Reduced-intensity Conditioning Allogeneic Hematopoietic Cell Transplantation (RICandDLI)
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|ClinicalTrials.gov Identifier: NCT01252784|
Recruitment Status : Unknown
Verified November 2010 by Cooperative Study Group A for Hematology.
Recruitment status was: Recruiting
First Posted : December 3, 2010
Last Update Posted : December 3, 2010
|Condition or disease|
- 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
|Study Type :||Observational|
|Estimated Enrollment :||20 participants|
|Official Title:||Reduced-intensity Conditioning Allogeneic Hematopoietic Cell Transplantation Followed by Prophylactic Dose-escalating Donor Lymphocyte Infusions in Higher Risk Myelodysplastic Syndrome|
|Study Start Date :||November 2010|
|Estimated Primary Completion Date :||October 2012|
|Estimated Study Completion Date :||October 2014|
- relapse incidence,duration of remission [ Time Frame: 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.
- engraftment, donor chimerism, secondary graft failure,GVHD [ Time Frame: 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.
Biospecimen Retention: None Retained
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|