Trial | NCT01795677  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    78
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 Started
Dec 31
2012
Primary Completion
May 31
2018
Study Completion
Mar 31
2019
Last Update
Jul 27
2022

Drug Ruxolotinib

Ruxolotinib doses calculated with platelets count and P450 cytochrome inhibitor HSCT for patients with donor

  • Other names: Kakavi

RUXOLOTINIB Experimental

Ruxolotinib : patient with donor HSCT 4 months later patients without donor: ruxolotinib alone

Criteria 

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
No Results Posted