An interventional study of transplantation in MDS, sponsored by Groupe Francophone des Myelodysplasies. Completed at 37 sites in France. Open to participants aged 18 Years to 69 Years. Per ClinicalTrials.gov, last updated 2024-08-02.
Sponsored by Groupe Francophone des Myelodysplasies · Not applicable, Interventional, and Treatment
Comparison of survival in patients with or without a matched donor at 36 months
Patients with a matched donor (8/8 at molecular level unrelated donor or matched sibling) received an allogeneic hematopoietic stem cell transplantation.
Patients without a matched donor received the best available treatment. All patients will be followed at least 36 months or until the end of the study.
1,317 studies on the registry are indexed under Preleukemia; 57 are open to participants now.
This study's enrollment of 79 is above the median of 36 across 1,060 interventional studies indexed under Preleukemia.
Browse Preleukemia studies →Groupe Francophone des Myelodysplasies is the lead sponsor of 43 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Classical IPSS intermediate 1 or low myelodysplastic syndrome associated with at least one poor prognosis feature:
Exclusion Criteria:
Organ dysfunctions including the following
Patients with a matched donor (8/8 at molecular level unrelated donor or matched sibling)
Other: transplantation
Patients without a matched donor
allogeneic hematopoietic stem cell transplantation in patients with donor
overall survival
comparison of overall survival in patients with or without a matched donor (8/8 unrelated donor or matched sibling) at 36 months
Time frame: 36 months
quality of life
comparison of quality of life in patients with or without a matched donor, quality of life assessed by questionnaire (EORTC version 3) at inclusion, 12, 24 and 36 months
Time frame: 12, 24 and 36 months
number of patients with complete response at 36 month
comparison between patients with or without a donor for cumulative incidence of complete response at 36 month
Time frame: 36 months
number of patients with transformation in AML at 36 month
comparison between patients with or without a donor for cumulative incidence of transformation in AML at 36 month
Time frame: 36 months
proportion of patients with iron overload
proportion of patients with iron overload (Serum Ferritin (SF)\>1000 ng/mL or Red Blood Cells transfusion\>20) at time of inclusion and at 16 month after inclusion for non-transplanted patients and 12 months post-transplant for transplanted patients
Time frame: 16 months
evolution of innovative iron markers including Non-transferrin binding iron (NTBI), labile plasmatic Iron (LPI) and Hepcidine
evolution of innovative iron markers including Non-transferrin binding iron (NTBI), labile plasmatic Iron (LPI) and Hepcidine measured at time of inclusion, at 3 month and 16 month post-inclusion for all patients; In transplanted patients these markers will be measured just before conditioning regimen (J-5), Just before the transplantation (J0), at D7, 30, 100 and 12 month after transplant.
Time frame: 3 and 16 months
efficiency of chelation
the effect of chelation will be assessed at 3 month after inclusion for all patient and post transplant by measuring Serum ferritin level
Time frame: 3 and 16 months
number of patients with adverse events grade III and IV as assessed by CTCAE v4.0
comparison between patients with or without a donor for number of Grade III and IV toxicities (hematological and non-hematological) recorded according to NCI CTCAE criteria versions 4.0 during the 36 months
Time frame: 36 months
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Groupe Francophone des Myelodysplasies