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RECRUITING
NCT03523975
PHASE1/PHASE2

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

Sponsor: City of Hope Medical Center

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

28

Start Date

2018-12-24

Completion Date

2027-06-24

Last Updated

2026-03-13

Healthy Volunteers

No

Interventions

DRUG

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.

DRUG

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.

DRUG

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

Locations (3)

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