Reduced-intensity Conditioning Allogeneic Hematopoietic Cell Transplantation

• Conditions: Myelodysplastic Syndrome

• Registration Number: NCT01252784
• Lead Sponsor: Cooperative Study Group A for Hematology

Brief Summary

The purpose of this study is to evaluate the feasibility and efficacy of reduced-intensity conditioning allogeneic HCT followed by prophylactic dose-escalating DLIs in patients with higher risk MDS.

Detailed Description

Conditioning therapy

* Busulfan 3.2 mg/kg/d on d-7 to -6

* Fludarabine 30 mg/m2 on d-7 to -2

* ATG 1.5-3.0 mg/kg/d on d-3 to -1

* Methylpred 2 mg/kg/d on d-4 to -1

Mobilization and harvest

* Donor

* G-CSF 10 mcg/kg/d s.c. on d-3 to 0

* Harvest of PBMCs on d 0 to +1

Infuse G-PBMCs on d 0 to d+1.

* Donor G-PBMC infusion

GVHD prophylaxis

* Cyclosporine 1.5 mg/kg i.v. q 12 hrs beginning on d-1 and changed to oral dosing (with twice the i.v. dose) when oral intake is possible. Tapered beginning between d+30 and d+60.

* Methotrexate 15 mg/m2 i.v. on d+2, and 10 mg/m2 i.v. on d+4 and d+7

Prophylactic dose-escalating DLIs

* Begin at d+120 or at least 2 wks after IST discontinuation.

* No evidence of recurrence or GVHD CD3+ cell dose increment q 4 wks 4Three dose levels

Study Timeline

• Status Verified: 2010-11
• Study Start: 2010-11
• Study First Submitted: 2010-12-01
• Study First Submitted QC: 2010-12-01
• Last Update Submitted: 2010-12-01
• Study First Posted: 2010-12-03
• Last Update Posted: 2010-12-03
• Primary Completion: 2012-10
• Study Completion: 2014-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Patients with higher risk MDS including chronic myelomonocytic leukemia

   • RAEB-1 or RAEB-2
   • IPSS Intermediate-2 or High risk category
   • Chronic myelomonocytic leukemia

2. Patients with appropriate hematopoietic cell donor

   • HLA-matched sibling
   • HLA-matched unrelated donor
   • HLA-mismatched familial donor 3.16 years old or older

Exclusion Criteria

• • Presence of significant active infection

  • Presence of uncontrolled bleeding
  • Any coexisting major illness or organ failure
  • Patients with psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
relapse incidence,duration of remission	4years	The efficacy of the treatment will be measured in terms of relapse incidence and duration of remission (the primary endpoints). The hematopoietic cell donors in the study will include HLA-matched sibling, HLA-matched unrelated donors, and HLA-mismatched familial donors.

Secondary Outcome Measures

Name	Time	Method
engraftment, donor chimerism, secondary graft failure,GVHD	4 years	•This study will evaluate engraftment, donor chimerism, secondary graft failure, acute and chronic graft-versus-host disease (GVHD), immune recovery, infections, non-relapse mortality, progression-free survival (PFS), and OS.

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Asanbyeongwon-gil, songpa-gu, Korea, Republic of