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Immediate Allogeneic Hematopoietic Stem Cell Transplantation Versus Re-treatment for Patients With High-Risk Acute Myeloid Leukemia
Sponsor: Institute of Hematology & Blood Diseases Hospital, China
Summary
This study aims to investigate whether immediate HSCT for patients with high-risk AML and intermediate-risk AML who have not achieved complete remission (CR) after their first induction therapy is non-inferior to re-treatment with chemotherapy.
Official title: Immediate Allogeneic Hematopoietic Stem Cell Transplantation Versus Re-treatment for Patients With High-Risk Acute Myeloid Leukemia: a Randomised, Open-label, Phase 2 Clinical Trial.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
358
Start Date
2025-01-01
Completion Date
2027-09-30
Last Updated
2024-12-30
Healthy Volunteers
No
Conditions
Interventions
ImmediateAllogeneic Hematopoietic Stem Cell Transplantation
patients proceeded to allogeneic HSCT as soon as possible. Patients were allowed to receive low-dose chemotherapy that is not intended for the purpose of achieving a second remission.
Retreatment
Receive a second course of anti-leukemic treatment prior to allogeneic HSCT. The anti-leukemic treatment regimen will be determined based on the genetic mutation status. Patients without targetable mutations will receive a combination of BCL-2 inhibitors and demethylating agents as salvage chemotherapy. Patients with targetable mutations will receive appropriate targeted therapy (e.g., FLT3 inhibitors, IDH inhibitors).
Locations (4)
Hebei Medical University Second Hospital
Shijiazhuang, Hebeisheng, China
Zhengzhou University First Affiliated Hospital
Zhengzhou, Henan, China
The 960th Hospital of the Joint Service Support Force of the Chinese People's Liberation Army
Jinan, Shandong, China
People's Liberation Army The General Hospital of Western Theater Command
Chengdu, Sichuan, China