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Trial Outcomes & Findings for Bendamustine, Obinutuzumab, and Venetoclax in Patients With Untreated Mantle Cell Lymphoma (NCT NCT03872180)

NCT ID: NCT03872180

Last Updated: 2025-08-06

Results Overview

Response will be assessed by positron emission tomography (PET)/computerized tomography (CT) imaging according to the Lugano Classification for response assessment in lymphoma, developed at the 2014 International Conference on Malignant Lymphoma.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

23 participants

Primary outcome timeframe

Up to 2.5 years from study start

Results posted on

2025-08-06

Participant Flow

Participant milestones

Participant milestones
Measure
Venetoclax, Bendamustine, Obinutuzumab
Patients receive venetoclax PO on days 1-28 of course 1 and days 1-10 of subsequent courses, bendamustine IV on days 1 and 2, and obinutuzumab IV on days 1, 8, and 15 of course 1 and day 1 of subsequent courses. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unaccepted toxicity. Bendamustine: Given IV Obinutuzumab: Given IV Venetoclax: Given PO
Overall Study
STARTED
23
Overall Study
COMPLETED
17
Overall Study
NOT COMPLETED
6

Reasons for withdrawal

Reasons for withdrawal
Measure
Venetoclax, Bendamustine, Obinutuzumab
Patients receive venetoclax PO on days 1-28 of course 1 and days 1-10 of subsequent courses, bendamustine IV on days 1 and 2, and obinutuzumab IV on days 1, 8, and 15 of course 1 and day 1 of subsequent courses. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unaccepted toxicity. Bendamustine: Given IV Obinutuzumab: Given IV Venetoclax: Given PO
Overall Study
Adverse Event
4
Overall Study
Lack of Efficacy
2

Baseline Characteristics

Bendamustine, Obinutuzumab, and Venetoclax in Patients With Untreated Mantle Cell Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Venetoclax, Bendamustine, Obinutuzumab
n=23 Participants
Patients receive venetoclax PO on days 1-28 of course 1 and days 1-10 of subsequent courses, bendamustine IV on days 1 and 2, and obinutuzumab IV on days 1, 8, and 15 of course 1 and day 1 of subsequent courses. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unaccepted toxicity. Bendamustine: Given IV Obinutuzumab: Given IV Venetoclax: Given PO
Age, Categorical
<=18 years
0 Participants
n=99 Participants
Age, Categorical
Between 18 and 65 years
15 Participants
n=99 Participants
Age, Categorical
>=65 years
8 Participants
n=99 Participants
Age, Continuous
61.74 Years
STANDARD_DEVIATION 10.31 • n=99 Participants
Sex: Female, Male
Female
6 Participants
n=99 Participants
Sex: Female, Male
Male
17 Participants
n=99 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=99 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
22 Participants
n=99 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants
n=99 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=99 Participants
Race (NIH/OMB)
Asian
0 Participants
n=99 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=99 Participants
Race (NIH/OMB)
White
21 Participants
n=99 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=99 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=99 Participants
Region of Enrollment
United States
23 participants
n=99 Participants

PRIMARY outcome

Timeframe: Up to 2.5 years from study start

Response will be assessed by positron emission tomography (PET)/computerized tomography (CT) imaging according to the Lugano Classification for response assessment in lymphoma, developed at the 2014 International Conference on Malignant Lymphoma.

Outcome measures

Outcome measures
Measure
Venetoclax, Bendamustine, Obinutuzumab
n=23 Participants
Patients receive venetoclax PO on days 1-28 of course 1 and days 1-10 of subsequent courses, bendamustine IV on days 1 and 2, and obinutuzumab IV on days 1, 8, and 15 of course 1 and day 1 of subsequent courses. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unaccepted toxicity. Bendamustine: Given IV Obinutuzumab: Given IV Venetoclax: Given PO
Rate of Complete Response at Completion of Induction Therapy With This Combination
Complete Response
19 Participants
Rate of Complete Response at Completion of Induction Therapy With This Combination
Partial Response
1 Participants
Rate of Complete Response at Completion of Induction Therapy With This Combination
Stable/Progressive Disease
3 Participants

SECONDARY outcome

Timeframe: Up to 6 years from study start

MRD will be assessed by peripheral blood using the ClonoSEQ assay available from Adaptive Biotechnologies.

