ^† 1	1/158 (0.63%)	0/155 (0.00%)
Diverticulitis ^† 1	1/158 (0.63%)	0/155 (0.00%)
Enterococcal infection ^† 1	1/158 (0.63%)	0/155 (0.00%)
Enterococcal sepsis ^† 1	1/158 (0.63%)	0/155 (0.00%)
Escherichia sepsis ^† 1	1/158 (0.63%)	3/155 (1.94%)
Escherichia urinary tract infection ^† 1	1/158 (0.63%)	2/155 (1.29%)
Gastroenteritis viral ^† 1	1/158 (0.63%)	0/155 (0.00%)
Haemophilus infection ^† 1	1/158 (0.63%)	0/155 (0.00%)
Infection ^† 1	1/158 (0.63%)	0/155 (0.00%)
Infusion site cellulitis ^† 1	1/158 (0.63%)	0/155 (0.00%)
Lobar pneumonia ^† 1	1/158 (0.63%)	0/155 (0.00%)
Lower respiratory tract infection viral ^† 1	1/158 (0.63%)	0/155 (0.00%)
Lung infection ^† 1	1/158 (0.63%)	0/155 (0.00%)
Pneumonia escherichia ^† 1	1/158 (0.63%)	0/155 (0.00%)
Pneumonia klebsiella ^† 1	1/158 (0.63%)	0/155 (0.00%)
Pneumonia mycoplasmal ^† 1	1/158 (0.63%)	0/155 (0.00%)
Pneumonia respiratory syncytial viral ^† 1	1/158 (0.63%)	0/155 (0.00%)
Pneumonia streptococcal ^† 1	1/158 (0.63%)	0/155 (0.00%)
Pseudomonas bronchitis ^† 1	1/158 (0.63%)	0/155 (0.00%)
Pyelonephritis ^† 1	1/158 (0.63%)	0/155 (0.00%)
Respiratory tract infection ^† 1	1/158 (0.63%)	0/155 (0.00%)
Respiratory tract infection bacterial ^† 1	1/158 (0.63%)	0/155 (0.00%)
Septic shock ^† 1	1/158 (0.63%)	0/155 (0.00%)
Streptococcal bacteraemia ^† 1	1/158 (0.63%)	1/155 (0.65%)
Streptococcal sepsis ^† 1	1/158 (0.63%)	0/155 (0.00%)
Wound infection staphylococcal ^† 1	1/158 (0.63%)	0/155 (0.00%)
Chronic sinusitis ^† 1	0/158 (0.00%)	1/155 (0.65%)
Clostridium difficile infection ^† 1	0/158 (0.00%)	1/155 (0.65%)
Device related infection ^† 1	0/158 (0.00%)	1/155 (0.65%)
Herpes virus infection ^† 1	0/158 (0.00%)	1/155 (0.65%)
Pneumonia viral ^† 1	0/158 (0.00%)	1/155 (0.65%)
Gastroenteritis ^† 1	4/158 (2.53%)	1/155 (0.65%)
Pneumonia ^† 1	25/158 (15.82%)	5/155 (3.23%)
Bronchitis ^† 1	5/158 (3.16%)	1/155 (0.65%)
Injury, poisoning and procedural complications
Accidental overdose ^† 1	1/158 (0.63%)	0/155 (0.00%)
Cervical vertebral fracture ^† 1	1/158 (0.63%)	0/155 (0.00%)
Femur fracture ^† 1	1/158 (0.63%)	0/155 (0.00%)
Splenic rupture ^† 1	1/158 (0.63%)	0/155 (0.00%)
Subdural haematoma ^† 1	1/158 (0.63%)	0/155 (0.00%)
Traumatic haematoma ^† 1	1/158 (0.63%)	0/155 (0.00%)
Fall ^† 1	0/158 (0.00%)	1/155 (0.65%)
Infusion related reaction ^† 1	0/158 (0.00%)	3/155 (1.94%)
Investigations
Alanine aminotransferase increased ^† 1	1/158 (0.63%)	0/155 (0.00%)
Aspartate aminotransferase increased ^† 1	1/158 (0.63%)	0/155 (0.00%)
Lipase increased ^† 1	1/158 (0.63%)	0/155 (0.00%)
Metabolism and nutrition disorders
Hypokalaemia ^† 1	1/158 (0.63%)	0/155 (0.00%)
Hyponatraemia ^† 1	1/158 (0.63%)	1/155 (0.65%)
Malnutrition ^† 1	1/158 (0.63%)	0/155 (0.00%)
Tumour lysis syndrome ^† 1	1/158 (0.63%)	0/155 (0.00%)
Hypercalcaemia ^† 1	0/158 (0.00%)	2/155 (1.29%)
Hyperglycaemia ^† 1	0/158 (0.00%)	1/155 (0.65%)
Hyperkalaemia ^† 1	0/158 (0.00%)	1/155 (0.65%)
Hypervolaemia ^† 1	0/158 (0.00%)	2/155 (1.29%)
Musculoskeletal and connective tissue disorders
Arthritis ^† 1	1/158 (0.63%)	0/155 (0.00%)
Bone pain ^† 1	1/158 (0.63%)	0/155 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intestinal adenocarcinoma ^† 1	1/158 (0.63%)	0/155 (0.00%)
Malignant melanoma ^† 1	1/158 (0.63%)	1/155 (0.65%)
Neuroendocrine carcinoma of the skin ^† 1	1/158 (0.63%)	0/155 (0.00%)
Neuroendocrine tumour ^† 1	1/158 (0.63%)	0/155 (0.00%)
Transitional cell carcinoma ^† 1	1/158 (0.63%)	0/155 (0.00%)
Glioblastoma multiforme ^† 1	0/158 (0.00%)	1/155 (0.65%)
Malignant pleural effusion ^† 1	0/158 (0.00%)	1/155 (0.65%)
Squamous cell carcinoma ^† 1	0/158 (0.00%)	1/155 (0.65%)
Squamous cell carcinoma of lung ^† 1	0/158 (0.00%)	1/155 (0.65%)
Nervous system disorders
Haemorrhagic stroke ^† 1	2/158 (1.27%)	0/155 (0.00%)
Brain stem haemorrhage ^† 1	1/158 (0.63%)	0/155 (0.00%)
Dementia ^† 1	1/158 (0.63%)	0/155 (0.00%)
Mental impairment ^† 1	1/158 (0.63%)	0/155 (0.00%)
Dizziness ^† 1	0/158 (0.00%)	1/155 (0.65%)
Headache ^† 1	0/158 (0.00%)	1/155 (0.65%)
Ischaemic stroke ^† 1	0/158 (0.00%)	1/155 (0.65%)
Renal and urinary disorders
Nephrolithiasis ^† 1	1/158 (0.63%)	0/155 (0.00%)
Renal colic ^† 1	1/158 (0.63%)	0/155 (0.00%)
Renal failure ^† 1	1/158 (0.63%)	0/155 (0.00%)
Renal failure chronic ^† 1	1/158 (0.63%)	0/155 (0.00%)
Renal failure acute ^† 1	4/158 (2.53%)	2/155 (1.29%)
