Tests venetoclax, lenalidomide and rituximab in mantle cell lymphoma
Tests a drug combination for people newly diagnosed with mantle cell lymphoma.
Plain-language title generated from the registry record
Registry title: Venetoclax, Lenalidomide and Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma
Key facts
- Where
- Ann Arbor, Charlottesville, Columbus, and Duarte, United StatesSee the 4 sites
- Phase
- Phase 1/2
Where in United States
- University of MichiganAnn Arbor, United StatesTaking people
- University of Virginia Cancer CenterCharlottesville, United StatesTaking people
- The Ohio State University Comprehensive Cancer CenterColumbus, United StatesNot yet recruiting
- City of Hope Medical CenterDuarte, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- City of Hope Medical Center
- Trial code
- NCT03523975
- Record updated
- 14 October 2026
- Original description
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).Read full original descriptionShow less
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
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).
Inclusion: Age ≥18 years; Diagnosis of mantle cell lymphoma (MCL) established by histologic assessment; Laboratory, radiographic, physical exam findings and/or symptoms attributable to MCL; ECOG Performance Status (Eastern Cooperative Oncology Group Performance Status: an attempt to quantify cancer patients' general well-being and activities of daily life. The score ranges from 0 to 5 where 0 is asymptomatic and 5 is death) less or equal to 2; All study participants must be registered into the mandatory Revlimid REMS® program, and be willing and able to comply with the requirements of the REMS® program; Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program; Men and Women of childbearing potential on appropriate contraception; Adequate organ function; Ability to understand and the willingness to sign a written informed consent; Ability to swallow oral capsules/tablets.
Exclusion: Prior treatment for MCL with chemotherapy; Known history of CNS (Central Nervous System) or leptomeningeal by MCL prior to study enrollment; Uncontrolled active systemic fungal, bacterial, viral, or other infection, or intravenous anti-infective treatment within 2 weeks before first dose of study drug; Concurrent participation in another clinical trial; Subject has received a moderate or strong CYP3A inhibitor or inducer within 1 week prior to treatment initiation; Significant cardiovascular disease; Any condition that might significantly impair drug absorption as determined by the investigator; History of stroke or intracranial hemorrhage within 6 months of 1st dose of study drug; Psychiatric illness or social situations that would limit compliance with study requirements; Subject has known positivity to HIV; Active infection with Hepatitis B or C virus as determined by a detectable viral load on PCR; Prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or any other cancer from which the subject has been disease free for ≥ 2 years or which will not limit survival to< 2 years; Pregnant or breastfeeding women; Grade 2 or higher peripheral neuropathy.