INC424 for Patients With Primary Myelofibrosis, Post Polycythemia Myelofibrosis or Post-essential Thrombocythemia Myelofibrosis.
JUMP
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).
2 other identifiers
interventional
2,233
25 countries
273
Brief Summary
The primary objective of this study was to collect additional safety of INC424 in patients with Primary Myelofibrosis, Post Polycythemia Myelofibrosis or Post-essential Thrombocythemia Myelofibrosis, who either received prior treatment with commercially available agents or who have never received treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2011
Longer than P75 for phase_3
273 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 16, 2011
CompletedFirst Submitted
Initial submission to the registry
December 13, 2011
CompletedFirst Posted
Study publicly available on registry
December 16, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 26, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 26, 2017
CompletedResults Posted
Study results publicly available
April 26, 2019
CompletedApril 26, 2019
October 1, 2018
5.5 years
December 13, 2011
January 26, 2018
April 25, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) up to 5 Years
An adverse event (AE) is any untoward medical occurrence in a clinical trial participant regardless of causal relationship to study drug and regardless whether study drug has been administered. A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. A non-serious AE is any AE that does not meet the criteria above.
Baseline up to approximately 5 years
Secondary Outcomes (6)
Percentage of Participants With at Least 50% Reduction in Spleen Length
Baseline up to approximately 5 years
Number of Participants With Best Overall Response (BOR) up to 5 Years According to Spleen Length
Baseline up to approximately 5 years
Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to Worst Post-baseline ECOG Status up to 5 Years
Baseline up to approximately 5 years
Change in Functional Assessment of Cancer Therapy (FACT-TOI, FACT-G) and FACT-Lymphoma (FACT-Lym) Total Scores Measured at Baseline and Week 48
Baseline and Week 48
Time to First Improvement in FACT-Lym, FACIT-Fatigue Score and ECOG Performance Status
Baseline up to approximately 5 years
- +1 more secondary outcomes
Study Arms (1)
INC424
EXPERIMENTAL5 - 25 mg twice a day (BID)
Interventions
All patients enrolled into the study will receive INC424 (ruxolitinib). Starting dose is based on baseline platelet counts, with doses ranging from 5 to 20 mg twice a day. No INC424 dose will exceed 25 mg BID orally.
Eligibility Criteria
You may qualify if:
- Patients must not be eligible for another ongoing INC424 clinical trial.
- Patients must be diagnosed with PMF, PPV MF or PET-MF, according to the 2008 revised International Standard Criteria, irrespective of JAK2 mutation status..
- 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 white blood cell (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.
- 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.
- Patients must have a peripheral blood blast count of \< 10%.
- Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- 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.
You may not qualify if:
- Patients eligible for hematopoietic stem cell transplantation (suitable candidate and a suitable donor is available).
- Patients with history of malignancy in past 3 years except for treated, early-stage squamous or basal cell carcinoma in situ.
- 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).
- Patients with cardiac disease which in the Investigator's opinion may jeopardize the safety of the patient or the compliance with the protocol.
- Patients with currently uncontrolled or unstable angina, rapid or paroxysmal atrial fibrillation or recent (approximately 6 months) myocardial infarction or acute coronary syndrome.
- 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.
- Patients with known active hepatitis A, B, C or who are HIV-positive.
- 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.
- 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.
