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Recruiting Phase 1, Phase 2 NCT04855695

Avo In R/R And Previously Untreated MCL

Trial Parameters

Condition Mantle Cell Lymphoma
Sponsor Austin I Kim
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 72
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2021-07-02
Completion 2027-06-30
Interventions
AcalabrutinibVenetoclaxObinutuzumab

Brief 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

Eligibility Criteria

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 have had a prior autologous or allogeneic stem cell transplant and may have been treated with chimeric antigen receptor T-cells (CAR T-cells). * Participants in parts B, C, and D, without prior anti-lymphoma therapy, must require treatment as defined by any of the following criteria: * Symptomatic adenopathy or splenomegaly * Local symptoms due to extranodal disease * Organ function impairment due to d

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