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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
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.
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.
375 mg/m2 IV day 1, 8, 15, 22 of 1st cycle then on day 1 for cycles 2, 4, 6, 8, 10, 12
City of Hope Medical center
Duarte, California, United States
RECRUITINGUniversity of Michigan
Ann Arbor, Michigan, United States
RECRUITINGThe Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Maximum Tolerated Dose (MTD) of the combination of lenalidomide, venetoclax and rituximab
Time frame: 42 Days
The proportion of patients with a Complete Response (CR)
Response will be assessed by the IRC (Immune-related Response Criteria) and the investigator on the basis of physical examinations and PET and CT scans using the Lugano 2014 criteria, taking into account results of bone marrow examinations for patients with bone marrow involvement at screening
Time frame: Up to 4 Years
The proportion of patients that respond to treatment
The proportion of patients who achieve either partial or complete response by PET, CT and marrow. Response will be assessed by the IRC and the investigator on the basis of physical examinations and PET and CT scans using the Lugano 2014 criteria, taking into account results of bone marrow examinations for patients with bone marrow involvement at screening
Time frame: Up to 4 Years
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University of Virginia Cancer Center
Charlottesville, Virginia, United States
RECRUITING