Flu-Bu-Mel Conditioning Regimen for Myeloid Disease

Relapse Rate After Allo-HSCT Clinical Trial

Official title:

Phase II Study ofFlu-Bu-Mel Conditioning Regimen for Patients With Myeloid Disease Undergoing Allogeneic Stem Cell Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04269811
• Other study ID #: RJH-Myeloid-2020
• Status: Completed
• Phase: Phase 2
• Start date: January 15, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: October 2023
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: June 30, 2023
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Recurrence
• Relapse Rate After Allo-HSCT

Intervention

Drug:
• Flu-Bu-Mel
5-day fludarabine + 2-day busulfan (3.2mg/kg) + 2-day melphalan (50-70mg/m2)

Locations

Country	Name	City	State
China	Blood & Marrow Transplantation Center, RuiJin Hospital	Shanghai
China	Shanghai No6 Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

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