Ibrutinib + Venetoclax in Untreated WM

• ClinicalTrials.gov Identifier: NCT04273139
• Recruitment Status: Active, not recruiting
• First Posted: February 17, 2020
• Results First Posted: April 23, 2024
• Last Update Posted: April 23, 2024
• Sponsor: Dana-Farber Cancer Institute
• Collaborators: AbbVie; Pharmacyclics LLC.
• Information provided by (Responsible Party): Jorge J. Castillo, MD, Dana-Farber Cancer Institute

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Sequential Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Conditions: Waldenstrom Macroglobulinemia; MYD88 Gene Mutation
• Interventions: Drug: IBRUTINIB; Drug: Venetoclax
• Enrollment: 45

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Ibrutinib and Venetoclax
Arm/Group Description	The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.; Ibrutinib will be administered at a predetermined dose, once daily for 28 days; TLS Prophylaxis (Treatment to reduce risk of tumor lysis syndrome) prior to first dose of venetoclax (and for at least the first 2 weeks of treatment); Venetoclax Cycle 2-24. PO daily, predetermined dosage ramp up during cycle 2. IBRUTINIB: Ibrutinib Cycle 1-24 will be administered at a predetermined dose, once daily for 28 days Venetoclax: Venetoclax Cycle 2-24 will be administered daily for 28 days. Predetermined dosage ramp up schedule during cycle 2.
Period Title: Overall Study
Started	45
Completed	45
Not Completed	0

Baseline Characteristics

Arm/Group Title		Ibrutinib and Venetoclax
Arm/Group Description		The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.; Ibrutinib will be administered at a predetermined dose, once daily for 28 days; TLS Prophylaxis (Treatment to reduce risk of tumor lysis syndrome) prior to first dose of venetoclax (and for at least the first 2 weeks of treatment); Venetoclax Cycle 2-24. PO daily, predetermined dosage ramp up during cycle 2. IBRUTINIB: Ibrutinib Cycle 1-24 will be administered at a predetermined dose, once daily for 28 days Venetoclax: Venetoclax Cycle 2-24 will be administered daily for 28 days. Predetermined dosage ramp up schedule during cycle 2.
Overall Number of Baseline Participants		45
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	45 participants
	<=18 years	0 0.0%
	Between 18 and 65 years	20 44.4%
	>=65 years	25 55.6%
Age, Continuous; Median (Full Range); Unit of measure: Years
	Number Analyzed	45 participants
		67; (39 to 81)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	45 participants
	Female	15 33.3%
	Male	30 66.7%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	45 participants
	Hispanic or Latino	0 0.0%
	Not Hispanic or Latino	43 95.6%
	Unknown or Not Reported	2 4.4%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	45 participants
	American Indian or Alaska Native	0 0.0%
	Asian	1 2.2%
	Native Hawaiian or Other Pacific Islander	0 0.0%
	Black or African American	0 0.0%
	White	42 93.3%
	More than one race	0 0.0%
	Unknown or Not Reported	2 4.4%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	45 participants
		45

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Very Good Partial Response Within 24 Cycles of Therapy
Description	Proportion of patients with VGPR to therapy within 24 cycles of therapy initiation. (VGPR is >90% reduction in serum IgM from baseline)
Time Frame	The primary objective of VGPR within 24 cycles of therapy was assessed starting at Cycle 3 Day 1 through the End of Treatment visit, range of 2 to 21 months after the initiation of therapy.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ibrutinib and Venetoclax
Arm/Group Description:	The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.; Ibrutinib will be administered at a predetermined dose, once daily for 28 days; TLS Prophylaxis (Treatment to reduce risk of tumor lysis syndrome) prior to first dose of venetoclax (and for at least the first 2 weeks of treatment); Venetoclax Cycle 2-24. PO daily, predetermined dosage ramp up during cycle 2. IBRUTINIB: Ibrutinib Cycle 1-24 will be administered at a predetermined dose, once daily for 28 days Venetoclax: Venetoclax Cycle 2-24 will be administered daily for 28 days. Predetermined dosage ramp up schedule during cycle 2.
Overall Number of Participants Analyzed	45
Measure Type: Count of Participants; Unit of Measure: Participants
	19 42.2%

