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Trial record 1 of 1 for:    INC424 for Patients with Myelofibrosis (JUMP)
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INC424 for Patients With Primary Myelofibrosis, Post Polycythemia Myelofibrosis or Post-essential Thrombocythemia Myelofibrosis. (JUMP)

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ClinicalTrials.gov Identifier: NCT01493414
Recruitment Status : Completed
First Posted : December 16, 2011
Last Update Posted : December 21, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

December 13, 2011
December 16, 2011
December 21, 2017
August 16, 2011
January 26, 2016   (Final data collection date for primary outcome measure)
Number of participants with treatment related adverse events up to 5 years [ Time Frame: Baseline up to approximately 5 years. ]
The occurrence of adverse events may be volunteered by the patient or obtained by non-directive questioning at each visit during the study or through physical examination, laboratory test, or other assessments.
Not Provided
Complete list of historical versions of study NCT01493414 on ClinicalTrials.gov Archive Site
  • Best overall response up to 5 years. [ Time Frame: Baseline up to approximately 5 years. ]
    Overall response is analyzed using the spleen response, as assessed by the investigator and also by deriving the response using IWG MRT criteria. Spleen response is also analyzed by proportion of patients achieving at least 50% reduction in spleen length at any time during the study.
  • Change in ECOG Performance Status up to 5 years. [ Time Frame: Baseline up to approximately 5 years. ]
    ECOG performance score will be summarized from baseline versus worst-post baseline scores.
  • Functional Assessment of Cancer Therapy (FACT-TOI, FACT-G) and FACT-Lymphoma (FACT-Lym) total scores up to Week 48. [ Time Frame: Baseline to Week 48. ]
    The FACT-Lym questionnaire consists of a total of 42 questions divided between five subscales (i.e., physical well-being, social/family well-being, emotional well-being, functional well-being and lymphoma subscale) which in turn contribute to three total sum scores, namely FACT-Lym Trial Outcome Index (TOI), FACT-General (FACT-G) total score and FACT- Lym total score.
  • Medical resource utilization up to 5 years. [ Time Frame: Baseline up to approximately 5 years. ]
    Percentage of patients requiring medical ressources (blood tranfusions, hospitalization, emergency room visits, general practitioners or specialists consultations, urgent care or splenic irradiation) by quarter and up to 5 years.
Not Provided
Not Provided
Not Provided
 
INC424 for Patients With Primary Myelofibrosis, Post Polycythemia Myelofibrosis or Post-essential Thrombocythemia Myelofibrosis.
An Open-label, Multicenter, Expanded Access Study of INC424 for Patients With Primary Myelofibrosis (PMF) or Post Polycythemia Myelofibrosis (PPV MF) or Post-essential Thrombocythemia Myelofibrosis (PET-MF).
The primary objective of this study is collect additional safety of INC424 in patients with Primary Myelofibrosis, Post Polycythemia Myelofibrosis or Post-essential Thrombocythemia Myelofibrosis, who have either received prior treatment with commercially available agents or who have never received treatment.
Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Myelofibrosis
Drug: INC424
All patients enrolled into the study will receive INC424 (ruxolitinib). Starting dose is based on baseline platelet counts, with doses ranging from 5 to 25 mg twice a day. No INC424 dose will exceed 25 mg BID orally.
Other Name: Ruxolitinib
Experimental: INC424
5 - 25 mg twice a day, per os
Intervention: Drug: INC424
Al-Ali HK, Griesshammer M, le Coutre P, Waller CF, Liberati AM, Schafhausen P, Tavares R, Giraldo P, Foltz L, Raanani P, Gupta V, Tannir B, Ronco JP, Ghosh J, Martino B, Vannucchi AM. Safety and efficacy of ruxolitinib in an open-label, multicenter, single-arm phase 3b expanded-access study in patients with myelofibrosis: a snapshot of 1144 patients in the JUMP trial. Haematologica. 2016 Sep;101(9):1065-73. doi: 10.3324/haematol.2016.143677. Epub 2016 May 31.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2232
Not Provided
January 26, 2016
January 26, 2016   (Final data collection date for primary outcome measure)

Main Inclusion Criteria:

  1. Patients must not be eligible for another ongoing INC424 clinical trial.
  2. Patients must be diagnosed with PMF, PPV MF or PET-MF, according to the 2008 revised International Standard Criteria, irrespective of JAK2 mutation status..
  3. Patients with PMF requiring therapy must be classified as high risk (3 prognostic factors) OR intermediate risk level 2 (2 prognostic factors, no more), OR intermediate risk level 1 (1 prognostic factor, no more) with an enlarged spleen (assessment to occur at the Screening Visit).