Outcome measures

Outcome measures
Measure
Venetoclax, Bendamustine, Obinutuzumab
n=23 Participants
Patients receive venetoclax PO on days 1-28 of course 1 and days 1-10 of subsequent courses, bendamustine IV on days 1 and 2, and obinutuzumab IV on days 1, 8, and 15 of course 1 and day 1 of subsequent courses. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unaccepted toxicity. Bendamustine: Given IV Obinutuzumab: Given IV Venetoclax: Given PO
Rate of Minimal Residual Disease (MRD) Negative Complete Response by ClonoSEQ Mantle Cell Lymphoma (MCL) Assay
8.75 Percentage of participants
Interval 5.58 to 11.92

SECONDARY outcome

Timeframe: Up to 6 years from study start

Will be summarized descriptively.

Outcome measures

Outcome measures
Measure
Venetoclax, Bendamustine, Obinutuzumab
n=23 Participants
Patients receive venetoclax PO on days 1-28 of course 1 and days 1-10 of subsequent courses, bendamustine IV on days 1 and 2, and obinutuzumab IV on days 1, 8, and 15 of course 1 and day 1 of subsequent courses. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unaccepted toxicity. Bendamustine: Given IV Obinutuzumab: Given IV Venetoclax: Given PO
Overall Response Rate
Overall Response Rate (ORR)
20 Participants
Overall Response Rate
Non-Responders
3 Participants

SECONDARY outcome

Timeframe: Up to 6 years from study start

Will be summarized descriptively.

Outcome measures

Outcome measures
Measure
Venetoclax, Bendamustine, Obinutuzumab
n=23 Participants
Patients receive venetoclax PO on days 1-28 of course 1 and days 1-10 of subsequent courses, bendamustine IV on days 1 and 2, and obinutuzumab IV on days 1, 8, and 15 of course 1 and day 1 of subsequent courses. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unaccepted toxicity. Bendamustine: Given IV Obinutuzumab: Given IV Venetoclax: Given PO
Time to Tumor Progression
8.75 Months
Interval 5.58 to 11.92

SECONDARY outcome

Timeframe: Up to 6 years from study start

Will be described using the Kaplan-Meier methodology. Some patients may undergo consolidative autologous stem cell transplant without evidence of disease progression. This will not be counted against PFS.

Outcome measures

Outcome measures
Measure
Venetoclax, Bendamustine, Obinutuzumab
n=23 Participants
Patients receive venetoclax PO on days 1-28 of course 1 and days 1-10 of subsequent courses, bendamustine IV on days 1 and 2, and obinutuzumab IV on days 1, 8, and 15 of course 1 and day 1 of subsequent courses. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unaccepted toxicity. Bendamustine: Given IV Obinutuzumab: Given IV Venetoclax: Given PO
Progression Free Survival (PFS)
7.0 Months
Interval 1.0 to 14.0

SECONDARY outcome

Timeframe: Up to 6 years from study start

Will be described using the Kaplan-Meier methodology.

Outcome measures

Outcome measures
Measure
Venetoclax, Bendamustine, Obinutuzumab
n=23 Participants
Patients receive venetoclax PO on days 1-28 of course 1 and days 1-10 of subsequent courses, bendamustine IV on days 1 and 2, and obinutuzumab IV on days 1, 8, and 15 of course 1 and day 1 of subsequent courses. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unaccepted toxicity. Bendamustine: Given IV Obinutuzumab: Given IV Venetoclax: Given PO
Overall Survival
6-Month Survival
87.0 Percentage of patients
Interval 64.8 to 95.6
Overall Survival
12-Month Survival
78.3 Percentage of patients
Interval 55.4 to 90.3
Overall Survival
24-Month Survival
58.2 Percentage of patients
Interval 34.3 to 76.0
Overall Survival
36-Month Survival
51.7 Percentage of patients
Interval 27.9 to 71.1

