Study on Acalabrutinib and Venetoclax With or Without Early Obinutuzumab for Treating High Risk, Recurrent, or Resistant Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04169737

Provider View

This clinical trial is exploring how well a combination of drugs, acalabrutinib and venetoclax, with or without the early addition of obinutuzumab, works for treating chronic lymphocytic leukemia or small lymphocytic lymphoma that is high risk, has returned, or does not respond to treatment.

Patient Parameters

Program Overview

The study aims to find out if using acalabrutinib and venetoclax, with or without early obinutuzumab, can effectively treat chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that is high risk, has come back, or is resistant to treatment. Acalabrutinib and venetoclax work by blocking proteins that help cancer cells grow, while obinutuzumab is an immunotherapy that helps the immune system attack cancer cells. The combination may improve treatment outcomes and control the disease.

Description

The main goal of this study is to see if adding early obinutuzumab to acalabrutinib and venetoclax can improve the treatment results for patients with CLL or SLL. Researchers will look at how many patients have no detectable cancer in their bone marrow after treatment. They will also assess the safety of the drug combination and how well patients respond to it.

Patients will be divided into two groups. In one group, patients will take acalabrutinib and venetoclax, and if needed, receive obinutuzumab later in the treatment. In the other group, patients will start with obinutuzumab along with acalabrutinib and venetoclax. The treatment will last up to 26 cycles, with each cycle being 28 days long, unless there are side effects or the disease progresses.

After finishing the treatment, patients will have regular follow-up visits to monitor their health and the effectiveness of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) and need treatment based on specific medical criteria.
  • For untreated patients: Must have at least one high-risk feature or be 65 years or older.
  • For patients who have had treatment before: Must have relapsed or not responded to at least one prior therapy.
  • Be 18 years or older.
  • Have a performance status score of 2 or less, indicating good overall health.
  • Have adequate kidney and liver function based on specific blood tests.
  • Have sufficient blood cell counts, unless low counts are due to cancer in the bone marrow.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for a specified time after treatment.
  • Men must agree to use effective contraception during the study and for a specified time after treatment.
  • Free of other cancers for 2 years, with some exceptions for certain skin and cervical cancers.
  • Must provide written informed consent to participate in the study.

Exclusion Criteria

  • Previously treated with both BTK and BCL2 inhibitors without achieving a partial response or needing new treatment within 2 years.
  • Recent major surgery, radiation, chemotherapy, or other treatments within 3 weeks before starting the study drugs.
  • Severe allergic reactions to similar drugs.
  • Uncontrolled active infections.
  • Positive for HIV due to potential drug interactions.
  • Active hepatitis B or C infections.
  • Uncontrolled autoimmune conditions requiring high-dose steroids.
  • Significant heart disease or recent heart attack.
  • Pregnant or breastfeeding women.
  • Taking warfarin or certain other medications that interact with the study drugs.
  • Consumed grapefruit or similar fruits within 7 days of starting venetoclax.
  • History of bleeding disorders or recent stroke.
  • Conditions that prevent taking oral medications.
  • Other severe medical or psychiatric conditions that may interfere with the study.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.