Status:
TERMINATED
Dose-reduced Versus Standard Conditioning in MDS/sAML
Lead Sponsor:
European Society for Blood and Marrow Transplantation
Collaborating Sponsors:
Pierre Fabre Medicament
Conditions:
Myelodysplastic Syndromes
Secondary Acute Myeloid Leukemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
In this trial dose reduced conditioning is compared to standard conditioning followed by allogeneic stem cell transplantation from related or unrelated donors in patients with MDS or secondary AML. C...
Eligibility Criteria
Inclusion
- 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,
- or secondary acute myeloid leukaemia (sAML).
- 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 anti¬gen-mismatch allowed):
- No major organ dysfunction.
- Written informed consent of the patient.
Exclusion
- Blasts \> 20 % in bone marrow at time of transplantation
- No written informed consent.
- Central nervous involvement.
- Severe irreversible renal, hepatic, pulmonary or cardiac disease, such as
- Total bilirubin, SGPT or SGOT \> 2 times upper the normal level.
- Left ventricular ejection fraction \< 30 %.
- Creatinine clearance \< 30 ml/min.
- DLCO \< 35 % and/or receiving supplementary continuous oxygen.
- Positive serology for HIV.
- Pregnant or lactating women.
- Patients with a life-expectancy of less than six months because of another debilitating disease.
- Serious psychiatric or psychological disorders.
- Invasive fungal infection at time of registration.
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT01203228
Start Date
May 1 2004
End Date
February 1 2015
Last Update
April 3 2015
Active Locations (14)
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1
University Hospital
Cologne, Germany
2
University Hospital
Düsseldorf, Germany
3
Martin-Luther-Universität Halle-Wittenberg
Halle, Germany
4
University Hospital Eppendorf
Hamburg, Germany