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NOT YET RECRUITING
NCT06643195
NA

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

View on ClinicalTrials.gov

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

OTHER

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.

OTHER

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