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BCL-2 Inhibitor

Venetoclax + Rituximab for Mantle Cell Lymphoma

Phase 2

Recruiting

Led By Lode Swinnen, MD

Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Eligibility Criteria Checklist

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

Must have

Age ≥ 60

Female subjects not surgically sterile or postmenopausal and non-vasectomized male subjects must practice at least 1 specified method of birth control

Must not have

Subject has Ann Arbor stage I or contiguous stage II mantle cell lymphoma

Subject has an uncontrolled infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 240 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new combination of drugs to treat mantle cell lymphoma in patients over 60 who have not been treated before. The goal is to see if this new combination of drugs is effective in treating this form of cancer without the use of chemotherapy.

Who is the study for?

This trial is for people over 60 with a new diagnosis of mantle cell lymphoma who need treatment but haven't had any yet. They should be in fairly good health, able to perform daily activities, and have decent blood counts and organ function. Pregnant or breastfeeding women can't join, nor can those with certain types of the disease, uncontrolled infections, HIV, hepatitis B or C.

What is being tested?

The study tests Venetoclax tablets combined with Rituximab injections as an initial therapy for older patients with mantle cell lymphoma. It's an open-label phase II trial aiming to see if this drug combo works well without chemotherapy by measuring overall response rates using PET/CT scans.

What are the potential side effects?

Venetoclax and Rituximab may cause side effects like low blood cell counts leading to increased infection risk or bleeding problems, fatigue, nausea, diarrhea. There might also be allergic reactions related to the infusion of Rituximab.

Eligibility Criteria

Inclusion Criteria

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

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I am 60 years old or older.

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I am using birth control as required.

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My diagnosis is mantle cell lymphoma, confirmed by a biopsy.

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I can care for myself but may not be able to do heavy physical work.

Exclusion Criteria

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

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My lymphoma is in the early stages (stage I or II).

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I have an infection that isn't responding to treatment.

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I am currently pregnant or breastfeeding.

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I need to take warfarin.

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My lymphoma has spread to my brain or spinal cord.

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I am HIV positive.

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I have a type of cancer called blastoid-variant mantle cell lymphoma.

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I need immediate treatment to reduce my cancer cells.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 240 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~240 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 240 days for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Overall response rate (ORR) after four cycles of venetoclax and rituximab.

Secondary study objectives

Proportion of CR

Proportion of PR

Proportion of disease progression

+7 more

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 and rituximab in patients over 60 yrs old with previously untreated mantle cell lymphomaExperimental Treatment1 Intervention

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.

0 / 12Eligibility criteria met