NCT04855695

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Austin I Kim · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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 disease does not get worse. Participants will be followed for 5 years. It is expected that 72 people will take part in this research study. This is a Phase I/II clinical trial. Phase I clinical trials test the safety of investigational drugs and also tries to define the appropriate dose of investigational drugs to use for further studies. "Investigational" means that the drugs are being studied. * The U.S. Food and Drug Administration (FDA) has not approved venetoclax and obinutuzumab for this specific disease but it has been approved for other uses. * The U.S. Food and Drug Administration (FDA) has approved acalabrutinib as a treatment option for this disease.

Conditions

• Mantle Cell Lymphoma
• Refractory Lymphoma

Interventions

Type	Name	Description
DRUG	Acalabrutinib	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
DRUG	Venetoclax	Venetoclax: oral. daily, dosage per protocol, start cycle 3 and beyond according to schedule outlined in protocol
DRUG	Obinutuzumab	Obinutuzumab: intravenous infusion, dosage per protocol, drug during cycles 2 and beyond according to schedule outlined in protocol

Timeline

• Start date: 2021-07-02
• Primary completion: 2027-06-30
• Completion: 2027-12-31
• First posted: 2021-04-22
• Last updated: 2026-01-21

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study