RecruitingPhase 2NCT04505254

Acalabrutinib and Obinutuzumab for the Treatment of Chronic Lymphocytic Leukemia

Intermittent Therapy With the BTK Inhibitor Acalabrutinib (Calquence) in Combination With Obinutuzumab in Treatment Naive (Tn) Patients With Chronic Lymphocytic Leukemia (CLL)

Sponsor

M.D. Anderson Cancer Center

Enrollment

60 participants

Start Date

Aug 25, 2020

Study Type

INTERVENTIONAL

Conditions

Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma

Summary

This phase II trial investigates the how well acalabrutinib and obinutuzumab work in treating patients with chronic lymphocytic leukemia (CLL). Acalabrutinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with obinutuzumab may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving acalabrutinib and obinutuzumab may help to control disease progression in CLL patients who have not received treatment for CLL.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests acalabrutinib combined with obinutuzumab — two targeted drugs — as a first-line treatment for chronic lymphocytic leukemia (CLL), a type of slow-growing blood cancer. Neither drug is traditional chemotherapy. **You may be eligible if...** - You have been diagnosed with CLL or small lymphocytic lymphoma (SLL) and have NOT yet received treatment - Your CLL meets recognized criteria indicating that treatment is needed - You are in adequate overall health (ECOG performance status 0–2) - You are willing to use effective birth control during treatment if applicable **You may NOT be eligible if...** - You have already received treatment for CLL - You have serious heart rhythm problems - You are on blood thinners that cannot be safely managed during the study - You are pregnant or breastfeeding 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

Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

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NCT04505254

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