JAK2 inhibitor RUXOLITINIB before allogeneic hematopoietic stem cell transplantation (HSCT) in patients with primary or secondary myelofibrosis : a prospective phase II
JAK2 inhibitor RUXOLITINIB before allogeneic hematopoietic stem cell transplantation (HSCT) in patients with primary or secondary myelofibrosis
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
78
Ruxolotinib doses calculated with platelets count and P450 cytochrome inhibitor HSCT for patients with donor
ROBIN
Paris, France
DFS
DFS is defined as the probability to be alive and in remission
Time frame: 24 months after inclusion
HSCT
* Rate of pre-graft splenectomy * Co-morbidity score defined by Sorror et al before RUXOLITINIB and after 4-month treatment just before transplantation * Post-graft haematological recovery: time to neutrophil engraftment, platelet and red blood cells transfusion independency * Acute GVHD grade II-IV incidence * Chronic GVHD incidence * Overall survival, disease-free survival, non-relapse mortality * JAK2V617E allele burden and status at registration, 3, 7, 16 months after inclusion (centralization)
Time frame: 24 months after inclusion
PATIENTS CARACTERISTICS
Patients with and without donor * Rate of patients with donor who benefit from a transplantation: * Comorbidity score at registration and after 3 months * Platelet and red blood cells transfusion independency * Performance status evolution (ECOG) * General symptoms related to myelofibrosis (questionnaire MF SAF) * Comparison of haematological response in patients with or without donor * Spleen size evolution * Comparison of quality of life in patients with and without (questionnaire EORTC) * Comparison of overall survival in patients with and without donor * Incidence of severe infections * Cytokine measure at registration, 3, and 7 months after inclusion (centralization) * MPL JAK status (at registration, centralization
Time frame: 24 months after inclusion
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