Flu-Bu-Mel Conditioning Regimen for Myeloid Disease

Sponsor

Shanghai Jiao Tong University School of Medicine (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04269811

Collaborator

(none)

Enrollment

Locations

Arm

35.5

Anticipated Duration (Months)

24.5

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Relapse Rate After Allo-HSCT	Drug: Flu-Bu-Mel	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

49 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 15, 2020

Actual Primary Completion Date :

Jun 1, 2021

Anticipated Study Completion Date :

Dec 30, 2022

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

disease-free survival (DFS) [1 year after transplantation]
From transplantation to documentation of death or relapse or progression

Secondary Outcome Measures

Overall survival (OS) [1 year after transplantation]
From transplantation to documentation of death due to any causes
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
acute graft versus host disease (aGVHD) [day 180 after transplantation]
Incidence of documented grade II-IV acute GVHD
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Blood & Marrow Transplantation Center, RuiJin Hospital	Shanghai		China	200025
2	Shanghai No6 Hospital	Shanghai		China

Sponsors and Collaborators

Shanghai Jiao Tong University School of Medicine

Investigators

Principal Investigator: Jion HU, Head BMT program, Rui Jin Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jiong HU, Head, Blood & Marrow Transplantation Center, Shanghai Jiao Tong University School of Medicine

ClinicalTrials.gov Identifier:

NCT04269811

Other Study ID Numbers:

RJH-Myeloid-2020

First Posted:

Feb 17, 2020

Last Update Posted:

Jun 4, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Recurrence

Study Results

No Results Posted as of Jun 4, 2021