Adverse Events

Venetoclax, Bendamustine, Obinutuzumab

Serious events: 8 serious events
Other events: 23 other events
Deaths: 10 deaths

Serious adverse events

Serious adverse events
Measure
Venetoclax, Bendamustine, Obinutuzumab
n=23 participants at risk
Patients receive venetoclax PO on days 1-28 of course 1 and days 1-10 of subsequent courses, bendamustine IV on days 1 and 2, and obinutuzumab IV on days 1, 8, and 15 of course 1 and day 1 of subsequent courses. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unaccepted toxicity. Bendamustine: Given IV Obinutuzumab: Given IV Venetoclax: Given PO
Respiratory, thoracic and mediastinal disorders
Pneumonitis
4.3%
1/23 • Number of events 1 • All-cause mortality was assessed up to 6 years and serious, and other (not including serious) Adverse Events were assessed up to 2.5 years.
Blood and lymphatic system disorders
Lymphocyte Count Decreased
4.3%
1/23 • Number of events 1 • All-cause mortality was assessed up to 6 years and serious, and other (not including serious) Adverse Events were assessed up to 2.5 years.
Cardiac disorders
Supraventricular Tachycardia
4.3%
1/23 • Number of events 1 • All-cause mortality was assessed up to 6 years and serious, and other (not including serious) Adverse Events were assessed up to 2.5 years.
General disorders
Fatigue
4.3%
1/23 • Number of events 1 • All-cause mortality was assessed up to 6 years and serious, and other (not including serious) Adverse Events were assessed up to 2.5 years.
Cardiac disorders
Myocardial Infarction
4.3%
1/23 • Number of events 1 • All-cause mortality was assessed up to 6 years and serious, and other (not including serious) Adverse Events were assessed up to 2.5 years.
Blood and lymphatic system disorders
Tumor Lysis Syndrome
4.3%
1/23 • Number of events 1 • All-cause mortality was assessed up to 6 years and serious, and other (not including serious) Adverse Events were assessed up to 2.5 years.
Blood and lymphatic system disorders
Hemorrhagic Shock
4.3%
1/23 • Number of events 1 • All-cause mortality was assessed up to 6 years and serious, and other (not including serious) Adverse Events were assessed up to 2.5 years.

