Trial Outcomes & Findings for Phase II Trial of Venetoclax and Rituximab as Initial Therapy in Older Patients With Mantle Cell Lymphoma (NCT NCT05025423)
NCT ID: NCT05025423
Last Updated: 2026-06-10
Results Overview
The ORR will be the sum of complete (CR) and partial responses (PR)as determined by PET/CT and Lugano criteria. Simon's optimal two-stage design will be used to test the null hypothesis that the true ORR is 50% or less (not considered clinically acceptable).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
7 participants
Primary outcome timeframe
120 days
Results posted on
2026-06-10
Participant Flow
Participant milestones
| Measure |
Venetoclax and Rituximab in Patients Over 60 Yrs Old With Previously Untreated Mantle Cell Lymphoma
Venetoclax dose escalation for Cycles 1-4. If Complete response (CR) at Cycle 4, continue with cycles 5-12 at fixed venetoclax 400mg dose. If partial response (PR) at Cycle 4, continue with cycles 5-8 at fixed venetoclax 800mg dose. If CR at Cycle 8 after PR, continue with cycles 9-12 at fixed venetoclax 800mg dose. If continued PR at Cycle 8, reduce venetoclax to 400mg and add bendamustine 90 mg/m2.
Venetoclax Oral Tablet \[Venclexta\]: Sequential dose levels for Venetoclax dependent on patient response. Fixed doses of 375 mg/m2 rituximab. Fixed dose of Bendamustine 90 mg/m2 added for those with continued PR at Cycle 8
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase II Trial of Venetoclax and Rituximab as Initial Therapy in Older Patients With Mantle Cell Lymphoma
Baseline characteristics by cohort
| Measure |
Venetoclax and Rituximab in Patients Over 60 Yrs Old With Previously Untreated Mantle Cell Lymphoma
n=5 Participants
Venetoclax dose escalation for Cycles 1-4. If Complete response (CR) at Cycle 4, continue with cycles 5-12 at fixed venetoclax 400mg dose. If partial response (PR) at Cycle 4, continue with cycles 5-8 at fixed venetoclax 800mg dose. If CR at Cycle 8 after PR, continue with cycles 9-12 at fixed venetoclax 800mg dose. If continued PR at Cycle 8, reduce venetoclax to 400mg and add bendamustine 90 mg/m2.
Venetoclax Oral Tablet \[Venclexta\]: Sequential dose levels for Venetoclax dependent on patient response. Fixed doses of 375 mg/m2 rituximab. Fixed dose of Bendamustine 90 mg/m2 added for those with continued PR at Cycle 8
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=9 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=9 Participants
|
|
Age, Continuous
|
66 years
n=9 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: 120 daysThe ORR will be the sum of complete (CR) and partial responses (PR)as determined by PET/CT and Lugano criteria. Simon's optimal two-stage design will be used to test the null hypothesis that the true ORR is 50% or less (not considered clinically acceptable).
Outcome measures
| Measure |
Venetoclax and Rituximab in Patients Over 60 Yrs Old With Previously Untreated Mantle Cell Lymphoma
n=5 Participants
Venetoclax dose escalation for Cycles 1-4. If Complete response (CR) at Cycle 4, continue with cycles 5-12 at fixed venetoclax 400mg dose. If partial response (PR) at Cycle 4, continue with cycles 5-8 at fixed venetoclax 800mg dose. If CR at Cycle 8 after PR, continue with cycles 9-12 at fixed venetoclax 800mg dose. If continued PR at Cycle 8, reduce venetoclax to 400mg and add bendamustine 90 mg/m2.
Venetoclax Oral Tablet \[Venclexta\]: Sequential dose levels for Venetoclax dependent on patient response. Fixed doses of 375 mg/m2 rituximab. Fixed dose of Bendamustine 90 mg/m2 added for those with continued PR at Cycle 8
|
|---|---|
|
Overall Response Rate (ORR) After Four Cycles of Venetoclax and Rituximab.
|
4 Participants
|
SECONDARY outcome
Timeframe: 120 daysComplete Response as determined by PET/CT and Lugano criteria after four cycles
Outcome measures
| Measure |
Venetoclax and Rituximab in Patients Over 60 Yrs Old With Previously Untreated Mantle Cell Lymphoma
n=5 Participants
Venetoclax dose escalation for Cycles 1-4. If Complete response (CR) at Cycle 4, continue with cycles 5-12 at fixed venetoclax 400mg dose. If partial response (PR) at Cycle 4, continue with cycles 5-8 at fixed venetoclax 800mg dose. If CR at Cycle 8 after PR, continue with cycles 9-12 at fixed venetoclax 800mg dose. If continued PR at Cycle 8, reduce venetoclax to 400mg and add bendamustine 90 mg/m2.
