Bendamustine, Obinutuzumab, and Venetoclax in Patients With Untreated Mantle Cell Lymphoma
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- CCND1 Positive
- Mantle Cell Lymphoma
- t(11;14) Positive
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVE: I. To evaluate the efficacy of the combination of bendamustine, obinutuzumab and venetoclax in patients with untreated mantle cell lymphoma. SECONDARY OBJECTIVES: I. To evaluate the safety and dose intensity of the combination of bendamustine, obinutuzumab and venetoclax in untrea...
PRIMARY OBJECTIVE: I. To evaluate the efficacy of the combination of bendamustine, obinutuzumab and venetoclax in patients with untreated mantle cell lymphoma. SECONDARY OBJECTIVES: I. To evaluate the safety and dose intensity of the combination of bendamustine, obinutuzumab and venetoclax in untreated mantle cell lymphoma. II. To explore methods of determining molecular remission for patients with untreated mantle cell lymphoma (MCL). III. To evaluate long-term outcomes including progression-free and overall survival for patients with untreated MCL who receive the combination. OUTLINE: Patients receive venetoclax orally (PO) on days 1-28 of course 1 and days 1-10 of subsequent courses, bendamustine intravenously (IV) on days 1 and 2, and obinutuzumab IV on days 1, 8, and 15 of course 1 and day 1 of subsequent courses. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unaccepted toxicity. After completion of study treatment, patients are followed up at 45-60 days.
Tracking Information
- NCT #
- NCT03872180
- Collaborators
- Genentech, Inc.
- Investigators
- Principal Investigator: Jonathon B. Cohen, MD, MS Emory University