JAK2 Inhibitors RUXOLITINIB in Patients With Myelofibrosis | NCT01795677

Studies
JAK2 Inhibitors RUXOLITINIB in Patients With Myelofibrosis

NCT01795677

Sponsor

French Innovative Leukemia Organisation

Status

Completed

Last Update Posted

Jul 27, 2022Actual

Enrollment

78Actual

Phase

Phase 2

Conditions

Myelofibrosis

Interventions

Ruxolotinib

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2012

Primary Completion Date

May 2018Actual

Completion Date

Mar 2019Actual

First Submitted Date

Dec 21, 2012

First Submission Date that Met QC Criteria

Feb 18, 2013

First Posted Date

Feb 21, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 26, 2022

Last Update Posted Date

Jul 27, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

78Actual

Label	Type	Description	Intervention Names
RUXOLOTINIB	Experimental	Ruxolotinib : patient with donor HSCT 4 months later patients without donor: ruxolotinib alone	Drug: Ruxolotinib

Name	Type	Description	Arm Group Labels	Other Names
Ruxolotinib	Drug	Ruxolotinib doses calculated with platelets count and P450 cytochrome inhibitor HSCT for patients with donor	RUXOLOTINIB

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
DFS	DFS is defined as the probability to be alive and in remission	24 months after inclusion

Secondary Outcomes

Measure	Description	Time Frame
HSCT	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)

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

69 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D009196	Myeloproliferative Disorders
D001855	Bone Marrow Diseases
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases