Conditioning With Cyclophosphamide, Fludarabine and Antithymocyte Globulin for Allogeneic Hematopoietic Cell Transplantation in Lower Risk Myelodysplastic Syndrome
15 Years
N/A
Both
Myelodysplastic Syndrome
Trial Information
Conditioning With Cyclophosphamide, Fludarabine and Antithymocyte Globulin for Allogeneic Hematopoietic Cell Transplantation in Lower Risk Myelodysplastic Syndrome
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)
Inclusion Criteria:
- 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 Criteria:
- 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
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
Outcome Measure:
feasibility and efficacy
Outcome Description:
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)
Outcome Time Frame:
4years
Safety Issue:
Yes
Principal Investigator
Je-Hwan Lee, Doctor
Investigator Role:
Principal Investigator
Investigator Affiliation:
Asan Medical Center
Authority:
Korea: Food and Drug Administration
Study ID:
Allo-038
NCT ID:
NCT01255319
Start Date:
November 2010
Completion Date:
November 2014
Related Keywords:
- Myelodysplastic Syndrome
- MDS
- Myelodysplastic Syndromes
- Preleukemia
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