Status:
COMPLETED
JAK2 Inhibitors RUXOLITINIB in Patients With Myelofibrosis
Lead Sponsor:
French Innovative Leukemia Organisation
Conditions:
Myelofibrosis
Eligibility:
All Genders
18-69 years
Phase:
PHASE2
Brief Summary
JAK2 inhibitor RUXOLITINIB before allogeneic hematopoietic stem cell transplantation (HSCT) in patients with primary or secondary myelofibrosis : a prospective phase II
Detailed Description
JAK2 inhibitor RUXOLITINIB before allogeneic hematopoietic stem cell transplantation (HSCT) in patients with primary or secondary myelofibrosis
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2019
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT01795677
Start Date
December 1 2012
End Date
March 1 2019
Last Update
July 27 2022
Active Locations (1)
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1
ROBIN
Paris, France, 75010