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism ^† 1	3/158 (1.90%)	2/155 (1.29%)
Dyspnoea ^† 1	2/158 (1.27%)	0/155 (0.00%)
Interstitial lung disease ^† 1	2/158 (1.27%)	0/155 (0.00%)
Respiratory failure ^† 1	2/158 (1.27%)	0/155 (0.00%)
Acute respiratory distress syndrome ^† 1	1/158 (0.63%)	0/155 (0.00%)
Acute respiratory failure ^† 1	1/158 (0.63%)	0/155 (0.00%)
Chronic obstructive pulmonary disease ^† 1	1/158 (0.63%)	0/155 (0.00%)
Lung disorder ^† 1	1/158 (0.63%)	0/155 (0.00%)
Pleural effusion ^† 1	1/158 (0.63%)	0/155 (0.00%)
Pleural haemorrhage ^† 1	1/158 (0.63%)	0/155 (0.00%)
Pneumonia aspiration ^† 1	1/158 (0.63%)	0/155 (0.00%)
Laryngeal stenosis ^† 1	0/158 (0.00%)	1/155 (0.65%)
Pneumonitis ^† 1	6/158 (3.80%)	0/155 (0.00%)
Skin and subcutaneous tissue disorders
Dermatitis exfoliative ^† 1	2/158 (1.27%)	0/155 (0.00%)
Rash ^† 1	2/158 (1.27%)	0/155 (0.00%)
Rash erythematous ^† 1	2/158 (1.27%)	0/155 (0.00%)
Rash maculo-papular ^† 1	2/158 (1.27%)	0/155 (0.00%)
Dermatitis allergic ^† 1	1/158 (0.63%)	0/155 (0.00%)
Toxic skin eruption ^† 1	4/158 (2.53%)	0/155 (0.00%)
Vascular disorders
Deep vein thrombosis ^† 1	2/158 (1.27%)	1/155 (0.65%)
Hypertension ^† 1	1/158 (0.63%)	0/155 (0.00%)
Thrombosis ^† 1	1/158 (0.63%)	0/155 (0.00%)
Peripheral embolism ^† 1	0/158 (0.00%)	1/155 (0.65%)
1 Term from vocabulary, MedDRA version 16.1 † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Duvelisib	Ofatumumab
	Affected / at Risk (%)	Affected / at Risk (%)
Total	149/158 (94.30%)	130/155 (83.87%)
Blood and lymphatic system disorders
Neutropenia ^† 1	53/158 (33.54%)	32/155 (20.65%)
Anaemia ^† 1	39/158 (24.68%)	16/155 (10.32%)
Thrombocytopenia ^† 1	27/158 (17.09%)	9/155 (5.81%)
Gastrointestinal disorders
Diarrhoea ^† 1	79/158 (50.00%)	19/155 (12.26%)
Nausea ^† 1	38/158 (24.05%)	17/155 (10.97%)
Constipation ^† 1	27/158 (17.09%)	12/155 (7.74%)
Vomiting ^† 1	23/158 (14.56%)	10/155 (6.45%)
Abdominal pain ^† 1	17/158 (10.76%)	3/155 (1.94%)
Dyspepsia ^† 1	9/158 (5.70%)	4/155 (2.58%)
Abdominal pain upper ^† 1	9/158 (5.70%)	5/155 (3.23%)
Paraesthesia oral ^† 1	0/158 (0.00%)	10/155 (6.45%)
Colitis ^† 1	8/158 (5.06%)	1/155 (0.65%)
Dry mouth ^† 1	8/158 (5.06%)	1/155 (0.65%)
General disorders
Pyrexia ^† 1	46/158 (29.11%)	15/155 (9.68%)
Fatigue ^† 1	25/158 (15.82%)	18/155 (11.61%)
Asthenia ^† 1	20/158 (12.66%)	17/155 (10.97%)
Oedema peripheral ^† 1	16/158 (10.13%)	7/155 (4.52%)
Infections and infestations
Pneumonia ^† 1	8/158 (5.06%)	4/155 (2.58%)
Bronchitis ^† 1	20/158 (12.66%)	12/155 (7.74%)
Upper respiratory tract infection ^† 1	22/158 (13.92%)	12/155 (7.74%)
Nasopharyngitis ^† 1	13/158 (8.23%)	4/155 (2.58%)
Respiratory tract infection ^† 1	11/158 (6.96%)	3/155 (1.94%)
Injury, poisoning and procedural complications
Infusion related reaction ^† 1	2/158 (1.27%)	28/155 (18.06%)
Investigations
Alanine aminotransferase increased ^† 1	13/158 (8.23%)	3/155 (1.94%)
Weight decreased ^† 1	21/158 (13.29%)	3/155 (1.94%)
Aspartate aminotransferase increased ^† 1	15/158 (9.49%)	3/155 (1.94%)
Metabolism and nutrition disorders
Dehydration ^† 1	8/158 (5.06%)	1/155 (0.65%)
Hypokalaemia ^† 1	16/158 (10.13%)	3/155 (1.94%)
Hyperkalaemia ^† 1	11/158 (6.96%)	5/155 (3.23%)
Decreased appetite ^† 1	24/158 (15.19%)	5/155 (3.23%)
Musculoskeletal and connective tissue disorders
Pain in extremity ^† 1	9/158 (5.70%)	3/155 (1.94%)
Arthralgia ^† 1	11/158 (6.96%)	5/155 (3.23%)
Back pain ^† 1	12/158 (7.59%)	8/155 (5.16%)
Muscle spasms ^† 1	7/158 (4.43%)	8/155 (5.16%)
Nervous system disorders
Dizziness ^† 1	13/158 (8.23%)	5/155 (3.23%)
Headache ^† 1	13/158 (8.23%)	13/155 (8.39%)
Paraesthesia ^† 1	7/158 (4.43%)	15/155 (9.68%)
Psychiatric disorders
Insomnia ^† 1	8/158 (5.06%)	9/155 (5.81%)
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea ^† 1	9/158 (5.70%)	3/155 (1.94%)
Productive cough ^† 1	8/158 (5.06%)	2/155 (1.29%)
Cough ^† 1	36/158 (22.78%)	22/155 (14.19%)
Dyspnoea ^† 1	14/158 (8.86%)	9/155 (5.81%)
Skin and subcutaneous tissue disorders
Rash ^† 1	17/158 (10.76%)	18/155 (11.61%)
Rash maculo-papular ^† 1	9/158 (5.70%)	2/155 (1.29%)
Pruritus ^† 1	11/158 (6.96%)	9/155 (5.81%)
Vascular disorders
Hypertension ^† 1	13/158 (8.23%)	4/155 (2.58%)
Hypotension ^† 1	4/158 (2.53%)	8/155 (5.16%)
1 Term from vocabulary, MedDRA version 16.1 † 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 NOT 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.

