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Acalabrutinib, Venetoclax, and Obinutuzumab for Initial Therapy of CLL

NCT03580928 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2026-02-13

Study results available
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Summary

This research study is evaluating the combination of three drugs - acalabrutinib, venetoclax, and obinutuzumab -- as a possible treatment for chronic lymphocytic leukemia (CLL).

The drugs involved in this study are:

* Acalabrutinib
* Venetoclax
* Obinutuzmab

Conditions

  • Chronic Lymphocytic Leukemia (CLL)

Interventions

DRUG

Venetoclax

Venetoclax is an oral drug that blocks the function of a protein called BCL-2. CLL cancer cells are thought to depend on the BCL-2 protein for their survival. By blocking BCL-2, venetoclax may kill cancer cells or stop them from growing.

DRUG

Obinutuzumab

Obinutuzumab is a type of drug called a monoclonal antibody. It targets a protein CD20 on the surface of the CLL cell, causing it to die

DRUG

Acalabrutinib

Acalabrutinib is a type of drug called a kinase inhibitor. It blocks a type of protein called Bruton Tyrosine Kinase (BTK) that helps CLL cells live and grow

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Genentech, Inc.

    collaborator INDUSTRY

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Cancer Institute (NCI)

    collaborator NIH

  • Dana-Farber Cancer Institute

    lead OTHER

Principal Investigators

  • Matthew S. Davids, MD, MMSc · Dana-Farber Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-07
Primary Completion
2024-04-10
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03580928 on ClinicalTrials.gov