JAK2 Inhibitors RUXOLITINIB in Patients With Myelofibrosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
Sponsor:
Information provided by (Responsible Party):
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
ClinicalTrials.gov Identifier:
NCT01795677
First received: December 21, 2012
Last updated: June 24, 2013
Last verified: February 2013

December 21, 2012
June 24, 2013
December 2012
December 2014   (final data collection date for primary outcome measure)
DFS [ Time Frame: 24 months after inclusion ] [ Designated as safety issue: Yes ]
DFS is defined as the probability to be alive and in remission
Same as current
Complete list of historical versions of study NCT01795677 on ClinicalTrials.gov Archive Site
  • HSCT [ Time Frame: 24 months after inclusion ] [ Designated as safety issue: Yes ]
    • 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 ] [ Designated as safety issue: Yes ]

    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
Same as current
Not Provided
Not Provided
 
JAK2 Inhibitors RUXOLITINIB in Patients With Myelofibrosis
JAK2 Inhibitors RUXOLITINIB in Patients With High or Intermediate Risk Primary or Secondary Myelofibrosis Eligible for Allogeneic Stem Cell Transplantation: a Prospective Multicentric Phase II Study

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

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Myelofibrosis
Drug: Ruxolotinib
Ruxolotinib doses calculated with platelets count and P450 cytochrome inhibitor HSCT for patients with donor
Other Name: Kakavi
Experimental: RUXOLOTINIB
Ruxolotinib : patient with donor HSCT 4 months later patients without donor: ruxolotinib alone
Intervention: Drug: Ruxolotinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
December 2014
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age between 18 and 69 years
  • No comorbidity contraindicating the transplantation :

    • Severe respiratory failure defined as dyspnea grade III or more
    • Severe cardiac failure defined as EF < or = 30%
    • Severe renal failure defined as creatinine clearance < 30 ml/min or dialysis
    • Dementia or non-ability to give informed consent for the protocol
    • Major alteration of performance status defined as ECOG > 2
    • Severe liver disease defined as a cirrhosis or bilirubin > 2 x ULN, or AST/ALT > 5 x ULN
  • Primary or secondary myelofibrosis diagnosed according to WHO definition (Tefferi, et al 2007)
  • Palpable splenomegaly or splenomegaly measured by any imagery (maximum size> 15 cm by ultrasound scan, Magnetic Resonance Imaging or computer tomography)
  • Disease if intermediate or high risk according to published criteria and summarized as follows:

At least one criterion among the following:

  • Haemoglobin < 100 gr/L (unrelated to medication toxicity)
  • Leucocytes < 4 G/L (unrelated to medication toxicity) or > 25 G/L
  • Poor prognosis cytogenetics : complex karyotype, abnormalities of chromosomes 5, 7 or 17 , +8, 12p-, inv(3), 11q23

Two criteria among the following criteria :

  • General symptoms (weight lost > 10% in less than 6 months, night swears, specific fever > 37.5°C)
  • Peripheral blastosis > 1% observed at least twice
  • Thrombocytopenia < 100 G/L (unrelated to treatment toxicity)

Exclusion Criteria:

  • Myelofibrosis transformed into acute leukaemia with 20% blasts of more in blood or bone marrow
  • Previous treatment with JAK2 inhibitor
  • Thrombopenia < 50 G/L
  • Comorbidities contraindicating the transplantation
  • Comorbidity score Sorror > 3
  • Pregnant or lactating women
Both
18 Years to 69 Years
No
Contact: Marie ROBIN, MD 33142499639 marie.robin@sls.aphp.fr
Contact: Valerie ROLLAND NEYRET, CRA 33 476765096 VRolland-neyret@chu-grenoble.fr
France
 
NCT01795677
JAK ALLO STUDY
Yes
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
Not Provided
Principal Investigator: MARIE ROBIN, MD FIM/GOELAMS
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP