Post-transplantation Maintenance Therapy With Cidabenamide in Patients With Intermediate/High-risk AML

This study is a Phase II clinical trial designed to evaluate the efficacy and safety of Chidamide as maintenance therapy in high-risk acute myeloid leukemia (AML) patients following stem cell transplantation. Trial Design: The trial is a single-arm, open-label study. The experimental group plans to enroll 67 patients, while the control group (observation only) also plans to enroll approximately 67 patients, with randomization. All patients must have received induction chemotherapy prior to enrollment and may or may not have received consolidation therapy. The chemotherapy regimen was determin

Trial Details

NCT ID
NCT07304232
Phase
PHASE2
Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Chidamide
Locations (sample)
  • Shijiazhuang, Hebei, China|38.04139,114.47861
  • Harbin, Heilongjiang, China|45.75,126.65
  • Tianjin, Tianjin Municipality, China|39.14222,117.17667
  • Tianjin, Tianjin Municipality, China|39.14222,117.17667
  • Tianjin, Tianjin Municipality, China|39.14222,117.17667

Key Eligibility Criteria

  • AML patients meeting the following conditions (diagnosed per WHO 2022 AML criteria) who achieved first complete remission (CR) with intermediate-/h…
  • Patients must achieve complete remission (CR) post-transplantation.
  • Enrollment must occur between 60 and 100 days after transplantation.
  • Age 18 to 75 years.

For full eligibility, visit ClinicalTrials.gov.

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