Dose-reduced versus standard conditioning followed by allogeneic stem cell Transplantation in patients with MDS or sAML: A randomised phase III study
Phase 3
Withdrawn
- Conditions
- Myelodysplastic Syndrome and secondairy Acute Myeloid Leukaemia10024324
- Registration Number
- NL-OMON31335
- Lead Sponsor
- European Group for Blood and Marrow Transplantation (EBMT) tav Prof. Dr. T. de Witte
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 10
Inclusion Criteria
Cytogenetically proven MDS or sAML
Patient between 18 and 60 years of age in case of a HLA matched unrelated donor
Patient between 50 and 65 years of age in case of a HLA matched related donor
Exclusion Criteria
Blasts >20% in bone marrow at time of transplantation
Patients with a life-expectancy of less than six months because of another debilitating disease
Invasive fungal infection at time of registration
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The hypothesis is that a dose-reduced conditioning will reduce the non-relapse<br /><br>mortality from 40 % to 20 % at one year after allogeneic stem cell<br /><br>transplantation.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Comparison of haematopoietic recovery by day +30 post transplant between two<br /><br>arms.<br /><br>* Comparison of toxicity of both regimens.<br /><br>* Incidence of acute GVHD by day +100 and of chronic GVHD by day +365.<br /><br>* Overall survival and event-free survival post-transplant at two years.<br /><br>* Incidence of relapse post-transplant at two years.<br /><br>* Comparison of VOD (veno-occlusive disease0 between the two arms.<br /><br>* Comparison of infectious complications at one year and at two years after<br /><br>transplantation.<br /><br>* Comparison of quality of life between the treatment arms.</p><br>