Recruiting
Phase 1
Phase 2

Venetoclax, Lenalidomide, Rituximab

Sponsor:

City of Hope Medical Center

Code:

NCT03523975

Conditions

Mantle Cell Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Venetoclax

Lenalidomide

Rituximab

Study Details

Brief summary:

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

Mantle Cell Lymphoma

Study ID

NCT03523975

Start date

Dec 24, 2018

Status verified date

Apr, 2026

Completion date

Jun 24, 2027

Anticipated

Primary completion date

Jun 24, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

28 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Venetoclax, Lenalidomide, Rituximab

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 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. 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.

Interventions

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.

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.

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 measure

  • Maximum Tolerated Dose (MTD) of the combination of lenalidomide, venetoclax and rituximab [ Time Frame: 42 Days ]

Central Contacts and Locations

Locations

City of Hope Medical center

Recruiting

Duarte, California, United States, 91010

Contacts

Tycel Phillips, MD

6263598111tphillips@coh.org

Principal Investigator:

Tycel Phillips, M.D.

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Dahlia Sano

734-764-8195dsano@med.umich.edu

University of Virginia Cancer Center

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

Craig Portell, MD

434-924-9637CP4YS@uvahealth.org

Principal Investigator:

Craig Portell, MD

More Information

Sponsor

City of Hope Medical Center

Last update posted

Apr 22, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by City of Hope Medical Center on 2026-04-22.