Study on DEC-C and Thioguanine for Relapsed or Refractory Acute Myeloid Leukemia (AML)

Sponsor: Joseph Jurcic

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06351306

Provider View

This clinical trial is testing whether a combination of oral decitabine-cedazuridine (Inqovi®) and thioguanine (Tabloid®) is safe and effective for patients with acute myeloid leukemia (AML) that has returned or not responded to previous treatments.

Patient Parameters

Program Overview

The aim of this study is to determine if the combination of oral decitabine-cedazuridine (Inqovi®) and thioguanine (Tabloid®) can be safely used and is effective in treating patients with acute myeloid leukemia (AML) that has either come back or not responded to treatment. This is a phase II trial with a safety lead-in, meaning the initial part of the study will focus on ensuring the highest safe dose of the medications is used. If serious side effects occur, the dose may be adjusted to ensure safety.

Description

Acute myeloid leukemia (AML) is a type of cancer affecting the blood and bone marrow. It has a low survival rate, especially in older patients. Despite some progress in treatments, many patients experience a return of the disease or do not respond to standard treatments, which are limited in effectiveness. The response rate to current salvage chemotherapy is low, with a median survival of less than six months. This highlights the need for new, effective, and well-tolerated treatments.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of relapsed or refractory AML, except for acute promyelocytic leukemia.
    • Relapsed AML: Cancer has returned with at least 5% blasts in the bone marrow or leukemic blasts in the blood after a period of remission.
    • Refractory AML: Cancer did not respond to at least two courses of intensive treatment or six cycles of a specific regimen.
  • Able to provide informed consent.
  • Have a performance status score of 0 to 2 or a Karnofsky score of 60% or higher, indicating good overall health.
  • Have adequate organ function as shown by specific blood tests.
  • Previous treatment with a hypomethylating agent is allowed.
  • Women of childbearing potential must not be pregnant or nursing and must use effective contraception.
  • Men must agree to use contraception and not donate sperm during the study and for four months after.
  • Willing to provide bone marrow samples before and during the study.
  • Understand and agree to sign a written informed consent document.

Exclusion Criteria

  • Have previously received thioguanine.
  • Have had any anti-leukemic therapy within 14 days before starting the study treatment, except for hydroxyurea to control blood counts.
  • Have had a stem cell transplant within three months of joining the study or have active graft versus host disease.
  • Have active central nervous system involvement by AML, unless previously treated.
  • Have another cancer requiring treatment within six months, except for certain skin cancers or those needing only hormonal therapy.
  • Have an active, uncontrolled infection.
  • Have uncontrolled HIV.
  • Have active hepatitis B or C, unless controlled with antiviral therapy.
  • Have significant medical conditions that would make participation unsafe.
  • Have known allergies to DEC-C or thioguanine.

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