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Decitabine/Cedazuridine and Venetoclax with Ivosidenib or Enasidenib for Relapsed/Refractory AML

This study is testing combinations of medicines for acute myeloid leukemia (AML) that has come back (relapsed) or isn't responding to treatment (refractory). It's also for some older patients newly diagnosed with AML who can't have intensive chemotherapy. The study will look at how safe these combinations are and how well they work. You'll receive Decitabine/Cedazuridine (a combination drug that may block cancer cell growth), Venetoclax (which may stop cancer cell growth by blocking a protein called BCL-2), and either Ivosidenib or Enasidenib (which may stop cancer cell growth by blocking certain enzymes). The study is looking for how many patients respond to the treatment and for any side effects.

Study design
This is a Phase Ib/II interventional study with a planned enrollment of 84 participants. It is not specified if it is randomized or blinded.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study measures dose-limiting toxicity for up to one 28-day cycle, and overall response rate and adverse events within 4 months of treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04774393

Decitabine/Cedazuridine and Venetoclax in Combination With Ivosidenib or Enasidenib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia

Recruiting
PHASE1Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~84 participants
Updated 2026-05-20 on ClinicalTrials.gov
What's tested:Decitabine and CedazuridineEnasidenibIvosidenibVenetoclax

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose limiting toxicity (Phase Ib)
Measured over Up to 1 cycle (1 cycle = 28 days)
+2 more outcomes measured

Conditions

Acute Myeloid Leukemia
Recurrent Acute Myeloid Leukemia
Refractory Acute Myeloid Leukemia

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Acute Myeloid LeukemiaIDH1 GeneIDH2 Gene

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Courtney DiNardo, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Courtney DiNardo, MD
[email protected]
713-794-1141
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Patients with a diagnosis of relapsed or refractory acute myeloid leukemia (AML) (including biphenotypic or bilineage leukemia including a myeloid component or isolated extramedullary AML); OR
Patients (\> 60 year old) with newly diagnosed AML not eligible for intensive chemotherapy are also eligible
To be considered not eligible for intensive chemotherapy, participants must be defined by the following: Age 75 years or older, or Age 18 to 74 years with at least one of the following comorbidities:
Severe cardiac disorder (eg, congestive heart failure requiring treatment, ejection fraction ≤50%, or chronic stable angina).
Severe pulmonary disorder (eg, DLCO ≤65% or forced expiratory volume in 1 second \[FEV1\] ≤65%).
Creatinine clearance ≥30 mL/min to \<45 mL/min.
Moderate hepatic impairment with total bilirubin \>1.5 to ≤3.0 × upper limit of normal (ULN)
ECOG performance status of 2 or 3
Age \>= 18 years
Subjects must have documented IDH1 or IDH2 gene mutation
Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
Adequate renal function including creatinine \< 2 unless related to the disease
Direct bilirubin \< 2 x upper limit of normal (ULN) unless increase is due to Gilbert's disease or leukemic involvement
Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \< 3 x ULN unless considered due to leukemic involvement, in which case direct bilirubin or AST and/or ALT \< 5 x ULN will be considered eligible)
In the absence of rapidly proliferative disease, the interval from prior treatment to time of initiation will be at least 7 days for cytotoxic or non-cytotoxic (immunotherapy agent(s). Oral hydroxyurea and/or cytarabine (up to 2 g/m\^2) for patients with rapidly proliferative disease is allowed before the start of study therapy, as needed, for clinical benefit and after discussion with the principle investigator (PI). Concurrent therapy for central nervous system (CNS) prophylaxis or continuation of therapy for controlled CNS disease is permitted
Male subjects who are sexually active with a women of childbearing potential (WOCBP) and who have not had vasectomies must be willing to use a barrier method of contraception and refrain from sperm donation from initial study drug until 90 days after last dose of study drug
Willing and able to provide informed consent

Exclusion

Patients with t(15;17) karyotypic abnormality or acute promyelocytic leukemia (French-American-British \[FAB\] class M3-AML)
Patients with any concurrent uncontrolled clinically significant medical condition including life-threatening severe infection, or psychiatric illness, which could place the patient at unacceptable risk of study treatment
Patients with active graft-versus-host-disease (GVHD) status post stem cell transplant (patients without active GVHD on chronic suppressive immunosuppression and/or phototherapy for chronic skin GVHD are permitted after discussion with the PI)
Patients with any severe gastrointestinal or metabolic condition which could interfere with the absorption of oral study medications
Corrected QT (QTc) interval using Fridericia's formula (QTcF) \>= 450 msec. Bundle branch block and prolonged QTc interval are permitted after discussion with the PI
Known active hepatitis B (HBV) or hepatitis C (HCV) infection or known human immunodeficiency virus (HIV) infection
Subject has a white blood cell count \> 25 x 10\^9/L. (Note: Hydroxyurea is permitted to meet this criterion)
Nursing women, women of childbearing potential (WOCBP) with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception
Appropriate highly effective method(s) of contraception include oral or injectable hormonal birth control, intrauterine device (IUD), and double barrier methods (for example a condom in combination with a spermicide)

What this trial measures

  • Dose limiting toxicity (Phase Ib)Up to 1 cycle (1 cycle = 28 days)

    Will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5 by organ system.

  • Overall response rate (ORR) (Phase II)Within 4 months of treatment

    Defined as complete remission (CR), CR with incomplete hematologic recovery, CR with incomplete count recovery, partial response or marrow clearance of blasts. Will estimate the ORR for the combination treatmen1t, along with the Bayesian 95% credible interval.

  • Incidence of adverse events (Phase II)Within 4 months of treatment

    Assessed using Common Toxicity Criteria version 5.0. Safety data will be summarized using frequency and percentage, by category and severity.