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Venetoclax, Lenalidomide and Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma
Sponsor: City of Hope Medical Center
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
Conditions
Interventions
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.
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.
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