2. Secondary Outcome

Title	Number of Participants With Complete Response (CR) After 6 Cycles
Description	Proportion of patients with a complete response after 6 cycles of therapy. A complete response (CR) is defined as having resolution of WM related symptoms, normalization of serum IgM levels with complete disappearance of IgM paraprotein by immunofixation, and resolution of any adenopathy or splenomegaly.
Time Frame	6 Cycles (28 day cycle)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ibrutinib and Venetoclax
Arm/Group Description:	The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.; Ibrutinib will be administered at a predetermined dose, once daily for 28 days; TLS Prophylaxis (Treatment to reduce risk of tumor lysis syndrome) prior to first dose of venetoclax (and for at least the first 2 weeks of treatment); Venetoclax Cycle 2-24. PO daily, predetermined dosage ramp up during cycle 2. IBRUTINIB: Ibrutinib Cycle 1-24 will be administered at a predetermined dose, once daily for 28 days Venetoclax: Venetoclax Cycle 2-24 will be administered daily for 28 days. Predetermined dosage ramp up schedule during cycle 2.
Overall Number of Participants Analyzed	45
Measure Type: Count of Participants; Unit of Measure: Participants
	0 0.0%

3. Secondary Outcome

Title	Number of Participants With Complete Response (CR) After 12 Cycles
Description	Proportion of patients with a complete response after 12 cycles of therapy. A complete response (CR) is defined as having resolution of WM related symptoms, normalization of serum IgM levels with complete disappearance of IgM paraprotein by immunofixation, and resolution of any adenopathy or splenomegaly.
Time Frame	12 Cycles (28 day cycle)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ibrutinib and Venetoclax
Arm/Group Description:	The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.; Ibrutinib will be administered at a predetermined dose, once daily for 28 days; TLS Prophylaxis (Treatment to reduce risk of tumor lysis syndrome) prior to first dose of venetoclax (and for at least the first 2 weeks of treatment); Venetoclax Cycle 2-24. PO daily, predetermined dosage ramp up during cycle 2. IBRUTINIB: Ibrutinib Cycle 1-24 will be administered at a predetermined dose, once daily for 28 days Venetoclax: Venetoclax Cycle 2-24 will be administered daily for 28 days. Predetermined dosage ramp up schedule during cycle 2.
Overall Number of Participants Analyzed	45
Measure Type: Count of Participants; Unit of Measure: Participants
	0 0.0%

4. Secondary Outcome

Title	Number of Participants With Complete Response (CR) After 24 Cycles
Description	Proportion of patients with a complete response after 24 cycles of therapy. A complete response (CR) is defined as having resolution of WM related symptoms, normalization of serum IgM levels with complete disappearance of IgM paraprotein by immunofixation, and resolution of any adenopathy or splenomegaly.
Time Frame	Complete response to therapy was assessed starting at Cycle 3 Day 1 through the End of Treatment visit, range of 2 to 21 months after the initiation of therapy.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ibrutinib and Venetoclax
Arm/Group Description:	The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.; Ibrutinib will be administered at a predetermined dose, once daily for 28 days; TLS Prophylaxis (Treatment to reduce risk of tumor lysis syndrome) prior to first dose of venetoclax (and for at least the first 2 weeks of treatment); Venetoclax Cycle 2-24. PO daily, predetermined dosage ramp up during cycle 2. IBRUTINIB: Ibrutinib Cycle 1-24 will be administered at a predetermined dose, once daily for 28 days Venetoclax: Venetoclax Cycle 2-24 will be administered daily for 28 days. Predetermined dosage ramp up schedule during cycle 2.
Overall Number of Participants Analyzed	45
Measure Type: Count of Participants; Unit of Measure: Participants
	0 0.0%

