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Immunomodulatory Agent

Venetoclax + Lenalidomide + Rituximab for Mantle Cell Lymphoma

Phase 1

Recruiting

Led By Tycel Phillips, M.D.

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Laboratory, radiographic, physical exam findings and/or symptoms attributable to MCL

ECOG Performance Status less or equal to 2

Must not have

Known history of CNS or leptomeningeal by MCL prior to study enrollment

Prior treatment for MCL with chemotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if an experimental drug called venetoclax, when combined with lenalidomide and rituximab, is safe and effective in treating people with Mantle Cell Lymphoma.

Who is the study for?

This trial is for adults over 18 with untreated Mantle Cell Lymphoma, who are in relatively good health (ECOG ≤2), not pregnant or breastfeeding, and can take oral medication. They must join the Revlimid REMS® program, agree to pregnancy testing if applicable, use contraception, and have no recent strong drug interactions or other cancers within 2 years.

What is being tested?

The study tests a combination of venetoclax with lenalidomide and rituximab for safety and effectiveness against MCL. Participants will receive this experimental treatment to see how well it works compared to current treatments.

What are the potential side effects?

Possible side effects include digestive issues, risk of infection due to lowered immune response, potential allergic reactions to drugs involved, fatigue from treatment regimen impact on body's normal function. Specific side effect profiles will be monitored closely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My tests show I have mantle cell lymphoma.

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I can take care of myself but might not be able to do heavy physical work.

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I am 18 years old or older.

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My diagnosis is mantle cell lymphoma confirmed by tissue examination.

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I am registered and can follow the Revlimid REMS program requirements.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread to my brain or spinal cord.

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I have received chemotherapy for mantle cell lymphoma.

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I have taken a strong or moderate drug that affects liver enzymes within the last week.

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I have a serious heart condition.

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I do not have an active Hepatitis B or C infection.

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I have moderate to severe numbness, tingling, or pain in my hands or feet.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

The proportion of patients that respond to treatment

The proportion of patients with a Complete Response (CR)

Side effects data

From 2022 Phase 3 trial • 389 Patients • NCT02005471

33%

Neutropenia

11%

SARS-CoV-2 test positive

11%

Sepsis

11%

Abdominal pain

11%

Pneumonia

11%

Rhinovirus infection

11%

COVID-19

11%

Gastroenteritis

11%

Pneumonia pseudomonal

11%

Electrocardiogram QT prolonged

11%

Anaemia

11%

Neutrophil count decreased

11%

Hypokalaemia

11%

Febrile neutropenia

11%

Supraventricular tachycardia

11%

Blood creatinine increased

11%

White blood cell count decreased

11%

Dermatitis

100%

80%

60%

40%

20%

Study treatment Arm

Bendamustine + Rituximab Crossover Substudy

Venetoclax + Rituximab Re-Treatment Substudy

Venetoclax + Rituximab Main Study

Bendamustine + Rituximab Main Study

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Venetoclax, Lenalidomide, RituximabExperimental Treatment3 Interventions

Rituximab 375 mg/m2 IV day 1, 8, 15, 22 of 1st cycle then on day 1 for cycles 2, 4, 6, 8, 10, 12 Lenalidomide 10 mg day 1-7 of and 15 mg day 8-14 cycle #1. 20 mg PO day day 15-21 of cycle #1 and days 1-21 cycles 2-12. Venetoclax PO days 8 - 28 cycles during cycle 1 only. Starting with ramp-up dose as follows (50 mg x 7 days then 100mg x 7 days then 200 mg x 7 days then 400 mg for remainder of therapy). Will be given days 1-28 at a dose of 400 mg cycle 2-12.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Venetoclax

2019

Completed Phase 3

~2240

Lenalidomide

2005

Completed Phase 3

~2240