Oral Azacitidine for Treating Relapsed or Hard-to-Treat T-cell Large Granular Lymphocytic Leukemia

Sponsor: John Reneau

Sponsor score: 0

ClinicalTrials ID:NCT05141682

Provider View

This clinical trial is testing the safety and effectiveness of an oral medication called azacitidine for patients with T-cell large granular lymphocytic leukemia that has returned or not responded to previous treatments.

Patient Parameters

Program Overview

This study is exploring the best dose and potential benefits of oral azacitidine for patients with T-cell large granular lymphocytic leukemia (T-LGLL) that has come back or hasn't responded to other treatments. Azacitidine is a chemotherapy drug that works by stopping cancer cells from growing, dividing, or spreading.

Description

The main goals of this study are to find out how safe oral azacitidine (CC-486) is and what the highest dose patients can tolerate is. Researchers also want to see how well the drug works in reducing the cancer, either completely or partially.

Other goals include:

  • How long the response to the treatment lasts.
  • How long patients live without the cancer getting worse.
  • How many patients improve from a partial response to a complete response over time.
  • Whether the treatment clears certain cancer markers in the blood.
  • The effect of the treatment on specific genetic changes related to the cancer.

In this study, patients will take azacitidine by mouth for 14 days in a 28-day cycle. This will continue for 4 cycles unless the cancer progresses or side effects become too severe. If patients show improvement, they may continue treatment for up to 8 more cycles.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Diagnosed with T-LGLL, with specific cell markers and counts.
  • Have tried at least one previous treatment without success and have been off treatment for at least 14 days.
  • Need treatment for T-LGLL due to symptoms like low hemoglobin, dependency on blood transfusions, or low white blood cell counts leading to infections.
  • Have a platelet count of at least 50 x 10^9/L.
  • Have normal kidney and liver function based on specific blood tests.
  • Be in relatively good health with a performance status score of 2 or less.
  • Agree to use effective birth control methods during the study.
  • Able to understand and sign a consent form.

Exclusion Criteria

  • Have an active infection needing treatment.
  • Have HIV, hepatitis B, or hepatitis C.
  • Are on immune-suppressive therapy, except for low-dose prednisone for certain conditions.
  • Have another active cancer unless related to T-LGLL.
  • Have used similar drugs like 5-azacytidine or decitabine before.
  • Are pregnant or have a positive pregnancy test.

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