Status:
UNKNOWN
Cyclophosphamide, Fludarabine and Antithymocyte Globulin Conditioning in Myelodysplastic Syndrome (MDS)
Lead Sponsor:
Cooperative Study Group A for Hematology
Conditions:
Myelodysplastic Syndrome
Eligibility:
All Genders
15+ years
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...
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/...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2014
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01255319
Start Date
November 1 2010
End Date
November 1 2014
Last Update
December 7 2010
Active Locations (1)
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1
Asan Medical Center
Seoul, Asanbyeongwon-gil, Songpa-gu, South Korea, 138-736