Cyclophosphamide, Fludarabine and Antithymocyte Globulin Conditioning in Myelodysplastic Syndrome (MDS)
- Conditions
- Myelodysplastic Syndrome
- Registration Number
- NCT01255319
- Lead Sponsor
- Cooperative Study Group A for Hematology
- Brief Summary
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).
- Detailed Description
Conditioning therapy
* 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.
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
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)
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 15
- Patients with lower risk MDS (bone marrow blast percentage < 5%)
- Patients with appropriate hematopoietic cell donor
- Adequate performance status (Karnofsky score of 70 or more; see Appendix II)
- Adequate hepatic and renal function (AST, ALT, and bilirubin < 3.0 x upper normal limit, and creatinine < 2.0 mg/dL).
- Adequate cardiac function (left ventricular ejection fraction of 40% or more on heart scan or echocardiogram)
- Signed and dated informed consent must be obtained from both recipient and donor.
- Presence of significant active infection
- Presence of uncontrolled bleeding
- Any coexisting major illness or organ failure
- Patients with a diagnosis of prior malignancy unless disease-free for at least 5 years following therapy with curative intent (except curatively treated nonmelanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia)
- Patients with psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible
- Nursing women, pregnant women, women of childbearing potential who do not want adequate contraception
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method feasibility and efficacy 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)
- Secondary Outcome Measures
Name Time Method progression-free survival, and overall survival 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.
Trial Locations
- Locations (1)
Asan Medical Center
🇰🇷Seoul, Asanbyeongwon-gil, songpa-gu, Korea, Republic of