Reduced-intensity Conditioning Allogeneic Hematopoietic Cell Transplantation Followed by Prophylactic Dose-escalating Donor Lymphocyte Infusions in Higher Risk Myelodysplastic Syndrome
16 Years
N/A
Both
Myelodysplastic Syndrome
Trial Information
Reduced-intensity Conditioning Allogeneic Hematopoietic Cell Transplantation Followed by Prophylactic Dose-escalating Donor Lymphocyte Infusions in Higher Risk Myelodysplastic Syndrome
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
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
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
Outcome Measure:
relapse incidence,duration of remission
Outcome Description:
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.
Outcome Time Frame:
4years
Safety Issue:
Yes
Principal Investigator
Je-Hwan Lee, Doctor
Investigator Role:
Principal Investigator
Investigator Affiliation:
Asan Medical Center
Authority:
Korea: Food and Drug Administration
Study ID:
Allo-039
NCT ID:
NCT01252784
Start Date:
November 2010
Completion Date:
October 2014
Related Keywords:
- Myelodysplastic Syndrome
- higher risk MDS
- Myelodysplastic Syndromes
- Preleukemia
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