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Recruiting Phase 1/2 NCT03523975

Venetoclax, Lenalidomide and Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma

Phase 1/2 – combined early trial
Conditions: Mantle Cell Lymphoma

Sponsor: City of Hope Medical Center

trial.available_in: БГ
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).
Who can participate
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.
Interventions
Venetoclax
DRUG
Lenalidomide
DRUG
Rituximab
DRUG
Locations 4
United States (4)
University of Michigan
Ann Arbor , Michigan
University of Virginia Cancer Center
Charlottesville , Virginia
The Ohio State University Comprehensive Cancer Center
Columbus , Ohio
NOT_YET_RECRUITING
Ohio State Comprehensive Cancer Center
City of Hope Medical center
Duarte , California
Technical details
Status
Recruiting
Phase
Phase 1/2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
24.12.2018
Completion date
24.06.2027
Registry ID
NCT03523975
Source
clinicaltrials.gov
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