5. Secondary Outcome

Title	Overall Response
Description	Proportion of patients with minor response (MR) , partial response (PR), very good partial response (VGPR), or complete response (CR) to therapy.
Time Frame	72 months

Outcome Measure Data Not Reported

6. Secondary Outcome

Title	Rate of VGPR at 30 Months
Description	Proportion of patients with a VGPR at 30 months from beginning therapy.
Time Frame	30 Months

Outcome Measure Data Not Reported

7. Secondary Outcome

Title	Median Time to Response
Description	Time from treatment initiation until achievement of a minor response (reduction in serum IgM >25%) or better.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ibrutinib and Venetoclax
Arm/Group Description:	The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.; Ibrutinib will be administered at a predetermined dose, once daily for 28 days; TLS Prophylaxis (Treatment to reduce risk of tumor lysis syndrome) prior to first dose of venetoclax (and for at least the first 2 weeks of treatment); Venetoclax Cycle 2-24. PO daily, predetermined dosage ramp up during cycle 2. IBRUTINIB: Ibrutinib Cycle 1-24 will be administered at a predetermined dose, once daily for 28 days Venetoclax: Venetoclax Cycle 2-24 will be administered daily for 28 days. Predetermined dosage ramp up schedule during cycle 2.
Overall Number of Participants Analyzed	45
Median (95% Confidence Interval); Unit of Measure: months
	0.9; (0.9 to 1)

8. Secondary Outcome

Title	Median Time to Major Response
Description	Time from treatment initiation until partial response or better (>50% reduction in serum IgM)
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ibrutinib and Venetoclax
Arm/Group Description:	The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.; Ibrutinib will be administered at a predetermined dose, once daily for 28 days; TLS Prophylaxis (Treatment to reduce risk of tumor lysis syndrome) prior to first dose of venetoclax (and for at least the first 2 weeks of treatment); Venetoclax Cycle 2-24. PO daily, predetermined dosage ramp up during cycle 2. IBRUTINIB: Ibrutinib Cycle 1-24 will be administered at a predetermined dose, once daily for 28 days Venetoclax: Venetoclax Cycle 2-24 will be administered daily for 28 days. Predetermined dosage ramp up schedule during cycle 2.
Overall Number of Participants Analyzed	45
Median (95% Confidence Interval); Unit of Measure: months
	1.8; (1.4 to 1.9)

9. Secondary Outcome

Title	Progression Free Survival (PFS) at 24 Months
Description	Time from initiation of therapy until disease progression (>25% increase in serum IgM and 500 mg/dL absolute increase).
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ibrutinib and Venetoclax
Arm/Group Description:	The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.; Ibrutinib will be administered at a predetermined dose, once daily for 28 days; TLS Prophylaxis (Treatment to reduce risk of tumor lysis syndrome) prior to first dose of venetoclax (and for at least the first 2 weeks of treatment); Venetoclax Cycle 2-24. PO daily, predetermined dosage ramp up during cycle 2. IBRUTINIB: Ibrutinib Cycle 1-24 will be administered at a predetermined dose, once daily for 28 days Venetoclax: Venetoclax Cycle 2-24 will be administered daily for 28 days. Predetermined dosage ramp up schedule during cycle 2.
Overall Number of Participants Analyzed	45
Measure Type: Count of Participants; Unit of Measure: Participants
	34 75.6%

10. Secondary Outcome

Title	Progression Free Survival (PFS) at 36 Months
Description	Time from initiation of therapy until disease progression (>25% increase in serum IgM and 500 mg/dL absolute increase).
Time Frame	36 Months

Outcome Measure Data Not Reported

11. Secondary Outcome

Title	Progression Free Survival (PFS) at 48 Months
Description	Time from initiation of therapy until disease progression (>25% increase in serum IgM and 500 mg/dL absolute increase).
Time Frame	48 Months

