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

NCT03523975 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: 19335HUM00140979
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD) of the combination of lenalidomide, venetoclax and rituximab

  42 Days

Secondary Outcomes (2)

• The proportion of patients with a Complete Response (CR)

  Up to 4 Years

• The proportion of patients that respond to treatment

  Up to 4 Years

Study Arms (1)

Venetoclax, Lenalidomide, Rituximab

EXPERIMENTAL

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.

Drug: Venetoclax; Drug: Lenalidomide; Drug: Rituximab

Interventions

Venetoclax DRUG

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.

Venetoclax, Lenalidomide, Rituximab

Lenalidomide DRUG

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, Lenalidomide, Rituximab

Rituximab DRUG

375 mg/m2 IV day 1, 8, 15, 22 of 1st cycle then on day 1 for cycles 2, 4, 6, 8, 10, 12

Venetoclax, Lenalidomide, Rituximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• City of Hope Medical Center: lead

Study Sites (4)

City of Hope Medical center

Duarte, California, 91010, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

NOT YET RECRUITING

University of Virginia Cancer Center

Charlottesville, Virginia, 22903, United States

RECRUITING

Related Publications (1)

• Phillips TJ, Bond D, Takiar R, Kump K, Kandarpa M, Boonstra P, Mayer TL, Nachar V, Wilcox RA, Carty SA, Karimi YH, Nikolovska-Coleska Z, Kaminski MS, Herrera AF, Maddocks K, Popplewell L, Danilov AV. Adding venetoclax to lenalidomide and rituximab is safe and effective in patients with untreated mantle cell lymphoma. Blood Adv. 2023 Aug 22;7(16):4518-4527. doi: 10.1182/bloodadvances.2023009992.

  PMID: 37013954 DERIVED

MeSH Terms

Conditions

Lymphoma, Mantle-Cell

Interventions

venetoclax; Lenalidomide; Rituximab

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Tycel Phillips, M.D.

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2018
• First Posted: May 14, 2018
• Study Start: December 24, 2018
• Primary Completion (Estimated): June 24, 2027
• Study Completion (Estimated): June 24, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

US (4)