Reduced-intensity Conditioning Allogeneic Hematopoietic Cell Transplantation (RICandDLI)
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Reduced-intensity Conditioning Allogeneic Hematopoietic Cell Transplantation Followed by Prophylactic Dose-escalating Donor Lymphocyte Infusions in Higher Risk Myelodysplastic Syndrome|
- relapse incidence,duration of remission [ Time Frame: 4years ] [ Designated as safety issue: Yes ]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.
- engraftment, donor chimerism, secondary graft failure,GVHD [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]•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.
Biospecimen Retention: None Retained
This clinical trial will use busulfan, fludarabine, thymoglobulin and methylprednisolone for conditioning therapy, and cyclosporine and methotrexate for prevention of GVHD. All drugs had been previously accepted for administration to human in respective indication and there is no need to further evaluate the efficacy and the safety of each drug separately. Dose-escalating DLI is also widely accepted procedure after allogeneic HCT.
|Study Start Date:||November 2010|
|Estimated Study Completion Date:||October 2014|
|Estimated Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
- 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
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01252784
|Contact: Je-Hwan Lee, Doctorfirstname.lastname@example.org|
|Contact: Ya-Eun Jang, Nurseemail@example.com|
|Korea, Republic of|
|Asan Medical Center||Recruiting|
|Seoul, Asanbyeongwon-gil, songpa-gu, Korea, Republic of, 138-736|
|Contact: Yae-Eun Jang, nurse 82-2-3010-6378 firstname.lastname@example.org|
|Principal Investigator:||Je-Hwan Lee, Doctor||Asan Medical Center|