- 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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (273)
Novartis Investigative Site
Algiers, Algeria
Novartis Investigative Site
CABA, Buenos Aires, 1209, Argentina
Novartis Investigative Site
CABA, Buenos Aires, C1221ADC, Argentina
Novartis Investigative Site
Paraná, Entre Ríos Province, E3100BBJ, Argentina
Novartis Investigative Site
Buenos Aires, C1114AAN, Argentina
Novartis Investigative Site
Corrientes, W3410AVV, Argentina
Novartis Investigative Site
Córdoba, X5016KEH, Argentina
Novartis Investigative Site
Innsbruck, Tyrol, 6020, Austria
Novartis Investigative Site
Graz, A-8036, Austria
Novartis Investigative Site
Linz, 4010, Austria
Novartis Investigative Site
Linz, A-4010, Austria
Novartis Investigative Site
Salzburg, 5020, Austria
Novartis Investigative Site
Vienna, 1140, Austria
Novartis Investigative Site
Vienna, A-1090, Austria
Novartis Investigative Site
Arlon, Luxembourg, 1210, Belgium
Novartis Investigative Site
Antwerp, 2060, Belgium
Novartis Investigative Site
Bruges, 8000, Belgium
Novartis Investigative Site
Brussels, 1070, Belgium
Novartis Investigative Site
Brussels, 1090, Belgium
Novartis Investigative Site
Charleroi, 6000, Belgium
Novartis Investigative Site
Edegem, 2650, Belgium
Novartis Investigative Site
Ghent, 9000, Belgium
Novartis Investigative Site
Hasselt, 3500, Belgium
Novartis Investigative Site
Kortrijk, 8500, Belgium
Novartis Investigative Site
Leuven, 3000, Belgium
Novartis Investigative Site
Liège, 4000, Belgium
Novartis Investigative Site
Roeselare, 8800, Belgium
Novartis Investigative Site
Wilrijk, 2610, Belgium
Novartis Investigative Site
Yvoir, 5530, Belgium
Novartis Investigative Site
Goiânia, Goiás, 74605-050, Brazil
Novartis Investigative Site
Belo Horizonte, Minas Gerais, 30130-100, Brazil
Novartis Investigative Site
Curitiba, Paraná, 80060-900, Brazil
Novartis Investigative Site
Rio de Janeiro, Rio de Janeiro, 20.211-030, Brazil
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, 90035-003, Brazil
Novartis Investigative Site
Campinas, São Paulo, 13083-970, Brazil
Novartis Investigative Site
Ribeirão Preto, São Paulo, 14048-900, Brazil
Novartis Investigative Site
São Paulo, São Paulo, 01224-000, Brazil
Novartis Investigative Site
São Paulo, São Paulo, 05651-901, Brazil
Novartis Investigative Site
São Paulo, São Paulo, 08270-070, Brazil
Novartis Investigative Site
Edmonton, Alberta, T6G 1Z2, Canada
Novartis Investigative Site
Vancouver, British Columbia, V6Z1Y6, Canada
Novartis Investigative Site
Moncton, New Brunswick, E1C 6Z8, Canada
Novartis Investigative Site
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
Novartis Investigative Site
Halifax, Nova Scotia, B3H 1V7, Canada
Novartis Investigative Site
Hamilton, Ontario, L8V 5C2, Canada
Novartis Investigative Site
Ottawa, Ontario, K1H 8L6, Canada
Novartis Investigative Site
Toronto, Ontario, M5G 2M9, Canada
Novartis Investigative Site
Windsor, Ontario, N8W 2X3, Canada
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Montreal, Quebec, H2W 1S6, Canada
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Québec, Quebec, G1J 1Z4, Canada
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Saskatoon, Saskatchewan, S7N 4H4, Canada
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Bogota, Cundinamarca, 111411, Colombia
Novartis Investigative Site
Medellín, Colombia
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Brno, Czech Republic, 639 00, Czechia
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Hradec Králové, Czech Republic, 500 05, Czechia
Novartis Investigative Site
Prague, Czech Republic, 128 20, Czechia
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Olomouc, 775 20, Czechia
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Mannheim, Baden-Wurttemberg, 68305, Germany
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Aachen, 52074, Germany
Novartis Investigative Site
Aschaffenburg, 63739, Germany
Novartis Investigative Site
Bamberg, 96049, Germany
Novartis Investigative Site
Berlin, 13353, Germany
Novartis Investigative Site
Berlin, 14195, Germany
Novartis Investigative Site
Bochum, 44787, Germany
Novartis Investigative Site
Bonn, 53113, Germany
Novartis Investigative Site
Bonn, 53119, Germany
Novartis Investigative Site
Bottrop, 46236, Germany
Novartis Investigative Site
Bremen, 28177, Germany
Novartis Investigative Site
Chemnitz, 09113, Germany
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Cologne, 50671, Germany
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Cologne, 50937, Germany
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Darmstadt, 64283, Germany
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Dortmund, 44263, Germany
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Dresden, 01307, Germany
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Duisburg, 47166, Germany
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Düsseldorf, 40225, Germany
