Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT03523975

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

Led by City of Hope Medical Center · Updated on 2026-04-22

28

Participants Needed

4

Research Sites

443 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Diagnosis of mantle cell lymphoma established by tissue examination
  • Signs, symptoms, or test results related to mantle cell lymphoma
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  • Enrollment in and willingness to comply with the Revlimid REMS® safety program
  • Females of childbearing potential must follow scheduled pregnancy tests
  • Men and women of childbearing potential must use effective contraception
  • Adequate organ function as determined by study requirements
  • Ability to understand and sign informed consent
  • Ability to swallow oral capsules or tablets
Not Eligible

You will not qualify if you...

  • Prior chemotherapy treatment for mantle cell lymphoma
  • Pregnant or breastfeeding women
  • Peripheral neuropathy of grade 2 or higher
  • Known history of central nervous system or leptomeningeal involvement by mantle cell lymphoma
  • Significant cardiovascular disease
  • Conditions that may impair drug absorption
  • Uncontrolled active infection or recent use of intravenous anti-infective treatment within 2 weeks
  • History of stroke or brain bleeding within 6 months
  • Participation in another clinical trial at the same time
  • Use of moderate or strong CYP3A inhibitors or inducers within 1 week prior to treatment
  • Psychiatric or social conditions limiting study compliance
  • Known HIV positivity
  • Active hepatitis B or C infection with detectable viral load
  • Prior cancers except certain treated skin or cervical cancers or cancers disease-free for at least 2 years

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

City of Hope Medical center

Duarte, California, United States, 91010

Actively Recruiting

2

University of Michigan

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

3

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States, 43210

Not Yet Recruiting

4

University of Virginia Cancer Center

Charlottesville, Virginia, United States, 22903

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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