RecruitingPhase 2NCT05336812

Acalabrutinib in Combination With Venetoclax or Obinutuzumab for the Treatment of Treatment-naive Chronic Lymphocytic Leukemia

Prospective Randomized Phase II Study of Acalabrutinib + Obinutuzumab or Venetoclax in Previously Untreated CLL


Sponsor

Ohio State University Comprehensive Cancer Center

Enrollment

52 participants

Start Date

Sep 13, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial tests whether acalabrutinib in combination with venetoclax or obinutuzumab works to shrink tumors in patients with treatment-naive chronic lymphocytic leukemia . Acalabrutinib is also an inhibitor that works in the body to block the activation of certain cells that lead to the growth of cancerous B cells. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Obinutuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Giving acalabrutinib in combination with venetoclax or obinutuzumab may help ease symptoms, decrease the amount of cancer suggestive of improvement, prolonged disease-free remission and/or survival, and increased knowledge about cancer treatment in patients with chronic lymphocytic leukemia. Patients will be treated with acalabrutinib for 12 cycles, and then randomized to receive 6 cycles of acalabrutinib plus obinutuzumab or acalabrutinib plus venetoclax.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of targeted cancer drugs — acalabrutinib with either venetoclax or obinutuzumab — as an initial treatment for people with chronic lymphocytic leukemia (CLL) who have never received treatment before. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with CLL or small lymphocytic lymphoma (SLL) - You have never received chemotherapy, immunotherapy, or targeted therapy for CLL - Your disease has reached a stage where treatment is needed (e.g., worsening anemia, low platelets, enlarged lymph nodes, rapid disease progression) **You may NOT be eligible if...** - You have already been treated for CLL with any systemic therapy - Your blood counts, liver, or kidney function do not meet the required levels - You have certain heart conditions or take blood thinners that could cause problems 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

Given PO

BIOLOGICALObinutuzumab

Given IV

DRUGVenetoclax

Given PO


Locations(1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

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NCT05336812


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