Study on Acalabrutinib and Obinutuzumab for Treating Chronic Lymphocytic Leukemia

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04505254

Provider View

This clinical trial is exploring how well the combination of acalabrutinib and obinutuzumab works in treating patients with chronic lymphocytic leukemia (CLL) who have not yet received treatment. The study aims to see if these drugs can help control the disease by stopping cancer cell growth and boosting the immune system.

Patient Parameters

Program Overview

This phase II study is testing the effectiveness of two drugs, acalabrutinib and obinutuzumab, in treating patients with chronic lymphocytic leukemia (CLL) who have not been treated before. Acalabrutinib works by blocking certain enzymes that cancer cells need to grow, while obinutuzumab is an immunotherapy that may help the immune system fight cancer cells. The goal is to see if this combination can help control the progression of CLL.

Description

The main goal of this study is to find out how many patients can remain in remission, without needing further treatment, six months after stopping acalabrutinib and obinutuzumab. Researchers also want to identify factors that help patients stay in remission for more than six months and to see how effective the treatment is if the disease returns.

Patients will take acalabrutinib pills twice a day and receive obinutuzumab through an IV on specific days. If patients do not achieve full remission after eight cycles, they may continue with acalabrutinib alone for up to six more cycles. Those with partial response or stable disease may receive an additional six cycles of both drugs. Treatment cycles repeat every 28 days for up to 24 cycles unless the disease progresses or side effects become unacceptable.

After finishing the treatment, patients will have follow-up visits 30 days later and then every three months to monitor their health.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) and have not received any treatment.
  • Must meet specific criteria for needing treatment based on international guidelines.
  • Have a performance status score of 0 to 2, indicating good overall health.
  • Women of childbearing potential must agree to use effective birth control during treatment and for a specified period after the last dose of the study drugs.
  • Must have a negative pregnancy test before starting treatment.
  • Have adequate kidney and liver function as shown by specific blood tests.
  • Must not have had any other cancers in the past two years, except for certain skin or cervical cancers that are not considered serious.

Exclusion Criteria

  • Pregnant or breastfeeding women.
  • Have received any prior treatment for CLL/SLL.
  • Have a known history of HIV or any uncontrolled active infections.
  • Have active hepatitis B or C infections.
  • Have uncontrolled autoimmune blood disorders.
  • Have severe blood cell deficiencies not related to the disease.
  • Have significant heart disease or recent heart attacks.
  • Have had a stroke or brain bleeding in the past six months.
  • Have a history of bleeding disorders.
  • Have had major surgery or significant injuries recently.
  • Are taking certain blood thinners or have difficulty swallowing pills.
  • Have known allergies to the study drugs.
  • Are taking medications that strongly affect liver enzymes.
  • Are participating in another clinical trial.

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