Outcome Measure Data Not Reported

12. Secondary Outcome

Title	Progression Free Survival (PFS) at 60 Months
Description	Time from initiation of therapy until disease progression (>25% increase in serum IgM and 500 mg/dL absolute increase).
Time Frame	60 Months

Outcome Measure Data Not Reported

13. Secondary Outcome

Title	Overall Survival
Description	Time from initiation of therapy until death
Time Frame	72 months

Outcome Measure Data Not Reported

14. Secondary Outcome

Title	Time to Next Treatment
Description	Time from initiation of IVEN protocol therapy until initiation of new line of therapy.
Time Frame	72 months

Outcome Measure Data Not Reported

15. Secondary Outcome

Title	Number of Participants With Treatment Related Adverse Events as Assessed (CTCAE) Version 5.0
Description	CTCAE version 5.0
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ibrutinib and Venetoclax
Arm/Group Description:	The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.; Ibrutinib will be administered at a predetermined dose, once daily for 28 days; TLS Prophylaxis (Treatment to reduce risk of tumor lysis syndrome) prior to first dose of venetoclax (and for at least the first 2 weeks of treatment); Venetoclax Cycle 2-24. PO daily, predetermined dosage ramp up during cycle 2. IBRUTINIB: Ibrutinib Cycle 1-24 will be administered at a predetermined dose, once daily for 28 days Venetoclax: Venetoclax Cycle 2-24 will be administered daily for 28 days. Predetermined dosage ramp up schedule during cycle 2.
Overall Number of Participants Analyzed	45
Measure Type: Count of Participants; Unit of Measure: Participants
	45 100.0%