Results Point of Contact

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Name/Title:	Beth Gregory, PharmD, MBA
Organization:	Secura Bio, Inc.
Phone:	1-702-254-0011
EMail:	bgregory@securabio.com

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

Flinn IW, Hillmen P, Montillo M, Nagy Z, Illes A, Etienne G, Delgado J, Kuss BJ, Tam CS, Gasztonyi Z, Offner F, Lunin S, Bosch F, Davids MS, Lamanna N, Jaeger U, Ghia P, Cymbalista F, Portell CA, Skarbnik AP, Cashen AF, Weaver DT, Kelly VM, Turnbull B, Stilgenbauer S. The phase 3 DUO trial: duvelisib vs ofatumumab in relapsed and refractory CLL/SLL. Blood. 2018 Dec 6;132(23):2446-2455. doi: 10.1182/blood-2018-05-850461. Epub 2018 Oct 4.

Layout table for additonal information

Responsible Party:	SecuraBio
ClinicalTrials.gov Identifier:	NCT02004522
Other Study ID Numbers:	IPI-145-07 2013-002405-61 ( EudraCT Number )
First Submitted:	November 13, 2013
First Posted:	December 9, 2013
Results First Submitted:	October 23, 2018
Results First Posted:	January 8, 2019
Last Update Posted:	September 21, 2023

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