JAK2 Inhibitors RUXOLITINIB in Patients With Myelofibrosis

NCT01795677 | Completed Phase 2 DMC

• 1 other identifier: JAK ALLO STUDY
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

JAK2 inhibitor RUXOLITINIB before allogeneic hematopoietic stem cell transplantation (HSCT) in patients with primary or secondary myelofibrosis : a prospective phase II

Conditions

Myelofibrosis

Keywords

JAK2 inhibitor RUXOLITINIB; Primary or secondary myelofibrosis

Outcome Measures

Primary Outcomes (1)

• DFS

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

  24 months after inclusion

Secondary Outcomes (2)

• HSCT

  24 months after inclusion

• PATIENTS CARACTERISTICS

  24 months after inclusion

Study Arms (1)

RUXOLOTINIB

EXPERIMENTAL

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

Drug: Ruxolotinib

Interventions

Ruxolotinib DRUG

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

Also known as: Kakavi

RUXOLOTINIB

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• French Innovative Leukemia Organisation: lead

Study Sites (1)

ROBIN

Paris, 75010, France

Location

Related Links

• FILO internet site

MeSH Terms

Conditions

Primary Myelofibrosis

Condition Hierarchy (Ancestors)

Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• MARIE ROBIN, MD

  FIM/GOELAMS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2012
• First Posted: February 21, 2013
• Study Start: December 1, 2012
• Primary Completion: May 1, 2018
• Study Completion: March 1, 2019
• Last Updated: July 27, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)