Venetoclax Oral Tablet \[Venclexta\]: Sequential dose levels for Venetoclax dependent on patient response. Fixed doses of 375 mg/m2 rituximab. Fixed dose of Bendamustine 90 mg/m2 added for those with continued PR at Cycle 8
|
|---|---|
|
Complete Response
|
4 Participants
|
SECONDARY outcome
Timeframe: 120 daysPartial Response as determined by PET/CT and Lugano criteria after four cycles
Outcome measures
| Measure |
Venetoclax and Rituximab in Patients Over 60 Yrs Old With Previously Untreated Mantle Cell Lymphoma
n=5 Participants
Venetoclax dose escalation for Cycles 1-4. If Complete response (CR) at Cycle 4, continue with cycles 5-12 at fixed venetoclax 400mg dose. If partial response (PR) at Cycle 4, continue with cycles 5-8 at fixed venetoclax 800mg dose. If CR at Cycle 8 after PR, continue with cycles 9-12 at fixed venetoclax 800mg dose. If continued PR at Cycle 8, reduce venetoclax to 400mg and add bendamustine 90 mg/m2.
Venetoclax Oral Tablet \[Venclexta\]: Sequential dose levels for Venetoclax dependent on patient response. Fixed doses of 375 mg/m2 rituximab. Fixed dose of Bendamustine 90 mg/m2 added for those with continued PR at Cycle 8
|
|---|---|
|
Partial Response
|
0 Participants
|
SECONDARY outcome
Timeframe: 120 daysStable disease as determined by PET/CT and Lugano criteria after four cycles
Outcome measures
| Measure |
Venetoclax and Rituximab in Patients Over 60 Yrs Old With Previously Untreated Mantle Cell Lymphoma
n=5 Participants
Venetoclax dose escalation for Cycles 1-4. If Complete response (CR) at Cycle 4, continue with cycles 5-12 at fixed venetoclax 400mg dose. If partial response (PR) at Cycle 4, continue with cycles 5-8 at fixed venetoclax 800mg dose. If CR at Cycle 8 after PR, continue with cycles 9-12 at fixed venetoclax 800mg dose. If continued PR at Cycle 8, reduce venetoclax to 400mg and add bendamustine 90 mg/m2.
Venetoclax Oral Tablet \[Venclexta\]: Sequential dose levels for Venetoclax dependent on patient response. Fixed doses of 375 mg/m2 rituximab. Fixed dose of Bendamustine 90 mg/m2 added for those with continued PR at Cycle 8
|
|---|---|
|
Stable Disease
|
0 Participants
|
SECONDARY outcome
Timeframe: 120 daysDisease progression as determined by PET/CT and Lugano criteria after four cycles
Outcome measures
| Measure |
Venetoclax and Rituximab in Patients Over 60 Yrs Old With Previously Untreated Mantle Cell Lymphoma
n=5 Participants
Venetoclax dose escalation for Cycles 1-4. If Complete response (CR) at Cycle 4, continue with cycles 5-12 at fixed venetoclax 400mg dose. If partial response (PR) at Cycle 4, continue with cycles 5-8 at fixed venetoclax 800mg dose. If CR at Cycle 8 after PR, continue with cycles 9-12 at fixed venetoclax 800mg dose. If continued PR at Cycle 8, reduce venetoclax to 400mg and add bendamustine 90 mg/m2.
Venetoclax Oral Tablet \[Venclexta\]: Sequential dose levels for Venetoclax dependent on patient response. Fixed doses of 375 mg/m2 rituximab. Fixed dose of Bendamustine 90 mg/m2 added for those with continued PR at Cycle 8
|
|---|---|
|
Disease Progression
|
1 Participants
|
SECONDARY outcome
Timeframe: 240 daysPopulation: Includes participants who received 8 cycles
Complete Response as determined by PET/CT and Lugano criteria after 8 cycles of venetoclax and rituximab
Outcome measures
| Measure |
Venetoclax and Rituximab in Patients Over 60 Yrs Old With Previously Untreated Mantle Cell Lymphoma
n=4 Participants
Venetoclax dose escalation for Cycles 1-4. If Complete response (CR) at Cycle 4, continue with cycles 5-12 at fixed venetoclax 400mg dose. If partial response (PR) at Cycle 4, continue with cycles 5-8 at fixed venetoclax 800mg dose. If CR at Cycle 8 after PR, continue with cycles 9-12 at fixed venetoclax 800mg dose. If continued PR at Cycle 8, reduce venetoclax to 400mg and add bendamustine 90 mg/m2.
