A Phase 1/2 Study of Acalabrutinib, Venetoclax, and Obinutuzumab in Patients With Relapsed/Refractory and Previously Untreated Mantle Cell Lymphoma
Austin I Kim
Summary
This research study is evaluating the combination of three drugs - acalabrutinib, venetoclax, and obinutuzumab - as a possible treatment for relapsed or refractory and untreated mantle cell lymphoma (MCL). The names of the study drugs involved in this study are: * Acalabrutinib * Venetoclax * Obinutuzumab
Description
This is an open-label, investigator-initiated, single-arm, multi-cohort phase 1/2 study to assess the safety and efficacy of the combination of acalabrutinib, venetoclax, and obinutuzumab (AVO) in relapsed/refractory (R/R) and untreated mantle cell lymphoma (MCL). The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. The names of the study drugs involved in this study are: * Acalabrutinib * Venetoclax * Obinutuzumab Participants will receive study treatment for as long as there are no serious side effects and the dis…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participants must meet the following criteria on screening examination to be eligible to participate in the study: * Participants must have histologically determined mantle cell lymphoma with pathologic review at the participating institutions, that has either: * Relapsed or primary refractory after at least one line of therapy including anti-CD20 monoclonal antibody treatment (part A) or; Had no previous anti-lymphoma therapy other than corticosteroids or radiotherapy (parts B, C, and D). * Participants in part A, relapsed or refractory following prior therapy, may…
Interventions
- DrugAcalabrutinib
Each study drug is given according to a different schedule: Acalabrutinib: Oral, dosage per protocol, start cycle 1 and beyond according to schedule outlined in protocol
- DrugVenetoclax
Venetoclax: oral. daily, dosage per protocol, start cycle 3 and beyond according to schedule outlined in protocol
- DrugObinutuzumab
Obinutuzumab: intravenous infusion, dosage per protocol, drug during cycles 2 and beyond according to schedule outlined in protocol
Locations (3)
- University of Chicago Medical CenterChicago, Illinois
- Beth Israel Deaconess Medical CenterBoston, Massachusetts
- Dana-Farber Cancer InstituteBoston, Massachusetts