RecruitingPhase 1Phase 2NCT04855695

Avo In R/R And Previously Untreated MCL

A Phase 1/2 Study of Acalabrutinib, Venetoclax, and Obinutuzumab in Patients With Relapsed/Refractory and Previously Untreated Mantle Cell Lymphoma

Sponsor

Austin I Kim

Enrollment

72 participants

Start Date

Jul 2, 2021

Study Type

INTERVENTIONAL

Conditions

Mantle Cell Lymphoma Refractory Lymphoma

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — acalabrutinib and venetoclax with obinutuzumab — in people with mantle cell lymphoma (MCL), a type of blood cancer, either as a first treatment or after previous treatments have stopped working. **You may be eligible if...** - You have been diagnosed with mantle cell lymphoma confirmed by a biopsy - Your lymphoma has either come back or stopped responding to at least one prior treatment that included an anti-CD20 antibody (Part A), OR you have never received treatment for your lymphoma other than steroids or radiation (Part B) **You may NOT be eligible if...** - You have not had the required prior treatments (for Part A) - Your lymphoma diagnosis has not been confirmed by pathology review Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 Center

Chicago, Illinois, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

View Full Details on ClinicalTrials.gov

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NCT04855695

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