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OpenTrials
Completed

NCT Number: NCT04269811

Flu-Bu-Mel Conditioning Regimen for Myeloid Disease

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

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Key information

Conditions

Relapse Rate After Allo-HSCT

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Blood & Marrow Transplantation Center, RuiJin Hospital, Shanghai, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Flu-Bu-Mel

Drug

5-day fludarabine + 2-day busulfan (3.2mg/kg) + 2-day melphalan (50-70mg/m2)

Primary outcomes

  1. disease-free survival (DFS)

    Time frame: 1 year after transplantation

    From transplantation to documentation of death or relapse or progression

Secondary outcomes

  1. Overall survival (OS)

    Time frame: 1 year after transplantation

    From transplantation to documentation of death due to any causes

  2. Relapse rate

    Time frame: 1 year after transplantation

    From transplantation to documentation of relapse or progression

  3. non-relapse mortality (NRM)

    Time frame: 1 year after transplantation

    From transplantation to documentation of death not due to disease relapse or progression

  4. acute graft versus host disease (aGVHD)

    Time frame: day 180 after transplantation

    Incidence of documented grade II-IV acute GVHD

  5. chronic graft versus host disease (cGVHD)

    Time frame: 1 year after transplantation

    Incidence of documented moderate to severe chronic GVHD

  6. relapse free survival (GRFS)

    Time frame: 1 year after transplantation

    From transplantation to documentation of death, III-IV aGVHD, moderate to severe chronic GVHD and relapse

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Feb 17, 2020
Registry last updated
Oct 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.