Description:

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

Lien:
http://clinicaltrials.gov/show/NCT00682396
Mots-clés:
Versions (3)
  1. 09/12/2013 09/12/2013 - Martin Dugas
  2. 15/04/2014 15/04/2014 - Julian Varghese
  3. 20/09/2021 20/09/2021 -
Téléchargé le:

20 septembre 2021

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

Allemand Anglais
Détails

Eligibility

1 Formulaires  
  1. StudyEvent: Eligibility
    1. Eligibility
Einschlusskriterien
Alter 18 bis 65 Jahre
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
sekundäre akute myeloische Leukämie
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
Ausschlusskriterien
Blasts >20% in bone marrow at time of transplantation
no written informed consent
Zentralnervensystembeteiligung, 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
Kreatinin-Clearance
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
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