RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

Phase I Multi-site Study Evaluating the MTD, Safety and Efficacy of the Combination Venetoclax, Lenalidomide and Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma

Quick Facts

Study Start:2018-12-24

Study Completion:2027-06-24

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03523975

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Principal Investigator

Tycel Phillips, M.D.

PRINCIPAL_INVESTIGATOR

City of Hope Medical Center

Study Locations (Sites)

City of Hope Medical center

Duarte, California, 91010

United States

University of Michigan

Ann Arbor, Michigan, 48109

United States

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210

United States

Collaborators and Investigators

Sponsor: City of Hope Medical Center

Tycel Phillips, M.D., PRINCIPAL_INVESTIGATOR, City of Hope Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-12-24

Study Completion Date2027-06-24

Study Record Updates

Study Start Date2018-12-24

Study Completion Date2027-06-24

Terms related to this study

Additional Relevant MeSH Terms

Mantle Cell Lymphoma