Flu-Bu-Mel Conditioning Regimen for Myeloid Disease

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

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

Study Overview

• Status: Completed
• Conditions: Relapse Rate After Allo-HSCT
• Intervention / Treatment: Drug: Flu-Bu-Mel

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 Type: Interventional
• Enrollment (Actual): 49
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200025
    • Blood & Marrow Transplantation Center, RuiJin Hospital
  • Shanghai, China
    • Shanghai No6 Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Flu-Bu-Mel; Fludarabine 150mg/m2 + Busulfan 3.2mg/kg 2 days + melphalan 50-70mg/m2	Drug: Flu-Bu-Mel; 5-day fludarabine + 2-day busulfan (3.2mg/kg) + 2-day melphalan (50-70mg/m2)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
disease-free survival (DFS)	From transplantation to documentation of death or relapse or progression	1 year after transplantation

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine
• Investigators: Principal Investigator: Jion HU, Head BMT program, Rui Jin Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2020
• Primary Completion (Actual): March 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: February 12, 2020
• First Submitted That Met QC Criteria: February 13, 2020
• First Posted (Actual): February 17, 2020

Study Record Updates

• Last Update Posted (Actual): October 25, 2023
• Last Update Submitted That Met QC Criteria: October 21, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence
• Other Study ID Numbers: RJH-Myeloid-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No