Efficacy of Integrated Induction-Consolidation Chemotherapy and Transplantation for Adult Acute Myeloid Leukemia: Multicenter Study
Recruiting now · Phase 2
Conditions studied: Acute Myeloid Leukemia
In brief
This is a multicenter, single-arm, open-label clinical study designed to evaluate the efficacy and safety of an integrated "induction-consolidation-transplantation" treatment protocol in adult patients with acute myeloid leukemia (AML, excluding M3 subtype). Based on patients' economic conditions, two induction regimens are offered: the IAV regimen (idarubicin + cytarabine + venetoclax) for those with better financial resources, and the DAV regimen (daunorubicin + cytarabine + venetoclax) for those with limited resources. During the consolidation phase, patients receive either the MA regimen (liposomal mitoxantrone + intermediate-dose cytarabine) or intermediate-dose cytarabine monotherapy. Eligible patients proceed directly to allogeneic hematopoietic stem cell transplantation (allo-HSCT), with a FA-BuCy/ATG conditioning regimen and an innovative graft-versus-host disease (GVHD) prophylaxis strategy using anti-CD25 monoclonal antibody combined with delayed oral cyclosporine. The entire treatment plan is designed to be completed within four months of diagnosis. The study plans to enroll 50 newly diagnosed patients aged 14-65 years. Primary endpoints include disease-free survival (DFS), complete remission rate (CR/CRi), and the efficacy of the transplantation protocol. Secondary endpoints include relapse rate, treatment-related mortality, 2-year overall survival, and treatment safety. This study aims to explore a new strategy to improve the cure rate of AML by optimizing drug combinations and shortening the treatment duration.
Key facts
- Study ID
- NCT07108530
- Run by
- Shanxi Bethune Hospital
- People needed
- 50
- Starts
- 2025-08-06
- Expected to finish
- 2027-08-06
- Last updated by the study team
- 2025-08-07
Who can join
Age: 14 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age: 14 years - 65 years;
- Excluding AML-M3 (Acute Promyelocytic Leukemia) patients;
- Diagnosis conforming to the Chinese Diagnosis and Treatment Guidelines for Adult Acute Myeloid Leukemia (Non-APL) (2023 Edition), including low-risk, intermediate-risk, and high-risk patients;
- Bone marrow morphology indicating hypercellularity or hypocellularity;
- Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0-2.
You may not qualify if…
- Presence of intracranial hemorrhage;
- Pregnancy;
- Psychiatric illness or other conditions precluding protocol adherence;
- Severe cardiac arrhythmia, abnormal ECG (QTc >500 ms).
Where it is running
- Shanxi Bethune Hospital — Taiyuan, Shanxi, China (enrolling)
Full record on ClinicalTrials.gov
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