NCT06458257

The Efficacy of Allogeneic Hematopoietic Stem Cell Transplantation in Newly Diagnosed High-relapse-risk CEBPA Mutant Acute Myeloid Leukemia

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: —

Summary

For newly diagnosed high-relapse-risk CEBPA mutant acute myeloid leukemia patients, we aim to perform allogeneic hematopoietic stem cell transplantation after patients finished one cycle of induction and two cycles of consolidation. To access whether the therapeutic regimen is effective for high-relapse-risk CEBPA mutant acute myeloid leukemia, the disease-free-survival (DFS), overall survival (OS), non-relapse-mortality of patients is evaluated.

Detailed description

High-relapse-risk definition: Participants with non-bZIP in-frame mutations, WT1 mutated status or CD7 negative status are considered of high-relapse-risk; The positive threshold for flow cytometry MRD was 0.0001%; The MRD threshold of molecular biology is the lowest value of the detection protocol of the center.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
PROCEDURE	Allogeneic Hematopoietic Stem Cell Transplantation	Allogeneic Hematopoietic Stem Cell Transplantation
DRUG	Chemotherapy	Chemotherapy

Timeline

• Start date: 2024-10-19
• Primary completion: 2026-12-01
• Completion: 2028-12-01
• First posted: 2024-06-13
• Last updated: 2025-07-29

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study