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 ]

DFS is defined as the probability to be alive and in remission


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