Description:

ODM derived from http://clinicaltrials.gov/show/NCT00682396

Link:

http://clinicaltrials.gov/show/NCT00682396

Keywords:
Versions (2) ▾
  1. 12/9/13
  2. 4/15/14
Uploaded on:

April 15, 2014

DOI:
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License:
Creative Commons BY 4.0
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Eligibility NCT00682396 Myelodysplastic Syndrome

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
age 18 Years to 65 Years
Disease: cytologically proven
primary or therapy related myelodysplastic syndrome (MDS) either as
refractory anaemia (RA) according FAB or RA with or without dysplasia according WHO
refractory anaemia with ringsideroblasts (RARS) according FAB or RARS with or without dysplasia according WHO
refractory anaemia with excess of blasts (RAEB) according FAB or RAEB I or RAEB II according WHO
refractory anaemia with excess of blast in transformation (RAEB-T) according FAB
CMML (dysplastic type) according WHO
Secondary Acute Myeloid Leukemia
Blast count <20 percent in bone marrow with or without chemotherapy at time of transplantation
Patient eligible for standard and dose-reduced conditioning as per local guideline
Patient age 18-60 years if donor is a HLA-matched UNRELATED donor (HLA-A, HLA-B, HLA-DRB1 and HLA-DQB1) (one mismatch allowed)
Patient age 18-65 years if donor is a HLA-matched RELATED donor (HLA-A, HLA-B, HLA-DRB1 and HLA-DQB1)(one antigen-mismatch allowed)
no major organ dysfunction
written informed consent of the patient
Exclusion Criteria
Blasts >20% in bone marrow at time of transplantation
no written informed consent
Central nervous system (CNS) involvement status
Severe irreversible renal, hepatic, pulmonary or cardiac disease, such as
total bilirubin, SGPT or SGOT > 2 times upper the normal level
LVEF - Left ventricular ejection fraction
Creatinine clearance (CrCl) measurement
DLCO <35% and/or receiving supplementary continuous oxygen
Positive serology for HIV
pregnant or lactating women
patients with a life-expectancy of < 6 months because of another debilitating disease
serious psychiatric or psychological disorders
invasive fungal infection at time of registration