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Erlangen, 91054, Germany
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Essen, 45147, Germany
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Frankfurt, 60389, Germany
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Frankfurt, 60590, Germany
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Frankfurt (Oder), 15236, Germany
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Freiburg im Breisgau, 79106, Germany
Novartis Investigative Site
Friedrichshafen, 88045, Germany
Novartis Investigative Site
Goslar, 38642, Germany
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Göttingen, D-37075, Germany
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Greifswald, 17475, Germany
Novartis Investigative Site
Halle, 06110, Germany
Novartis Investigative Site
Hamburg, 20099, Germany
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Hamburg, 20246, Germany
Novartis Investigative Site
Hamm, 59063, Germany
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Hanover, 30625, Germany
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Hildesheim, 31135, Germany
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Ingolstadt, 85049, Germany
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Jena, 07740, Germany
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Kiel, D-24116, Germany
Novartis Investigative Site
Leer, 26789, Germany
Novartis Investigative Site
Leipzig, 04103, Germany
Novartis Investigative Site
Magdeburg, 39120, Germany
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Mainz, 55131, Germany
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Marburg, 35037, Germany
Novartis Investigative Site
Marburg, 35039, Germany
Novartis Investigative Site
Minden, 32429, Germany
Novartis Investigative Site
Moers, 47441, Germany
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München, 80331, Germany
Novartis Investigative Site
München, 81241, Germany
Novartis Investigative Site
München, 81675, Germany
Novartis Investigative Site
Nuremberg, 90403, Germany
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Oldenburg, 26133, Germany
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Rostock, 18057, Germany
Novartis Investigative Site
Stuttgart, 70376, Germany
Novartis Investigative Site
Ulm, 89081, Germany
Novartis Investigative Site
Würzburg, 97080, Germany
Novartis Investigative Site
Athens, GR, 115 27, Greece
Novartis Investigative Site
Athens, GR, GR-106 76, Greece
Novartis Investigative Site
Athens, GR 11527, Greece
Novartis Investigative Site
Pátrai, 265 00, Greece
Novartis Investigative Site
Budapest, H-1097, Hungary
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Debrecen, H-4032, Hungary
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Kaposvár, 7400, Hungary
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Szeged, H-6720, Hungary
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Szombathely, 9700, Hungary
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Cork, Cork, Ireland
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Afula, 1834111, Israel
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Haifa, 3339419, Israel
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Jerusalem, 9112001, Israel
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Petah Tikva, 49100, Israel
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Ramat Gan, 5266202, Israel
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Tel Aviv, 6423906, Israel
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Alessandria, AL, 15100, Italy
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Ancona, AN, 60126, Italy
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Avellino, AV, 83100, Italy
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Bari, BA, 70124, Italy
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Bergamo, BG, 24128, Italy
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Bologna, BO, 40138, Italy
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Brescia, BS, 25123, Italy
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Cagliari, CA, 09100, Italy
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Cagliari, CA, 09126, Italy
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Catania, CT, 95100, Italy
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Catania, CT, 95124, Italy
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Catanzaro, CZ, 88100, Italy
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Cona, FE, 44100, Italy
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San Giovanni Rotondo, FG, 71013, Italy
Novartis Investigative Site
Florence, FI, 50134, Italy
Novartis Investigative Site
Genova, GE, 16132, Italy
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Lecce, LE, 73100, Italy
Novartis Investigative Site
Monza, MB, 20900, Italy
Novartis Investigative Site
Milan, MI, 20122, Italy
Novartis Investigative Site
Milan, MI, 20133, Italy
Novartis Investigative Site