    The prognostic factors, defined by the International Working Group are:

    • Age > 65 years;
    • Presence of constitutional symptoms (weight loss, fever, night sweats);
    • Marked anemia (Hgb < 10g/dL)*;
    • Leukocytosis (history of WBC > 25 x109/L);
    • Circulating blasts > 1%. * A hemoglobin value < 10 g/dL must be demonstrated during the Screening Visit for patients who are not transfusion dependent. Patients receiving regular transfusions of packed red blood cells will be considered to have hemoglobin < 10 g/dL for the purpose of evaluation of risk factors.
  4. Patients with Intermediate-1 disease and splenomegaly must have a palpable spleen measuring 5 cm or greater from the costal margin to the point of greatest splenic protrusion.
  5. Patients must have a peripheral blood blast count of < 10%.
  6. Patients with an ECOG performance status of 0, 1, or 2.
  7. Fedratinib pretreated patients with documented complete physical examination including full neurologic examination and cardiology assessment, thiamine level testing, and MRI of the brain if indicated based on signs or symptoms. Patients pretreated with fedratinib should have completed or be receiving thiamine supplementation according to the investigator's instructions.

Main Exclusion Criteria:

  1. Patients eligible for hematopoietic stem cell transplantation (suitable candidate and a suitable donor is available).
  2. Patients with history of malignancy in past 3 years except for treated, early-stage squamous or basal cell carcinoma in situ.
  3. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral INC424 (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection).
  4. Patients with cardiac disease which in the Investigator's opinion may jeopardize the safety of the patient or the compliance with the protocol.
  5. Patients with currently uncontrolled or unstable angina, rapid or paroxysmal atrial fibrillation or recent (approximately 6 months) myocardial infarction or acute coronary syndrome.
  6. Patients with clinically significant bacterial, fungal, parasitic or viral infection which require therapy. Patients with acute bacterial infections requiring antibiotic use should delay screening/enrollment until the course of antibiotic therapy has been completed.
  7. Patients with known active hepatitis A, B, C or who are HIV-positive.
  8. Patients with inadequate bone marrow reserve at the Baseline visit as demonstrated by:

    • Absolute neutrophil count (ANC) ≤ 1000/µL.
    • Platelet count < 50,000/µL without the assistance of growth factors, thrombopoietic factors or platelet transfusions.
  9. Patients with any history of platelet counts < 50,000/µL or ANC < 500/µL except during treatment for a myeloproliferative disorder or treatment with cytotoxic therapy for any other reason.
  10. In the case of ruxolitinib pretreated patients, ruxolitinib primary resistant patients defined as:

    • No spleen reduction within the first 12 weeks after front line therapy with ruxolitinib.

    AND

    • No reduction in symptoms within the first 12 weeks after first-line treatment with ruxolitinib.

  11. In the case of ruxolitinib pretreated patients, patients discontinuing ruxolitinib due to a Grade 4 AE related or suspected to be related to ruxolitinib.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Algeria,   Argentina,   Austria,   Belgium,   Brazil,   Canada,   Colombia,   Czechia,   Germany,   Greece,   Hungary,   Ireland,   Israel,   Italy,   Mexico,   Morocco,   Poland,   Portugal,   Russian Federation,   Saudi Arabia,   Slovakia,   South Africa,   Spain,   Thailand,   Tunisia
Czech Republic,   Egypt,   Kuwait,   Netherlands,   United Arab Emirates,   United Kingdom,   Venezuela
 
NCT01493414
CINC424A2401
2010-024473-39 ( EudraCT Number )
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Undecided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP