Phase II Study of Bendamustine and Rituximab Plus Venetoclax in Untreated Mantle Cell Lymphoma Over 60 Years of Age

Completed · Phase 2

Conditions studied: Mantle Cell Lymphoma

In brief

Eligible untreated patients will receive single arm venetoclax, bendamustine and rituximab as induction therapy. After 6 cycles, maintenance rituximab may be administered per physician discretion. Venetoclax is an oral Bcl-2 family protein inhibitor. It targets the B-cell lymphoma 2 (BCL-2) protein, which supports cancer cell growth and is overexpressed in many patients with mantle cell lymphoma. Venetoclax may make the cancer cells sensitive to chemotherapy. This may help to slow down the growth of cancer or may cause cancer cells to die. The purpose of this study is to see if venetoclax in combination with bendamustine and rituximab chemotherapy is effective in treating people who have mantle cell lymphoma and to examine the side effects, good and bad, associated with this combination.

Key facts

Study ID: NCT03834688
Run by: PrECOG, LLC.
People needed: 33
Starts: 2020-01-13
Expected to finish: 2024-07-26
Last updated by the study team: 2025-08-11

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients must have histologically confirmed (biopsy-proven) diagnosis of mantle cell lymphoma (MCL), with documented cyclin D1 (BCL1) expression by immunohistochemical stains and/or t(11;14) by cytogenetics or Fluorescence In Situ Hybridization (FISH).
Patients must have measurable or evaluable disease as defined as a lymph node measuring >1.5 cm in any dimension or splenomegaly with spleen >15 cm in craniocaudal dimension.
Age ≥ 60 years.
No intention to undergo consolidation with high dose chemotherapy and autologous stem cell rescue (Autologous Stem Cell Transplant) in first remission.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Ability to understand and willingness to sign Institutional Review Board (IRB)-approved informed consent.
Willing to provide mandatory tissue samples (if sufficient tissue available), bone marrow and blood samples for research purposes.
Adequate organ function as measured by the following criteria, obtained ≤ 2 weeks prior to registration:
Absolute Neutrophil Count (ANC) ≥ 1000/mm³
Hemoglobin ≥ 8 g/dL
Platelets ˃75,000/mm³
Creatinine clearance ≥ 40 mL/min, calculated with the use of 24-hour creatinine clearance or by Cockcroft-Gault formula
Total Bilirubin ≤ 1.5x Upper Limit of Normal (ULN) or ≤ 3x ULN for patients with documented Gilbert's syndrome
Aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) ≤ 2.5x ULN
All females of childbearing potential (not surgically sterilized and between menarche and 1 year post menopause) must have a blood test to rule out pregnancy within 2 weeks prior to registration.
Women must not be pregnant or breastfeeding. Females of childbearing potential who are sexually active with a non-sterilized male partner and sexually active men must agree to use 2 methods of adequate contraception (hormonal plus barrier or 2 barrier forms) prior to study entry, for the duration of study participation, and for 12 months after last dose of therapy. Method of contraception must be documented.
Patients should not have prior chemotherapy, radiotherapy or immunotherapy for lymphoma.
Patients must have no recent (<1 year) history of malignancy except for the following:
adequately treated non-melanoma skin cancer
adequately treated Stage I melanoma of the skin
in situ cervical cancer
low grade prostate adenocarcinoma (Gleason grade ≤ 6) managed with observation and stable for 6 months.
Patients should not have known evidence of central nervous system (CNS) lymphoma.
Patients must not have received a prior allogeneic stem cell transplant or solid organ transplant (except for cornea) for any indication.
Patients must have no active, uncontrolled infections.

Where it is running

Carle Cancer Center — Urbana, Illinois, United States
Indiana University Simon Cancer Center — Indianapolis, Indiana, United States
St. Joseph Mercy Hospital Cancer Care Center — Ann Arbor, Michigan, United States
Mayo Clinic — Rochester, Minnesota, United States
Washington University School of Medicine Siteman Cancer Center — St Louis, Missouri, United States
Penn State Cancer Institute — Hershey, Pennsylvania, United States
University of Virginia Health System — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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