Cyclophosphamide, Fludarabine and Antithymocyte Globulin Conditioning in Myelodysplastic Syndrome (MDS) (CyFluATG)
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|ClinicalTrials.gov Identifier: NCT01255319|
Recruitment Status : Unknown
Verified December 2010 by Cooperative Study Group A for Hematology.
Recruitment status was: Recruiting
First Posted : December 7, 2010
Last Update Posted : December 7, 2010
|Condition or disease|
- 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)
|Study Type :||Observational|
|Estimated Enrollment :||15 participants|
|Official Title:||Conditioning With Cyclophosphamide, Fludarabine and Antithymocyte Globulin for Allogeneic Hematopoietic Cell Transplantation in Lower Risk Myelodysplastic Syndrome|
|Study Start Date :||November 2010|
|Estimated Primary Completion Date :||November 2012|
|Estimated Study Completion Date :||November 2014|
- feasibility and efficacy [ Time Frame: 4years ]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 ]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.
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): NCT01255319
|Contact: Je-Hwan Lee, Doctoremail@example.com|
|Contact: Ya-Eun Jang, Nursefirstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator:||Je-Hwan Lee, Doctor||Asan Medical Center|