Venetoclax Oral Tablet \[Venclexta\]: Sequential dose levels for Venetoclax dependent on patient response. Fixed doses of 375 mg/m2 rituximab. Fixed dose of Bendamustine 90 mg/m2 added for those with continued PR at Cycle 8
|
|---|---|
|
Complete Response After 8 Cycles of Venetoclax and Rituximab
|
4 Participants
|
SECONDARY outcome
Timeframe: 240 daysPopulation: Includes participants who received 8 cycles
Partial Response as determined by PET/CT and Lugano criteria after 8 cycles of venetoclax and rituximab
Outcome measures
| Measure |
Venetoclax and Rituximab in Patients Over 60 Yrs Old With Previously Untreated Mantle Cell Lymphoma
n=4 Participants
Venetoclax dose escalation for Cycles 1-4. If Complete response (CR) at Cycle 4, continue with cycles 5-12 at fixed venetoclax 400mg dose. If partial response (PR) at Cycle 4, continue with cycles 5-8 at fixed venetoclax 800mg dose. If CR at Cycle 8 after PR, continue with cycles 9-12 at fixed venetoclax 800mg dose. If continued PR at Cycle 8, reduce venetoclax to 400mg and add bendamustine 90 mg/m2.
Venetoclax Oral Tablet \[Venclexta\]: Sequential dose levels for Venetoclax dependent on patient response. Fixed doses of 375 mg/m2 rituximab. Fixed dose of Bendamustine 90 mg/m2 added for those with continued PR at Cycle 8
|
|---|---|
|
Partial Response After 8 Cycles of Venetoclax and Rituximab
|
0 Participants
|
SECONDARY outcome
Timeframe: 240 daysTo evaluate the progression free survival (PFS) in the intent to treat (ITT) population
Outcome measures
| Measure |
Venetoclax and Rituximab in Patients Over 60 Yrs Old With Previously Untreated Mantle Cell Lymphoma
n=5 Participants
Venetoclax dose escalation for Cycles 1-4. If Complete response (CR) at Cycle 4, continue with cycles 5-12 at fixed venetoclax 400mg dose. If partial response (PR) at Cycle 4, continue with cycles 5-8 at fixed venetoclax 800mg dose. If CR at Cycle 8 after PR, continue with cycles 9-12 at fixed venetoclax 800mg dose. If continued PR at Cycle 8, reduce venetoclax to 400mg and add bendamustine 90 mg/m2.
Venetoclax Oral Tablet \[Venclexta\]: Sequential dose levels for Venetoclax dependent on patient response. Fixed doses of 375 mg/m2 rituximab. Fixed dose of Bendamustine 90 mg/m2 added for those with continued PR at Cycle 8
|
|---|---|
|
Rate of Progression Free Survival (PFS)
|
4 Participants
|
SECONDARY outcome
Timeframe: 240 daysTo evaluate the overall survival (OS) in the intent to treat (ITT) population
Outcome measures
| Measure |
Venetoclax and Rituximab in Patients Over 60 Yrs Old With Previously Untreated Mantle Cell Lymphoma
n=5 Participants
Venetoclax dose escalation for Cycles 1-4. If Complete response (CR) at Cycle 4, continue with cycles 5-12 at fixed venetoclax 400mg dose. If partial response (PR) at Cycle 4, continue with cycles 5-8 at fixed venetoclax 800mg dose. If CR at Cycle 8 after PR, continue with cycles 9-12 at fixed venetoclax 800mg dose. If continued PR at Cycle 8, reduce venetoclax to 400mg and add bendamustine 90 mg/m2.
Venetoclax Oral Tablet \[Venclexta\]: Sequential dose levels for Venetoclax dependent on patient response. Fixed doses of 375 mg/m2 rituximab. Fixed dose of Bendamustine 90 mg/m2 added for those with continued PR at Cycle 8
|
|---|---|
|
Overall Survival (OS)
|
5 Participants
|
SECONDARY outcome
Timeframe: 25 monthsTo evaluate the duration of response (DOR) for participants achieving a CR or PR
Outcome measures
| Measure |
Venetoclax and Rituximab in Patients Over 60 Yrs Old With Previously Untreated Mantle Cell Lymphoma
n=4 Participants
Venetoclax dose escalation for Cycles 1-4. If Complete response (CR) at Cycle 4, continue with cycles 5-12 at fixed venetoclax 400mg dose. If partial response (PR) at Cycle 4, continue with cycles 5-8 at fixed venetoclax 800mg dose. If CR at Cycle 8 after PR, continue with cycles 9-12 at fixed venetoclax 800mg dose. If continued PR at Cycle 8, reduce venetoclax to 400mg and add bendamustine 90 mg/m2.
