Study on Decitabine/Cedazuridine and Venetoclax with Ivosidenib or Enasidenib for Treating Relapsed or Resistant Acute Myeloid Leukemia

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04774393

Provider View

This clinical trial is testing a combination of drugs to see if they are safe and effective in treating acute myeloid leukemia (AML) that has returned or is not responding to treatment. The study involves using decitabine/cedazuridine and venetoclax with either ivosidenib or enasidenib.

Patient Parameters

Program Overview

This study is exploring the safety and effectiveness of a combination of drugs for treating acute myeloid leukemia (AML) that has come back or is not responding to treatment. The drugs being tested include decitabine/cedazuridine, which may help stop cancer cells from growing, and venetoclax, which targets a protein that cancer cells need to survive. The study also includes ivosidenib and enasidenib, which may block enzymes that help cancer cells grow. The goal is to see if these combinations can help control AML.

Description

The study is divided into two parts: Phase Ib and Phase II.

In Phase Ib, the main goal is to determine the safety and best dose of the drug combinations for patients with acute myeloid leukemia (AML). In Phase II, the study will evaluate how well the treatment works in terms of overall response, including complete response and partial response.

Secondary goals include assessing how long the response lasts, survival without events, and overall survival. The study will also look at whether the treatment can achieve minimal residual disease (MRD) negative status, which means no detectable cancer cells.

Exploratory goals involve investigating gene expression and other markers to predict treatment response or resistance.

Participants are divided into two groups:

  • Arm A: Receives decitabine/cedazuridine daily for 5 days, venetoclax daily for 14 days, and ivosidenib daily for 28 days. This cycle repeats every 28 days for up to 12 cycles, unless the disease progresses or side effects become unacceptable.
  • Arm B: Receives decitabine/cedazuridine daily for 5 days, venetoclax daily for 14 days, and enasidenib daily for 28 days. This cycle repeats every 28 days for up to 12 cycles, unless the disease progresses or side effects become unacceptable.

After completing the treatment, patients will have follow-up visits every 3 months.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with relapsed or refractory acute myeloid leukemia (AML), or newly diagnosed AML in patients over 60 who cannot have intensive chemotherapy.
  • Age 18 years or older.
  • Must have a specific gene mutation (IDH1 or IDH2).
  • Good overall health with a performance status score of 0 to 2.
  • Adequate kidney function and liver function as indicated by specific blood tests.
  • At least 7 days since last treatment for AML, unless the disease is rapidly growing.
  • Men must use contraception and avoid donating sperm during and after treatment.
  • Willing to provide informed consent.

Exclusion Criteria

  • Have a specific type of leukemia called acute promyelocytic leukemia.
  • Have uncontrolled medical conditions or severe infections.
  • Have active graft-versus-host disease after a stem cell transplant.
  • Have severe digestive or metabolic issues affecting drug absorption.
  • Have a prolonged QT interval on an ECG.
  • Have active hepatitis B, hepatitis C, or HIV infection.
  • Have a high white blood cell count (over 25 x 10^9/L).
  • Women who are pregnant, breastfeeding, or not using effective contraception.

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