RecruitingPhase 2NCT03516617

Acalabrutinib With or Without Obinutuzumab in Treating Patients With Early-Stage Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Randomized Phase 2 Study Comparing Acalabrutinib to Acalabrutinib and Obinutuzumab in the Treatment of Patients With Early-Stage Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) Who Are at High Risk of Disease Progression

Sponsor

Mayo Clinic

Enrollment

120 participants

Start Date

Sep 10, 2018

Study Type

INTERVENTIONAL

Conditions

Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma

Summary

This phase II trials studies how well acalabrutinib with or without obinutuzumab works in treating patients with early-stage chronic lymphocytic leukemia or small lymphocytic lymphoma. Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as obinutuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving acalabrutinib with or without obinutuzumab will work better in treating patients with early-stage chronic lymphocytic leukemia or small lymphocytic lymphoma.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether a targeted oral medication called acalabrutinib — used alone or combined with an antibody treatment called obinutuzumab — can effectively treat early-stage chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), both slow-growing blood cancers. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with CLL or SLL confirmed by a biopsy and specialized blood tests - You have never previously been treated for CLL or SLL with chemotherapy or antibody therapies - Your overall health is in reasonable condition (you can carry out light daily activity) - Your prognostic risk factors have been tested within the past 2 years **You may NOT be eligible if...** - You have already received chemotherapy or monoclonal antibody treatment for CLL or SLL - Your diagnosis has not been confirmed by the required testing - Your blood, liver, or kidney function is outside acceptable ranges 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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