CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 84 target
Drug / intervention
Decitabine and Cedazuridine +3 moredrug
Likely dose
Not stated in record
Key inclusion· 12
  • ✓Relapsed or refractory AML (including biphenotypic/bilineage with myeloid component or isolated extramedullary)
  • ✓Newly diagnosed AML age >60 not eligible for intensive chemotherapy
  • ✓IDH1 or IDH2 gene mutation required
  • ✓Age ≥18 years
Key exclusion· 8
  • ✕t(15;17) karyotype or acute promyelocytic leukemia (FAB M3-AML)
  • ✕Uncontrolled clinically significant medical condition, life-threatening infection, or psychiatric illness
  • ✕Active GVHD post-stem cell transplant
  • ✕Severe gastrointestinal or metabolic condition interfering with oral medication absorption

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04774393
NCT04774393Phase 2RecruitingOn Track
Long Recruiting
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Phase 1b/2 Study of Oral Decitabine/Cedazuridine (ASTX727) and Venetoclax in Combination With the Targeted Mutant IDH1 Inhibitor Ivosidenib or the Targeted Mutant IDH2 Inhibitor Enasidenib

M.D. Anderson Cancer Center·interventional·Posted Mar 1, 2021·Updated May 20, 2026

In Brief

A Phase 2 clinical trial evaluating Decitabine and Cedazuridine, Enasidenib, and 2 other interventions for Acute Myeloid Leukemia and 2 related conditions. Currently recruiting, targeting 84 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myeloid Leukemia, Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
CountriesUnited States
Collaborators--

Timeline

Phase 2Recruiting
20212022202320242025202620272028
First PostedMar 1, 2021
Enrollment StartMay 24, 2021
Primary CompletionNov 29, 2027
TodayJul 1, 2026
Enrollment to primary: 6.5 yearsPosted 5.3 years agoPrimary completion in 1.4 years

Interventions

Decitabine and Cedazuridinedrug

Given PO

Enasidenibdrug

Given PO

Ivosidenibdrug

Given PO

Venetoclaxdrug

Given PO