Bendamustine, Obinutuzumab, and Venetoclax in Patients With Untreated Mantle Cell Lymphoma (NCT03872180) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Bendamustine, Obinutuzumab, and Venetoclax in Patients With Untreated Mantle Cell Lymphoma
United States23 participantsStarted 2019-04-11
Plain-language summary
This phase II trial studies how well bendamustine, obinutuzumab, and venetoclax work in treating patients with mantle cell lymphoma. Drugs used in chemotherapy, such as bendamustine and venetoclax, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as obinutuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving bendamustine, obinutuzumab, and venetoclax may work better in treating patients with mantle cell lymphoma.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Signed informed consent form
* Ability and willingness to comply with the requirements of the study protocol
* Histologic diagnosis of mantle cell lymphoma. This diagnosis must be confirmed at the treating center and patients must have this diagnosis confirmed by at least one of the following criteria:
* Fluorescent in situ hybridization (FISH) or conventional cytogenetics positive for t(11;14)
* Cyclin D1 positive by immunohistochemistry
* Documentation by a hematopathologist at the treating institution that there is pathologic evidence of mantle cell lymphoma if neither criteria above are met
* No previous therapy for diagnosis of lymphoma (note that in patients deemed to be high-risk for tumor lysis syndrome or for rapid clinical deterioration due to symptomatic disease by the investigator, a short course of steroids designed to decrease tumor burden is permitted)
* Eastern Cooperative Oncology Group performance status of 0, 1, or 2
* Hemoglobin ≥ 9 g/dL
* Absolute neutrophil count ≥ 1.5 x 10⁹/L
* Platelet count ≥ 75 x 10⁹/L
* Serum creatinine ≤ 2.0 mg/dL or creatinine clearance ≥ 40 mL/min
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN)
* Total bilirubin \< 1.5 x ULN (or ≤ 3 x ULN for patients with documented Gilbert syndrome)
* NOTE: Patients with renal or hepatic impairment that is disease-related (ie, hydronephrosis, hepatic involvement) in the opinion of the investigator but who …
What they're measuring
1
Rate of Complete Response at Completion of Induction Therapy With This Combination