Other adverse events

Other adverse events
Measure
Venetoclax, Bendamustine, Obinutuzumab
n=23 participants at risk
Patients receive venetoclax PO on days 1-28 of course 1 and days 1-10 of subsequent courses, bendamustine IV on days 1 and 2, and obinutuzumab IV on days 1, 8, and 15 of course 1 and day 1 of subsequent courses. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unaccepted toxicity. Bendamustine: Given IV Obinutuzumab: Given IV Venetoclax: Given PO
Metabolism and nutrition disorders
Hypoalbuminemia
13.0%
3/23 • Number of events 6 • All-cause mortality was assessed up to 6 years and serious, and other (not including serious) Adverse Events were assessed up to 2.5 years.
Metabolism and nutrition disorders
Hypocalcemia
13.0%
3/23 • Number of events 8 • All-cause mortality was assessed up to 6 years and serious, and other (not including serious) Adverse Events were assessed up to 2.5 years.
Metabolism and nutrition disorders
Hypokalemia
13.0%
3/23 • Number of events 3 • All-cause mortality was assessed up to 6 years and serious, and other (not including serious) Adverse Events were assessed up to 2.5 years.
Metabolism and nutrition disorders
Hyponatremia
13.0%
3/23 • Number of events 3 • All-cause mortality was assessed up to 6 years and serious, and other (not including serious) Adverse Events were assessed up to 2.5 years.
Metabolism and nutrition disorders
Hypophosphatemia
30.4%
7/23 • Number of events 12 • All-cause mortality was assessed up to 6 years and serious, and other (not including serious) Adverse Events were assessed up to 2.5 years.
Infections and infestations
Infections and infestations - Other, specify
17.4%
4/23 • Number of events 4 • All-cause mortality was assessed up to 6 years and serious, and other (not including serious) Adverse Events were assessed up to 2.5 years.
Injury, poisoning and procedural complications
Infusion related reaction
21.7%
5/23 • Number of events 7 • All-cause mortality was assessed up to 6 years and serious, and other (not including serious) Adverse Events were assessed up to 2.5 years.
Psychiatric disorders
Insomnia
21.7%
5/23 • Number of events 5 • All-cause mortality was assessed up to 6 years and serious, and other (not including serious) Adverse Events were assessed up to 2.5 years.
Investigations
Lymphocyte count decreased
56.5%
13/23 • Number of events 47 • All-cause mortality was assessed up to 6 years and serious, and other (not including serious) Adverse Events were assessed up to 2.5 years.
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
8.7%
2/23 • Number of events 4 • All-cause mortality was assessed up to 6 years and serious, and other (not including serious) Adverse Events were assessed up to 2.5 years.
Musculoskeletal and connective tissue disorders
Muscle cramp
8.7%
2/23 • Number of events 2 • All-cause mortality was assessed up to 6 years and serious, and other (not including serious) Adverse Events were assessed up to 2.5 years.
Respiratory, thoracic and mediastinal disorders
Nasal congestion
8.7%
2/23 • Number of events 2 • All-cause mortality was assessed up to 6 years and serious, and other (not including serious) Adverse Events were assessed up to 2.5 years.
Gastrointestinal disorders
Nausea
82.6%
19/23 • Number of events 24 • All-cause mortality was assessed up to 6 years and serious, and other (not including serious) Adverse Events were assessed up to 2.5 years.
Investigations
Neutrophil count decreased
26.1%
6/23 • Number of events 7 • All-cause mortality was assessed up to 6 years and serious, and other (not including serious) Adverse Events were assessed up to 2.5 years.
Gastrointestinal disorders
Oral pain
8.7%
2/23 • Number of events 2 • All-cause mortality was assessed up to 6 years and serious, and other (not including serious) Adverse Events were assessed up to 2.5 years.
General disorders
Pain
13.0%
3/23 • Number of events 3 • All-cause mortality was assessed up to 6 years and serious, and other (not including serious) Adverse Events were assessed up to 2.5 years.
Infections and infestations
Papulopustular rash
13.0%
3/23 • Number of events 4 • All-cause mortality was assessed up to 6 years and serious, and other (not including serious) Adverse Events were assessed up to 2.5 years.
Nervous system disorders
Paresthesia
8.7%
2/23 • Number of events 2 • All-cause mortality was assessed up to 6 years and serious, and other (not including serious) Adverse Events were assessed up to 2.5 years.
Investigations
Platelet count decreased
39.1%
9/23 • Number of events 26 • All-cause mortality was assessed up to 6 years and serious, and other (not including serious) Adverse Events were assessed up to 2.5 years.
Skin and subcutaneous tissue disorders
Rash maculo-papular
17.4%
4/23 • Number of events 6 • All-cause mortality was assessed up to 6 years and serious, and other (not including serious) Adverse Events were assessed up to 2.5 years.
Cardiac disorders
Sinus tachycardia
8.7%
2/23 • Number of events 2 • All-cause mortality was assessed up to 6 years and serious, and other (not including serious) Adverse Events were assessed up to 2.5 years.
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
17.4%
4/23 • Number of events 5 • All-cause mortality was assessed up to 6 years and serious, and other (not including serious) Adverse Events were assessed up to 2.5 years.
Social circumstances
Social circumstances - Other, specify
13.0%
3/23 • Number of events 4 • All-cause mortality was assessed up to 6 years and serious, and other (not including serious) Adverse Events were assessed up to 2.5 years.
Vascular disorders
Thromboembolic event
8.7%
2/23 • Number of events 2 • All-cause mortality was assessed up to 6 years and serious, and other (not including serious) Adverse Events were assessed up to 2.5 years.
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
8.7%
2/23 • Number of events 2 • All-cause mortality was assessed up to 6 years and serious, and other (not including serious) Adverse Events were assessed up to 2.5 years.
Metabolism and nutrition disorders
Tumor lysis syndrome
8.7%
2/23 • Number of events 2 • All-cause mortality was assessed up to 6 years and serious, and other (not including serious) Adverse Events were assessed up to 2.5 years.
Gastrointestinal disorders
Vomiting
43.5%
10/23 • Number of events 12 • All-cause mortality was assessed up to 6 years and serious, and other (not including serious) Adverse Events were assessed up to 2.5 years.
