Venetoclax, Lenalidomide and Rituximab in Patients With Previously 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
City of Hope Medical Center
28 participants
Dec 24, 2018
INTERVENTIONAL
Conditions
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).
Eligibility
Inclusion Criteria10
- 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 Criteria14
- 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.
Interventions
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
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT03523975