Flu-Bu-Mel Conditioning Regimen for Myeloid Disease

Phase 2

Completed

• Conditions: Relapse Rate After Allo-HSCT
• Interventions: Drug: Flu-Bu-Mel

• Registration Number: NCT04269811
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

Brief Summary

For patients with acute myeloid leukemia (AML) or myelodyspasia syndrome undergoing allo-HSCT, the conditioning regimen will be 5-day Fludarabine, 2-day Busulifan and 2-day melphalan

Detailed Description

For patients with acute myeloid leukemia (AML) or myelodyspasia syndrome undergoing allo-HSCT, the conditioning regimen will be Fludarabine (30mg/m2, d-7 to d-3) + Busulifan 3.2mg/kg (d-7 to d-6) + melphalan 70mg/m2 (d-4 and d-3). The GVHD prophylaxis will be PT-CY (Cyclophosphamide 50mg/kg d+3 and d+4) + low-dose ATG (2.5mg/kg) on d+15.

Study Timeline

• Study Start: 2020-01-15
• Study First Submitted: 2020-02-12
• Study First Submitted QC: 2020-02-13
• Study First Posted: 2020-02-17
• Primary Completion: 2023-03-30
• Study Completion: 2023-06-30
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-21
• Last Update Posted: 2023-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

• acute myeloid leukemia (CR1 or CR2) or myelodysplasia syndrome
• patients with HLA matched sibling, unrelated or Haplo-identical donor

Exclusion Criteria

• patients with active infection
• patients with abnormal liver function damage: ALT/AST above 2X normal range
• patients with abnormal renal function damage Scr>160µmol/L;
• patients with insufficient pulmonary function (FEV1，FVC，DLCO<50%）and heart failure or with EF <50%)
• patients with mental instability or unwilling to give inform consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Flu-Bu-Mel	Flu-Bu-Mel	Fludarabine 150mg/m2 + Busulfan 3.2mg/kg 2 days + melphalan 50-70mg/m2

Primary Outcome Measures

Name	Time	Method
disease-free survival (DFS)	1 year after transplantation	From transplantation to documentation of death or relapse or progression

Secondary Outcome Measures

Name	Time	Method
Relapse rate	1 year after transplantation	From transplantation to documentation of relapse or progression
non-relapse mortality (NRM)	1 year after transplantation	From transplantation to documentation of death not due to disease relapse or progression
chronic graft versus host disease (cGVHD)	1 year after transplantation	Incidence of documented moderate to severe chronic GVHD
relapse free survival (GRFS)	1 year after transplantation	From transplantation to documentation of death, III-IV aGVHD, moderate to severe chronic GVHD and relapse
Overall survival (OS)	1 year after transplantation	From transplantation to documentation of death due to any causes
acute graft versus host disease (aGVHD)	day 180 after transplantation	Incidence of documented grade II-IV acute GVHD

Trial Locations

Locations (2)

Blood & Marrow Transplantation Center, RuiJin Hospital; 🇨🇳 Shanghai, China

Shanghai No6 Hospital; 🇨🇳 Shanghai, China