RecruitingPhase 1Phase 2NCT03523975

Venetoclax, Lenalidomide and Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma

Phase I/II Multi-site Study Evaluating the MTD, Safety and Efficacy of the Combination Venetoclax, Lenalidomide and Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma


Sponsor

City of Hope Medical Center

Enrollment

28 participants

Start Date

Dec 24, 2018

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to determine if giving an experimental drug called venetoclax in combination with lenalidomide and rituximab is safe and effective for treating people with Mantle Cell Lymphoma (MCL).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying a combination of three drugs — venetoclax, lenalidomide, and rituximab — as a first treatment for mantle cell lymphoma, a type of blood cancer, to see if this combination can produce longer-lasting remissions without the need for stem cell transplant. **You may be eligible if...** - You are 18 years or older - You have been newly diagnosed with mantle cell lymphoma (confirmed by biopsy) - You have not received any prior chemotherapy or antibody treatments for mantle cell lymphoma - Your general health allows you to be somewhat active (ECOG score 0–2) - You are willing and able to participate in a mandatory drug safety monitoring program (called Revlimid REMS) - You can swallow oral capsules and tablets - You are using appropriate contraception if you are of childbearing age **You may NOT be eligible if...** - You have already been treated with chemotherapy for mantle cell lymphoma - You are pregnant or breastfeeding - You have significant nerve damage (grade 2 or higher), heart disease, or an active infection - The cancer has spread to the brain or spinal fluid - You have a condition that prevents proper absorption of oral medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVenetoclax

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.

DRUGLenalidomide

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.

DRUGRituximab

375 mg/m2 IV day 1, 8, 15, 22 of 1st cycle then on day 1 for cycles 2, 4, 6, 8, 10, 12


Locations(4)

City of Hope Medical center

Duarte, California, United States

University of Michigan

Ann Arbor, Michigan, United States

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

University of Virginia Cancer Center

Charlottesville, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT03523975


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