MyelofibrosisPhase 2NCT01795677
JAK2 Inhibitors RUXOLITINIB in Patients With Myelofibrosis
A Phase 2 study testing Ruxolotinib in people with Myelofibrosis, run by French Innovative Leukemia Organisation at 1 site in France.
Trial summary
JAK2 inhibitor RUXOLITINIB before allogeneic hematopoietic stem cell transplantation (HSCT) in patients with primary or secondary myelofibrosis : a prospective phase II Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Myelofibrosis
- What is being tested?
- Ruxolotinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2012to Mar 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 19Show fewer
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the detailed description
JAK2 inhibitor RUXOLITINIB before allogeneic hematopoietic stem cell transplantation (HSCT) in patients with primary or secondary myelofibrosis
- Conditions
- Myelofibrosis
- Being tested
- Ruxolotinib
- Keywords
- JAK2 inhibitor RUXOLITINIB, Primary or secondary myelofibrosis
- Medical subject headings
- Primary Myelofibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RuxolotinibDrug
Also called Kakavi
Ruxolotinib doses calculated with platelets count and P450 cytochrome inhibitor HSCT for patients with donor
| Study group | Role | What they receive |
|---|---|---|
| RUXOLOTINIB | Experimental | Ruxolotinib : patient with donor HSCT 4 months later patients without donor: ruxolotinib alone Receives: Drug: Ruxolotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
DFS
DFS is defined as the probability to be alive and in remission
Measured: 24 months after inclusion
Secondary outcomes (2)
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)
Measured: 24 months after inclusion
PATIENTS CARACTERISTICS
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
Measured: 24 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2013 (estimated)
- Study startDec 2012
- Primary completionMay 2018
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyelofibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- French Innovative Leukemia Organisation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MARIE ROBIN, MD, Principal investigator, FIM/GOELAMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01795677
- Sponsor's protocol ID
- JAK ALLO STUDY
- Status last verified
- Jul 2022
- First submitted
- 21 Dec 2012
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01795677
- Acronym / sponsor ID
- JAK ALLO STUDY
- Conditions
- Myelofibrosis
- Keywords
- JAK2 inhibitor RUXOLITINIB, Primary or secondary myelofibrosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- French Innovative Leukemia OrganisationUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- May 2018 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 21 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RUXOLOTINIB | Experimental | Drug: RuxolotinibRuxolotinib : patient with donor HSCT 4 months later patients without donor: ruxolotinib alone |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Age between 18 and 69 years
- No comorbidity contraindicating the transplantation :
- 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:
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RuxolotinibAlso: KakaviRuxolotinib doses calculated with platelets count and P450 cytochrome inhibitor HSCT for patients with donor | Drug | RUXOLOTINIB |
Primary outcome
DFS
Time frame: 24 months after inclusion
DFS is defined as the probability to be alive and in remission
2 secondary outcomes
HSCT
Time frame: 24 months after inclusion
PATIENTS CARACTERISTICS
Time frame: 24 months after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
- FILO internet siteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Myelofibrosis
RecruitingPhase 3
A Phase 3 Study of Pelabresib (DAK539) and Ruxolitinib in Myelofibrosis (MF)
Primary Myelofibrosis (PMF), Post-polycythemia Vera Myelofibrosis (PPV-MF)
RecruitingPhase 3
A Study to Compare Elritercept to Placebo in Adults With Myelofibrosis and Anemia Who Are Taking Ruxolitinib
Myelofibrosis, Anemia
RecruitingObservational study
Motor Development and Early Predictors of Psychomotor Outcomes in Preterm and Term Infants Assessed by MOS-R and Caregiver Questionnaire at 18 and 36 Months
Neurodevelopmental Disorders, Motor Skills Disorders
Active, not recruitingPhase 3
Study of Selinexor in Combination With Ruxolitinib in Myelofibrosis
Myelofibrosis
RecruitingPhase 2
Study of Momelotinib in Combination With Luspatercept in Participants With Transfusion Dependent Myelofibrosis
Primary Myelofibrosis, Myelofibrosis; Primary Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MARIE ROBIN, MD principal investigator
FIM/GOELAMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ruxolotinib in people with Myelofibrosis, run by French Innovative Leukemia Organisation at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DFS (time frame: 24 months after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2022.