Gastrointestinal disorders
Abdominal distension
8.7%
2/23 • Number of events 2 • All-cause mortality was assessed up to 6 years and serious, and other (not including serious) Adverse Events were assessed up to 2.5 years.
Gastrointestinal disorders
Abdominal pain
34.8%
8/23 • Number of events 9 • All-cause mortality was assessed up to 6 years and serious, and other (not including serious) Adverse Events were assessed up to 2.5 years.
Investigations
Alkaline phosphatase increased
17.4%
4/23 • Number of events 4 • All-cause mortality was assessed up to 6 years and serious, and other (not including serious) Adverse Events were assessed up to 2.5 years.
Blood and lymphatic system disorders
Anemia
30.4%
7/23 • Number of events 18 • All-cause mortality was assessed up to 6 years and serious, and other (not including serious) Adverse Events were assessed up to 2.5 years.
Metabolism and nutrition disorders
Anorexia
21.7%
5/23 • Number of events 5 • All-cause mortality was assessed up to 6 years and serious, and other (not including serious) Adverse Events were assessed up to 2.5 years.
Psychiatric disorders
Anxiety
21.7%
5/23 • Number of events 5 • All-cause mortality was assessed up to 6 years and serious, and other (not including serious) Adverse Events were assessed up to 2.5 years.
Musculoskeletal and connective tissue disorders
Back pain
13.0%
3/23 • Number of events 3 • All-cause mortality was assessed up to 6 years and serious, and other (not including serious) Adverse Events were assessed up to 2.5 years.
Gastrointestinal disorders
Bloating
8.7%
2/23 • Number of events 2 • All-cause mortality was assessed up to 6 years and serious, and other (not including serious) Adverse Events were assessed up to 2.5 years.
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
17.4%
4/23 • Number of events 11 • All-cause mortality was assessed up to 6 years and serious, and other (not including serious) Adverse Events were assessed up to 2.5 years.
Musculoskeletal and connective tissue disorders
Bone pain
8.7%
2/23 • Number of events 2 • All-cause mortality was assessed up to 6 years and serious, and other (not including serious) Adverse Events were assessed up to 2.5 years.
General disorders
Chills
17.4%
4/23 • Number of events 5 • All-cause mortality was assessed up to 6 years and serious, and other (not including serious) Adverse Events were assessed up to 2.5 years.
Gastrointestinal disorders
Constipation
56.5%
13/23 • Number of events 17 • All-cause mortality was assessed up to 6 years and serious, and other (not including serious) Adverse Events were assessed up to 2.5 years.
Respiratory, thoracic and mediastinal disorders
Cough
21.7%
5/23 • Number of events 7 • All-cause mortality was assessed up to 6 years and serious, and other (not including serious) Adverse Events were assessed up to 2.5 years.
Psychiatric disorders
Depression
8.7%
2/23 • Number of events 2 • All-cause mortality was assessed up to 6 years and serious, and other (not including serious) Adverse Events were assessed up to 2.5 years.
Gastrointestinal disorders
Diarrhea
47.8%
11/23 • Number of events 18 • All-cause mortality was assessed up to 6 years and serious, and other (not including serious) Adverse Events were assessed up to 2.5 years.
Nervous system disorders
Dizziness
8.7%
2/23 • Number of events 3 • All-cause mortality was assessed up to 6 years and serious, and other (not including serious) Adverse Events were assessed up to 2.5 years.
Respiratory, thoracic and mediastinal disorders
Dyspnea
17.4%
4/23 • Number of events 5 • All-cause mortality was assessed up to 6 years and serious, and other (not including serious) Adverse Events were assessed up to 2.5 years.
Skin and subcutaneous tissue disorders
Erythema multiforme
8.7%
2/23 • Number of events 2 • All-cause mortality was assessed up to 6 years and serious, and other (not including serious) Adverse Events were assessed up to 2.5 years.
Nervous system disorders
Extrapyramidal disorder
8.7%
2/23 • Number of events 2 • All-cause mortality was assessed up to 6 years and serious, and other (not including serious) Adverse Events were assessed up to 2.5 years.
General disorders
Fatigue
65.2%
15/23 • Number of events 19 • All-cause mortality was assessed up to 6 years and serious, and other (not including serious) Adverse Events were assessed up to 2.5 years.
General disorders
Fever
26.1%
6/23 • Number of events 7 • All-cause mortality was assessed up to 6 years and serious, and other (not including serious) Adverse Events were assessed up to 2.5 years.
General disorders
Flu like symptoms
13.0%
3/23 • Number of events 3 • All-cause mortality was assessed up to 6 years and serious, and other (not including serious) Adverse Events were assessed up to 2.5 years.
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
8.7%
2/23 • Number of events 2 • All-cause mortality was assessed up to 6 years and serious, and other (not including serious) Adverse Events were assessed up to 2.5 years.
General disorders
General disorders and administration site conditions - Other, specify
13.0%
3/23 • Number of events 3 • All-cause mortality was assessed up to 6 years and serious, and other (not including serious) Adverse Events were assessed up to 2.5 years.
Nervous system disorders
Headache
39.1%
9/23 • Number of events 10 • All-cause mortality was assessed up to 6 years and serious, and other (not including serious) Adverse Events were assessed up to 2.5 years.
Metabolism and nutrition disorders
Hyperkalemia
26.1%
6/23 • Number of events 6 • All-cause mortality was assessed up to 6 years and serious, and other (not including serious) Adverse Events were assessed up to 2.5 years.
Vascular disorders
Hypertension
8.7%
2/23 • Number of events 2 • All-cause mortality was assessed up to 6 years and serious, and other (not including serious) Adverse Events were assessed up to 2.5 years.
Investigations
Weight loss
13.0%
3/23 • Number of events 4 • All-cause mortality was assessed up to 6 years and serious, and other (not including serious) Adverse Events were assessed up to 2.5 years.
Investigations
White blood cell decreased
21.7%
5/23 • Number of events 22 • All-cause mortality was assessed up to 6 years and serious, and other (not including serious) Adverse Events were assessed up to 2.5 years.

Additional Information

Dr. Jonathon Cohen

Emory University Hospital/Winship Cancer Institute

Phone: 4047781900

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place