Adverse Events

Time Frame	Adverse events were collected from study treatment initiation through 30 days of last dose (e.g. 2 years)
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Ibrutinib and Venetoclax
Arm/Group Description	The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.; Ibrutinib will be administered at a predetermined dose, once daily for 28 days; TLS Prophylaxis (Treatment to reduce risk of tumor lysis syndrome) prior to first dose of venetoclax (and for at least the first 2 weeks of treatment); Venetoclax Cycle 2-24. PO daily, predetermined dosage ramp up during cycle 2. IBRUTINIB: Ibrutinib Cycle 1-24 will be administered at a predetermined dose, once daily for 28 days Venetoclax: Venetoclax Cycle 2-24 will be administered daily for 28 days. Predetermined dosage ramp up schedule during cycle 2.
All-Cause Mortality
	Ibrutinib and Venetoclax
	Affected / at Risk (%)
Total	2/45 (4.44%)
Serious Adverse Events
	Ibrutinib and Venetoclax
	Affected / at Risk (%)	# Events
Total	10/45 (22.22%)
Cardiac disorders
Ventricular tachycardia † 1	2/45 (4.44%)	2
Cardiac arrest † 1	2/45 (4.44%)	2
Hepatobiliary disorders
Cholecystitis † 1	1/45 (2.22%)	1
Infections and infestations
Aspiration pneumonia † 1	1/45 (2.22%)	1
Injury, poisoning and procedural complications
Fracture † 1	1/45 (2.22%)	1
Metabolism and nutrition disorders
Laboratory Tumor Lysis Syndrome † 1	1/45 (2.22%)	1
Hyperphosphatemia † 1	1/45 (2.22%)	1
Nervous system disorders
Intracranial hemorrhage † 1	1/45 (2.22%)	1
Vascular disorders
Hematoma † 1	1/45 (2.22%)	1
1 Term from vocabulary, CTCAE (4.0); † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Ibrutinib and Venetoclax
	Affected / at Risk (%)	# Events
Total	45/45 (100.00%)
Blood and lymphatic system disorders
Anemia † 1	8/45 (17.78%)	8
Easy bleeding † 1	6/45 (13.33%)	6
Petechia † 1	1/45 (2.22%)	1
Cardiac disorders
Atrial Fibrillation † 1	3/45 (6.67%)	3
Chest pain † 1	3/45 (6.67%)	3
Palpitations † 1	9/45 (20.00%)	9
Eye disorders
Blurred vision † 1	1/45 (2.22%)	1
Dry eye † 1	1/45 (2.22%)	1
Eye pain † 1	2/45 (4.44%)	2
Floaters † 1	1/45 (2.22%)	1
Retinal vein occlusion † 1	1/45 (2.22%)	1
Gastrointestinal disorders
Abdominal pain † 1	4/45 (8.89%)	4
Bloating † 1	3/45 (6.67%)	3
Constipation † 1	8/45 (17.78%)	8
Diarrhea † 1	26/45 (57.78%)	26
Dry mouth † 1	2/45 (4.44%)	2
Dyspepsia † 1	2/45 (4.44%)	2
Dysphagia † 1	1/45 (2.22%)	1
C. difficile infection † 1	1/45 (2.22%)	1
Flatulence † 1	7/45 (15.56%)	7
Gastroenteritis † 1	2/45 (4.44%)	2
GERD † 1	13/45 (28.89%)	13
Increased appetite † 1	1/45 (2.22%)	1
Hemorrhoidal hemorrhage † 1	1/45 (2.22%)	1
Mucositis oral † 1	16/45 (35.56%)	16
Nausea † 1	20/45 (44.44%)	20
Vomiting † 1	2/45 (4.44%)	2
General disorders
Chills † 1	1/45 (2.22%)	1
Edema limbs † 1	4/45 (8.89%)	4
Fatigue † 1	12/45 (26.67%)	12
Fever † 1	2/45 (4.44%)	2
Increased sensitivity to cold † 1	1/45 (2.22%)	1
Generalized edema † 1	3/45 (6.67%)	3
Malaise † 1	1/45 (2.22%)	1
Infections and infestations
Folliculitis † 1	2/45 (4.44%)	2
Gum infection † 1	1/45 (2.22%)	1
Herpes simplex reactivation † 1	1/45 (2.22%)	1
COVID-19 infection † 1	5/45 (11.11%)	5
Nail infection † 1	1/45 (2.22%)	1
Papulopustular rash † 1	2/45 (4.44%)	2
Shingles † 1	1/45 (2.22%)	1
Sinusitis † 1	2/45 (4.44%)	2
Skin infection † 1	2/45 (4.44%)	2
Soft tissue infection † 1	1/45 (2.22%)	1
Upper respiratory infection † 1	4/45 (8.89%)	4
Urinary tract infection † 1	3/45 (6.67%)	3
Injury, poisoning and procedural complications
Ankle fracture † 1	1/45 (2.22%)	1
Bruising † 1	16/45 (35.56%)	16
