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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
79
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.
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CHU d'Amiens
Amiens, France
CHU d'Angers
Angers, France
Centre hospitalier Victor Dupouy
Argenteuil, France
CHU Jean Minjoz
Besançon, France
Hôpital Avicenne
Bobigny, France
CHU de Haut Lévèque
Bordeaux, France
CHRU Côte de Nacre
Caen, France
CHU Estaing
Clermont-Ferrand, France
CHSF Gilles de Corbeil
Corbeil-Essonnes, France
Hôpital Henri Mondor
Créteil, France
...and 27 more locations
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