CI

At a glance

ClinicalIndex Comparison Record
Phase 1Recruiting· 125 target
Drug / intervention
Decitabine and Cedazuridine +4 moredrug
Likely dose
Not stated in record
Key inclusion· 7
  • Aged ≥18 years with AML in first CR or CRi
  • Not immediate candidates for allogeneic stem cell transplant
  • Received intensive cytarabine-based induction therapy with ≥1 consolidation cycle, within 2 months of last consolidation (or any time if MRD+)
  • Received lower-intensity LDAC or HMA therapy with ≥2 cycles to achieve CR/CRi (or any time if MRD+)
Key exclusion· 9
  • Diagnosis of acute promyelocytic leukemia (APL) or AML-M3 by morphology, immunophenotype, molecular, or cytogenetics
  • AML with t(15;17) or APL variant
  • t(9;22) unless unable/unwilling to receive tyrosine kinase inhibitor therapy
  • Uncontrolled intercurrent illness including active infection, symptomatic heart failure, unstable angina, arrhythmia, or psychiatric illness

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

Search/NCT05010772
NCT05010772Phase 1RecruitingOn TrackUpdated 5mo ago
Long Recruiting

Oral Decitabine-Based Maintenance Therapy in Patients With AML in Remission

M.D. Anderson Cancer Center·interventional·Posted Aug 18, 2021·Updated Jan 14, 2026

In Brief

A Phase 1 clinical trial evaluating Decitabine and Cedazuridine, Enasidenib, and 3 other interventions for Acute Myeloid Leukemia. Currently recruiting, targeting 125 participants across 1 site.

Detailed Summary

This phase Ib trial is to find out the side effects and possible benefits of decitabine alone or given together with venetoclax, gilteritinib, enasidenib, or ivosidenib in treating patients with acute myeloid leukemia that is under control (remission). Chemotherapy drugs, such as decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Venetoclax may stop the growth of cancer cells by blocking a protein called Bcl-2 needed for cell growth. Gilteritinib, enasidenib, and ivosidenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving decitabine alone or together with venetoclax, gilteritinib, enasidenib, or ivosidenib may help to control the disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 1Recruiting
202220232024202520262027
First PostedAug 18, 2021
Enrollment StartOct 25, 2021
Primary CompletionDec 31, 2026
TodayJul 1, 2026
Enrollment to primary: 5.2 yearsPosted 4.9 years agoPrimary completion in 6 months

Interventions

Decitabine and Cedazuridinedrug

Given PO

Enasidenibdrug

Given PO

Gilteritinibdrug

Given PO

Ivosidenibdrug

Given PO

Venetoclaxdrug

Given PO