Recruiting NCT03523975
Venetoclax, Lenalidomide and Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Venetoclax, Lenalidomide, Rituximab.
- Who it may be relevant to
- Registry conditions: Mantle Cell Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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).
Interventions
- Drug 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. - Drug 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. - Drug 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
Primary outcome measures
- Maximum Tolerated Dose (MTD) of the combination of lenalidomide, venetoclax and rituximab [Time frame: 42 Days]
Secondary outcome measures (2)
- The proportion of patients with a Complete Response (CR) [Time frame: Up to 4 Years]
- The proportion of patients that respond to treatment [Time frame: Up to 4 Years]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 4 centers
- City of Hope Medical center — Duarte
- University of Michigan — Ann Arbor
- The Ohio State University Comprehensive Cancer Center — Columbus
- University of Virginia Cancer Center — Charlottesville
Publications
- Phillips TJ, Bond D, Takiar R, Kump K, Kandarpa M, Boonstra P, Mayer TL, Nachar V, Wilcox RA, Carty SA, Karimi YH, Nikolovska-Coleska Z, Kaminski MS, Herrera AF, Maddocks K, Popplewell L, Danilov AV. Adding venetoclax to lenalidomide and rituximab is safe and effective in patients with untreated mantle cell lymphoma. Blood Adv. 2023 Aug 22;7(16):4518-4527. doi: 10.1182/bloodadvances.2023009992. PMID 37013954
Identifiers
NCT: NCT03523975 · 19335 · HUM00140979