Actively Recruiting
Decitabine/Cedazuridine and Venetoclax in Combination With Ivosidenib or Enasidenib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia
Led by M.D. Anderson Cancer Center · Updated on 2025-11-10
84
Participants Needed
1
Research Sites
340 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase Ib/II trials studies the side effects of decitabine/cedazuridine (ASTX727) and venetoclax in combination with ivosidenib or enasidenib, and how well they work in treating patients with acute myeloid leukemia that has come back (relapsed) or does not respond to treatment (refractory). ASTX727 is the combination of a fixed dose of 2 drugs, cedazuridine and decitabine. Cedazuridine may slow down how fast decitabine is broken down by the body, and decitabine may block abnormal cells or cancer cells from growing. Venetoclax may stop the growth of cancer cells by blocking BCL-2, a protein needed for cancer cell survival. Enasidenib and ivosidenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving decitabine/cedazuridine and venetoclax in combination with ivosidenib or enasidenib may help control acute myeloid leukemia.
CONDITIONS
Official Title
Decitabine/Cedazuridine and Venetoclax in Combination With Ivosidenib or Enasidenib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with relapsed or refractory acute myeloid leukemia, including biphenotypic or bilineage leukemia with a myeloid component or isolated extramedullary AML
- Patients older than 60 years with newly diagnosed AML not eligible for intensive chemotherapy
- Not eligible for intensive chemotherapy if age 75 or older, or age 18 to 74 with severe cardiac disorder, severe pulmonary disorder, creatinine clearance 30-<45 mL/min, moderate hepatic impairment, or ECOG performance status 2 or 3
- Age 18 years or older
- Documented IDH1 or IDH2 gene mutation
- ECOG performance status 0 to 2
- Adequate renal function with creatinine less than 2 unless related to disease
- Direct bilirubin less than 2 times upper limit of normal unless due to Gilbert's disease or leukemia
- AST and/or ALT less than 3 times upper limit of normal unless due to leukemia, then less than 5 times upper limit
- At least 7 days interval from prior treatment for cytotoxic or non-cytotoxic agents unless for rapidly proliferative disease
- Allowed hydroxyurea and/or cytarabine before study therapy for clinical benefit after investigator discussion
- Allowed concurrent therapy for CNS prophylaxis or controlled CNS disease
- Male subjects sexually active with women of childbearing potential must use barrier contraception and avoid sperm donation until 90 days after last dose
- Willing and able to provide informed consent
You will not qualify if you...
- Patients with t(15;17) karyotypic abnormality or acute promyelocytic leukemia (FAB class M3-AML)
- Patients with uncontrolled clinically significant medical conditions including severe infection or psychiatric illness
- Patients with active graft-versus-host disease post stem cell transplant (except controlled skin GVHD with immunosuppression after discussion)
- Patients with severe gastrointestinal or metabolic conditions interfering with oral medication absorption
- QTc interval corrected by Fridericia's formula 450 msec or higher (exceptions after discussion)
- Known active hepatitis B or C infection or HIV infection
- White blood cell count over 25 x 10^9/L (hydroxyurea allowed to meet this criterion)
- Nursing women, women of childbearing potential with positive pregnancy test, or those unwilling to maintain contraception according to study requirements
AI-Screening
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Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
C
Courtney DiNardo, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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