Combination treatment for 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
This study is testing a new combination of three drugs to see if it can help adults with untreated Mantle Cell Lymphoma feel better and respond well compared to standard treatments.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | City of Hope Medical Center Academic / other |
| Drugs / interventions | chemotherapy, rituximab |
| Locations | 4 sites (Duarte, California and 3 other locations) |
| Trial ID | NCT03523975 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of an experimental treatment combining venetoclax, lenalidomide, and rituximab for patients diagnosed with Mantle Cell Lymphoma (MCL). Participants must be at least 18 years old and have a confirmed diagnosis of MCL, with specific health criteria to ensure eligibility. The study aims to assess how well this combination therapy works compared to standard treatments. It involves monitoring participants for side effects and overall response to the treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of Mantle Cell Lymphoma and adequate organ function.
Not a fit: Patients with severe comorbidities or those who have previously received treatment for Mantle Cell Lymphoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with previously untreated Mantle Cell Lymphoma.
How similar studies have performed: Other studies have shown promising results with similar combination therapies in treating various types of lymphoma, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * Prior treatment for MCL with chemotherapy * Pregnant or breastfeeding women * Grade 2 or higher peripheral neuropathy * Known history of CNS (Central Nervous System) or leptomeningeal by MCL prior to study enrollment * Significant cardiovascular disease * Any condition that might significantly impair drug absorption as determined by the investigator * Uncontrolled active systemic fungal, bacterial, viral, or other infection, or intravenous anti-infective treatment within 2 weeks before first dose of study drug * History of stroke or intracranial hemorrhage within 6 months of 1st 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. * 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.
Where this trial is running
Duarte, California and 3 other locations
- City of Hope Medical center — Duarte, California, United States (Recruiting)
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
- The Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States (Not_yet_recruiting)
- University of Virginia Cancer Center — Charlottesville, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Tycel Phillips, M.D. — City of Hope Medical Center
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.