Cyclophosphamide, Fludarabine and Antithymocyte Globulin Conditioning in Myelodysplastic Syndrome (MDS) (CyFluATG)
To evaluate the feasibility and efficacy of the conditioning regimen with cyclophosphamide, fludarabine and antithymocyte globulin (CyFluATG) for allogeneic hematopoietic cell transplantation (HCT) in patients with lower risk myelodysplastic syndrome (MDS).
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Conditioning With Cyclophosphamide, Fludarabine and Antithymocyte Globulin for Allogeneic Hematopoietic Cell Transplantation in Lower Risk Myelodysplastic Syndrome|
- feasibility and efficacy [ Time Frame: 4years ] [ Designated as safety issue: Yes ]To evaluate the feasibility and efficacy of the conditioning regimen with cyclophosphamide, fludarabine and antithymocyte globulin (CyFluATG) for allogeneic hematopoietic cell transplantation (HCT) in patients with lower risk myelodysplastic syndrome (MDS). The efficacy of the treatment will be measured in terms of engraftment and non-relapse mortality (the primary endpoints)
- progression-free survival, and overall survival [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]This study will also evaluate donor chimerism, secondary graft failure, acute and chronic graft-versus-host disease (GVHD), immune recovery, infections, progression-free survival, and overall survival.
|Study Start Date:||November 2010|
|Estimated Study Completion Date:||November 2014|
|Estimated Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
- Cytoxan 50 mg/kg/d on d-3 to -2
- Fludarabine 30 mg/m2 on d-6 to -2
- Antithymocyte globulin (ATG; Thymoglobulin®) 1.5 mg/kg/d (for HLA-matched sibling donor HCT) or 3.0 mg/kg/d (for other alternative donor HCT)
- Methylpd 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
Donor G PBMC infusion
- Infuse G-PBMCs on d 0 to d+1.
- 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
Preemptive dose-escalating DLIs
- Begin at d+120 or at least 2 wks after IST discontinuation.
- Failure to achieve full donor chimerism No evidence of GVHD
- CD3+ cell dose increment q 4 wks -+ cell dose: HLA-matched donor HCT (1 x 107/kg, 5 x 107/kg, 1 x 108/kg), HLA-matched unrelated donor HCT (1 x 106/kg, 5 x 106/kg, 1 x 107/kg), HLA-matched familial donor HCT (1 x 105/kg, 5 x 105/kg, 1 x 106/kg)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01255319
|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|