Phase II Study of Bendamustine and Rituximab Plus Venetoclax in Untreated Mantle Cell Lymphoma Ov… (NCT03834688) | Clinical Trial Compass
CompletedPhase 2
Phase II Study of Bendamustine and Rituximab Plus Venetoclax in Untreated Mantle Cell Lymphoma Over 60 Years of Age
United States33 participantsStarted 2020-01-13
Plain-language summary
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.
Who can participate
Age range60 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 potenti…
What they're measuring
1
Complete Response (CR) Rate at End of Induction
Timeframe: Complete Response (CR) status was assessed after 6 months of induction treatment, plus an additional 2 months for end of treatment PET/CT scans.