Study on Venetoclax, Lenalidomide, and Rituximab for Untreated Mantle Cell Lymphoma

Sponsor: City of Hope Medical Center

Sponsor score: 40

ClinicalTrials ID:NCT03523975

This clinical trial is testing a new combination of drugs, including venetoclax, lenalidomide, and rituximab, to see if they are safe and effective for people with Mantle Cell Lymphoma (MCL) who have not received treatment before.

Patient Parameters

Program Overview

The aim of this study is to find out if a new treatment using the drugs venetoclax, lenalidomide, and rituximab is safe and works well for patients with Mantle Cell Lymphoma (MCL) who have not been treated previously. Researchers want to see if this combination can help manage the disease effectively.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of Mantle Cell Lymphoma (MCL).
  • Show signs or symptoms of MCL based on lab tests, scans, or physical exams.
  • Be in relatively good health with an ECOG performance status of 0 to 2, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Must be enrolled in the Revlimid REMS® program and agree to follow its requirements.
  • Women who can become pregnant must agree to regular pregnancy testing as part of the Revlimid REMS® program.
  • Men and women of childbearing potential must use effective birth control.
  • Have good organ function based on medical tests.
  • Be able to understand the study and agree to sign informed consent.
  • Be able to swallow pills.

Exclusion Criteria

  • Have received chemotherapy for MCL before.
  • Are pregnant or breastfeeding.
  • Have moderate to severe nerve damage.
  • Have a history of MCL affecting the brain or spinal cord.
  • Have serious heart disease.
  • Have any condition that affects how the body absorbs medication.
  • Have an uncontrolled infection or have needed IV antibiotics within two weeks before starting the study.
  • Have had a stroke or brain bleed within six months before starting the study.
  • Are participating in another clinical trial.
  • Have taken certain medications that affect drug metabolism within a week before starting the study.
  • Have mental health or social issues that would prevent following the study requirements.
  • Are HIV positive.
  • Have active Hepatitis B or C infection.
  • Have had another cancer, unless it was treated and has not returned for at least two years, or it is a type that does not affect life expectancy.

Locations

FACILITYZIPCITYSTATE
City of Hope Medical center91010DuarteCalifornia
University of Michigan48109Ann ArborMichigan
The Ohio State University Comprehensive Cancer Center43210ColumbusOhio

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