Fall † 1	2/45 (4.44%)	2
Spinal fracture † 1	1/45 (2.22%)	1
Wound complication † 1	3/45 (6.67%)	3
Investigations
ALT elevation † 1	3/45 (6.67%)	3
Alkaline phosphatase increased † 1	1/45 (2.22%)	1
AST elevation † 1	2/45 (4.44%)	2
LDH increased † 1	1/45 (2.22%)	1
Cardiac troponin t increased † 1	1/45 (2.22%)	1
Creatinine increased † 1	1/45 (2.22%)	1
Neutrophil count decreased † 1	16/45 (35.56%)	16
Platelet count decreased † 1	6/45 (13.33%)	6
Weight gain † 1	1/45 (2.22%)	1
Weight loss † 1	2/45 (4.44%)	2
Metabolism and nutrition disorders
Anorexia † 1	5/45 (11.11%)	5
Hyperphosphatemia † 1	7/45 (15.56%)	7
Hyperuricemia † 1	2/45 (4.44%)	2
Hypomagnesemia † 1	1/45 (2.22%)	1
Hyponatremia † 1	1/45 (2.22%)	1
Laboratory Tumor Lysis Syndrome † 1	1/45 (2.22%)	1
Musculoskeletal and connective tissue disorders
Arthralgia † 1	11/45 (24.44%)	11
Arthritis † 1	1/45 (2.22%)	1
Back pain † 1	6/45 (13.33%)	6
Bone pain † 1	1/45 (2.22%)	1
Generalized muscle weakness † 1	2/45 (4.44%)	2
Stiff joints † 1	1/45 (2.22%)	1
Muscle cramps † 1	7/45 (15.56%)	7
Plantar fascitis † 1	1/45 (2.22%)	1
Tendonitis † 1	1/45 (2.22%)	1
Myalgia † 1	7/45 (15.56%)	7
Myositis † 1	1/45 (2.22%)	1
Neck pain † 1	1/45 (2.22%)	1
Osteoporosis † 1	1/45 (2.22%)	1
Pain in extremity † 1	4/45 (8.89%)	4
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
DCIS left breast † 1	1/45 (2.22%)	1
Nervous system disorders
Dizziness † 1	10/45 (22.22%)	10
Dysgeusia † 1	1/45 (2.22%)	1
Headache † 1	6/45 (13.33%)	6
Imbalance † 1	2/45 (4.44%)	2
Paresthesia † 1	3/45 (6.67%)	3
Presyncope † 1	2/45 (4.44%)	2
Psychiatric disorders
Anxiety † 1	1/45 (2.22%)	1
Hallucinations † 1	1/45 (2.22%)	1
Insomnia † 1	3/45 (6.67%)	3
Irritability † 1	1/45 (2.22%)	1
Renal and urinary disorders
Hematuria † 1	2/45 (4.44%)	2
Urinary frequency † 1	1/45 (2.22%)	1
Urinary incontinence † 1	1/45 (2.22%)	1
Urinary retention † 1	1/45 (2.22%)	1
Urinary urgency † 1	1/45 (2.22%)	1
Reproductive system and breast disorders
Irregular menstruation † 1	1/45 (2.22%)	1
Bleeding † 1	1/45 (2.22%)	1
Respiratory, thoracic and mediastinal disorders
Bronchospasm † 1	1/45 (2.22%)	1
Cough † 1	2/45 (4.44%)	2
Dyspnea † 1	8/45 (17.78%)	8
Epistaxis † 1	1/45 (2.22%)	1
Hiccups † 1	1/45 (2.22%)	1
Nasal congestion † 1	2/45 (4.44%)	2
Sore throat † 1	1/45 (2.22%)	1
Skin and subcutaneous tissue disorders
Dry skin † 1	9/45 (20.00%)	9
Hair thining † 1	1/45 (2.22%)	1
Hyperhidrosis † 1	3/45 (6.67%)	3
Nail changes † 1	6/45 (13.33%)	6
Pain of skin † 1	1/45 (2.22%)	1
Pruritis † 1	2/45 (4.44%)	2
Purpura † 1	3/45 (6.67%)	3
Maculopapular Rash † 1	3/45 (6.67%)	3
Fragile skin † 1	11/45 (24.44%)	11
Lesion † 1	3/45 (6.67%)	3
Nodular rash † 1	1/45 (2.22%)	1
Skin changes † 1	2/45 (4.44%)	2
Rash not otherwise specified † 1	7/45 (15.56%)	7
skin induration † 1	1/45 (2.22%)	1
Vascular disorders
Hot flashes † 1	1/45 (2.22%)	1
Hypertension † 1	4/45 (8.89%)	4
Raynaud's symptoms † 1	1/45 (2.22%)	1
1 Term from vocabulary, CTCAE (4.0); † 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 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

• Name/Title: Jorge J. Castillo, Md
• Organization: Dana-Farber Cancer Institute
• Phone: 617-632-2681
• EMail: jorgej_castillo@dfci.harvard.edu

• Responsible Party: Jorge J. Castillo, MD, Dana-Farber Cancer Institute
• ClinicalTrials.gov Identifier: NCT04273139
• Other Study ID Numbers: 19-651
• First Submitted: February 14, 2020
• First Posted: February 17, 2020
• Results First Submitted: February 28, 2024
• Results First Posted: April 23, 2024
• Last Update Posted: April 23, 2024