Condition: Allogeneic Hematopoietic Cell Transplantation (HCT) · AML (Acute Myeloid Leukemia) · Sponsor: Institute of Hematology & Blood Diseases Hospital, China
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 determined by the treating physician. Patients had received induction and/or consolidation therapy, achieved remission, and underwent stem cell transplantation. Study Objectives: The study aims to assess the impact of Chidamide maintenance therapy on recurrence-free survival (RFS), overall survival (OS), and the duration of complete remission. The study will also evaluate the tolerability and toxicity profile of this regimen, as well as the effect of maintenance therapy on the dynamics of minimal residual disease (MRD).
This description comes directly from the study's public registry record.
Jiang Erlie, doctor · +86-15122538106 · jiangerlie@ihcams.ac.cn
Liang Chen · +86-13612043271 · liangchen@ihcams.ac.cn
Always discuss trial participation with your own doctor first.
| The Second Hospital of Hebei Medical University | Shijiazhuang, Hebei, China | Not Yet Recruiting |
| The First Affiliated Hospital of Harbin Medical University | Harbin, Heilongjiang, China | Not Yet Recruiting |
| Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences | Tianjin, Tianjin Municipality, China | Recruiting |
| Tianjin Medical University General Hospital | Tianjin, Tianjin Municipality, China | Not Yet Recruiting |
| Tianjin People's Hospital | Tianjin, Tianjin Municipality, China | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT07304232