Venetoclax Oral Tablet \[Venclexta\]: Sequential dose levels for Venetoclax dependent on patient response. Fixed doses of 375 mg/m2 rituximab. Fixed dose of Bendamustine 90 mg/m2 added for those with continued PR at Cycle 8
|
|---|---|
|
Duration of Response (DOR)
|
20.5 months
Interval 20.0 to 25.0
|
Adverse Events
Venetoclax and Rituximab in Patients Over 60 Yrs Old With Previously Untreated Mantle Cell Lymphoma
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Venetoclax and Rituximab in Patients Over 60 Yrs Old With Previously Untreated Mantle Cell Lymphoma
n=7 participants at risk
Venetoclax dose escalation for Cycles 1-4. If Complete response (CR) at Cycle 4, continue with cycles 5-12 at fixed venetoclax 400mg dose. If partial response (PR) at Cycle 4, continue with cycles 5-8 at fixed venetoclax 800mg dose. If CR at Cycle 8 after PR, continue with cycles 9-12 at fixed venetoclax 800mg dose. If continued PR at Cycle 8, reduce venetoclax to 400mg and add bendamustine 90 mg/m2.
Venetoclax Oral Tablet \[Venclexta\]: Sequential dose levels for Venetoclax dependent on patient response. Fixed doses of 375 mg/m2 rituximab. Fixed dose of Bendamustine 90 mg/m2 added for those with continued PR at Cycle 8
|
|---|---|
|
General disorders
tumor lysis syndrome
|
14.3%
1/7 • from the time of initial study drug administration up to 30 days post discontinuation of study drug administration
|
|
General disorders
Infusion reaction
|
14.3%
1/7 • from the time of initial study drug administration up to 30 days post discontinuation of study drug administration
|
Other adverse events
| Measure |
Venetoclax and Rituximab in Patients Over 60 Yrs Old With Previously Untreated Mantle Cell Lymphoma
n=7 participants at risk
Venetoclax dose escalation for Cycles 1-4. If Complete response (CR) at Cycle 4, continue with cycles 5-12 at fixed venetoclax 400mg dose. If partial response (PR) at Cycle 4, continue with cycles 5-8 at fixed venetoclax 800mg dose. If CR at Cycle 8 after PR, continue with cycles 9-12 at fixed venetoclax 800mg dose. If continued PR at Cycle 8, reduce venetoclax to 400mg and add bendamustine 90 mg/m2.
Venetoclax Oral Tablet \[Venclexta\]: Sequential dose levels for Venetoclax dependent on patient response. Fixed doses of 375 mg/m2 rituximab. Fixed dose of Bendamustine 90 mg/m2 added for those with continued PR at Cycle 8
|
|---|---|
|
Investigations
lymphocyte count decreased
|
14.3%
1/7 • from the time of initial study drug administration up to 30 days post discontinuation of study drug administration
|
|
Investigations
hypercalcemia
|
14.3%
1/7 • from the time of initial study drug administration up to 30 days post discontinuation of study drug administration
|
|
Investigations
anemia
|
14.3%
1/7 • from the time of initial study drug administration up to 30 days post discontinuation of study drug administration
|
|
Blood and lymphatic system disorders
white blood cell (WBC) decrease
|
14.3%
1/7 • from the time of initial study drug administration up to 30 days post discontinuation of study drug administration
|
|
Blood and lymphatic system disorders
absolute neutrophil count (ANC) decreased
|
14.3%
1/7 • from the time of initial study drug administration up to 30 days post discontinuation of study drug administration
|
|
Renal and urinary disorders
acute kidney injury
|
14.3%
1/7 • from the time of initial study drug administration up to 30 days post discontinuation of study drug administration
|
|
Cardiac disorders
myocardial infarction
|
14.3%
1/7 • from the time of initial study drug administration up to 30 days post discontinuation of study drug administration
|
Additional Information
Lode Swinnen, MD- Principal Investigator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Phone: 410-614-6398
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place