Study on Acalabrutinib for Treating Autoimmune Hemolytic Anemia in Patients with Chronic Lymphocytic Leukemia

Sponsor: City of Hope Medical Center

Sponsor score: 40

ClinicalTrials ID:NCT04657094

Provider View

This clinical trial is testing the drug acalabrutinib to see if it can help treat autoimmune hemolytic anemia in patients with chronic lymphocytic leukemia, especially when the condition has returned or hasn't responded to previous treatments.

Patient Parameters

Program Overview

This study is exploring the effects of acalabrutinib, a medication that may help stop cancer cells from growing, in patients with chronic lymphocytic leukemia (CLL) who have autoimmune hemolytic anemia (AIHA) that has either come back or not responded to other treatments. The trial aims to see if acalabrutinib can improve hemoglobin levels and assess its safety and effectiveness.

Description

The main goal of this study is to see how well acalabrutinib works in patients with chronic lymphocytic leukemia (CLL) who have autoimmune hemolytic anemia (AIHA) that has returned or not responded to previous treatments. Researchers will also look at how acalabrutinib affects hemoglobin levels in the short and long term, its safety, and its overall effectiveness in treating CLL. Additionally, the study will explore how acalabrutinib impacts T-cell function in autoimmune disorders.

Participants will take acalabrutinib by mouth twice a day for 28-day cycles, up to 12 cycles, unless the disease progresses or side effects become unacceptable. Treatment may continue for up to 36 cycles if the doctor believes it could still be beneficial. After finishing the treatment, participants will have follow-up visits 30 days later and every 4 months for up to a year.

Eligibility Criteria

Inclusion Criteria

  • Must provide informed consent to participate.
  • Agree to allow the use of previous tumor biopsy samples, if available.
  • Have a performance status score of 0 to 2, indicating full activity or some restriction in strenuous activities.
  • Have autoimmune hemolytic anemia (AIHA) related to chronic lymphocytic leukemia (CLL) that has returned or not responded to first-line treatment.
  • Show laboratory evidence of hemolysis, such as increased reticulocyte count and other markers.
  • Have a positive direct antiglobulin test (DAT).
  • Have a confirmed diagnosis of CLL or small lymphocytic lymphoma (SLL).
  • Be able to swallow tablets or capsules.
  • Have adequate blood cell counts and organ function as determined by specific tests.
  • Test negative for HIV, hepatitis B, hepatitis C, and syphilis.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for 2 days after the last dose.

Exclusion Criteria

  • Have received certain cancer treatments recently, such as therapeutic antibodies or specific targeted therapies.
  • Have had a stem cell transplant within the past year or are on ongoing immunosuppressive therapy.
  • Are taking strong CYP3A4 inducers/inhibitors or proton pump inhibitors.
  • Have a history of bleeding disorders or active bleeding.
  • Have uncontrolled infections or a history of certain viral infections.
  • Have had major surgery recently or have difficulty swallowing oral medication.
  • Have significant heart disease or psychiatric conditions that could interfere with the study.
  • Are pregnant, breastfeeding, or planning to conceive during the study.
  • Have any other condition that the investigator believes would make participation unsafe.

Locations

FACILITYZIPCITYSTATE
City of Hope Medical Center91010DuarteCalifornia

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