Clinical Trial: JAK2 Inhibitors RUXOLITINIB in Patients With Myelofibrosis
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: JAK2 Inhibitors RUXOLITINIB in Patients With High or Intermediate Risk Primary or Secondary Myelofibrosis Eligible for Allogeneic Stem Cell Transplantation: a Prospective
Brief Summary: JAK2 inhibitor RUXOLITINIB before allogeneic hematopoietic stem cell transplantation (HSCT) in patients with primary or secondary myelofibrosis : a prospective phase II
Detailed Summary: JAK2 inhibitor RUXOLITINIB before allogeneic hematopoietic stem cell transplantation (HSCT) in patients with primary or secondary myelofibrosis
Sponsor: French Innovative Leukemia Organisation
Current Primary Outcome: DFS [ Time Frame: 24 months after inclusion ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- HSCT [ Time Frame: 24 months after inclusion ]
- 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)
- PATIENTS CARACTERISTICS [ Time Frame: 24 months after inclusion ]
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
Original Secondary Outcome: Same as current
Information By: French Innovative Leukemia Organisation
Dates:
Date Received: December 21, 2012
Date Started: December 2012
Date Completion: March 2019
Last Updated: March 20, 2017
Last Verified: March 2017