Myelodysplastic Syndrome
Conditions
Keywords
higher risk MDS
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
Interventions
None listed
Sponsors
Cooperative Study Group A for Hematology
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
South Korea
Contacts
Primary ContactJe-Hwan Lee, Doctor
Backup ContactYa-Eun Jang, Nurse
Outcome results
None listed