Milan, MI, 20162, Italy
Novartis Investigative Site
Modena, MO, 41100, Italy
Novartis Investigative Site
Palermo, PA, 90146, Italy
Novartis Investigative Site
Padua, PD, 35128, Italy
Novartis Investigative Site
Pescara, PE, 65124, Italy
Novartis Investigative Site
Pisa, PI, 56126, Italy
Novartis Investigative Site
Pesaro, PU, 61100, Italy
Novartis Investigative Site
Pavia, PV, 27100, Italy
Novartis Investigative Site
Rionero in Vulture, PZ, 85028, Italy
Novartis Investigative Site
Ravenna, RA, 48100, Italy
Novartis Investigative Site
Reggio Calabria, RC, 89124, Italy
Novartis Investigative Site
Reggio Emilia, RE, 42123, Italy
Novartis Investigative Site
Roma, RM, 00128, Italy
Novartis Investigative Site
Roma, RM, 00133, Italy
Novartis Investigative Site
Roma, RM, 00144, Italy
Novartis Investigative Site
Roma, RM, 00152, Italy
Novartis Investigative Site
Roma, RM, 00161, Italy
Novartis Investigative Site
Roma, RM, 00168, Italy
Novartis Investigative Site
Roma, RM, 00185, Italy
Novartis Investigative Site
Pagani, SA, 84016, Italy
Novartis Investigative Site
Siena, SI, 53100, Italy
Novartis Investigative Site
Taranto, TA, 74100, Italy
Novartis Investigative Site
Orbassano, TO, 10043, Italy
Novartis Investigative Site
Torino, TO, 10126, Italy
Novartis Investigative Site
Terni, TR, 05100, Italy
Novartis Investigative Site
Treviso, TV, 31100, Italy
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Udine, UD, 33100, Italy
Novartis Investigative Site
Varese, VA, 21100, Italy
Novartis Investigative Site
Venezia, VE, 30174, Italy
Novartis Investigative Site
Vicenza, VI, 36100, Italy
Novartis Investigative Site
Verona, VR, 37126, Italy
Novartis Investigative Site
Ronciglione, VT, 01100, Italy
Novartis Investigative Site
Napoli, 80131, Italy
Novartis Investigative Site
Napoli, 80132, Italy
Novartis Investigative Site
Napoli, 80136, Italy
Novartis Investigative Site
Novara, 28100, Italy
Novartis Investigative Site
Pavia, 27100, Italy
Novartis Investigative Site
Perugia, 06129, Italy
Novartis Investigative Site
Guadalajara, Jalisco, 44280, Mexico
Novartis Investigative Site
Mexico City, Mexico City, 06726, Mexico
Novartis Investigative Site
Monterrey, Nuevo León, 64020, Mexico
Novartis Investigative Site
Hermosillo, Sonora, 83000, Mexico
Novartis Investigative Site
Puebla City, 72000, Mexico
Novartis Investigative Site
Marrakesh, Morocco
Novartis Investigative Site
Gdansk, 80-958, Poland
Novartis Investigative Site
Katowice, 40-027, Poland
Novartis Investigative Site
Krakow, 31-503, Poland
Novartis Investigative Site
Opole, 45-372, Poland
Novartis Investigative Site
Torun, 87-100, Poland
Novartis Investigative Site
Warsaw, 02-776, Poland
Novartis Investigative Site
Coimbra, 3000-075, Portugal
Novartis Investigative Site
Faro, 8000-386, Portugal
Novartis Investigative Site
Lisbon, 1749-035, Portugal
Novartis Investigative Site
Porto, 4099-001, Portugal
Novartis Investigative Site
Vila Real, 5000 - 508, Portugal
Novartis Investigative Site
Irkutsk, 664079, Russia
Novartis Investigative Site
Moscow, 125167, Russia
Novartis Investigative Site
Nizhny Novgorod, 603126, Russia
Novartis Investigative Site
Novosibirsk, 630051, Russia
Novartis Investigative Site
Rostov-on-Don, 344022, Russia
Novartis Investigative Site
Saint Petersburg, 191024, Russia
Novartis Investigative Site
Saint Petersburg, 197341, Russia
Novartis Investigative Site
Jeddah, 21423, Saudi Arabia
Novartis Investigative Site
Riyadh, 11426, Saudi Arabia
Novartis Investigative Site
Bratislava, 85107, Slovakia
Novartis Investigative Site
Soweto, Gauteng, 2013, South Africa
Novartis Investigative Site
Cape Town, Western Province, 7801, South Africa
Novartis Investigative Site
Johannesburg, 2196, South Africa
Novartis Investigative Site
Pretoria, 0001, South Africa
Novartis Investigative Site
Pretoria, 0027, South Africa
Novartis Investigative Site
Ferrol, A Coruna, 15405, Spain
Novartis Investigative Site
Cadiz, Andalusia, 11009, Spain
Novartis Investigative Site
Granada, Andalusia, 18014, Spain
Novartis Investigative Site
Jaén, Andalusia, 23007, Spain
Novartis Investigative Site
Málaga, Andalusia, 29010, Spain
Novartis Investigative Site
Seville, Andalusia, 41009, Spain
Novartis Investigative Site
Seville, Andalusia, 41013, Spain
Novartis Investigative Site
Palma de Mallorca, Balearic Islands, 07120, Spain
Novartis Investigative Site
Sabadell, Barcelona, 08208, Spain
Novartis Investigative Site
Bilbao, Basque Country, 48013, Spain
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Donostia / San Sebastian, Basque Country, 20080, Spain
Novartis Investigative Site
Santander, Cantabria, 39008, Spain
Novartis Investigative Site
Burgos, Castille and León, 09005, Spain
Novartis Investigative Site
Salamanca, Castille and León, 37007, Spain
Novartis Investigative Site
Valladolid, Castille and León, 47012, Spain
Novartis Investigative Site
Toledo, Castille-La Mancha, 45071, Spain
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Badalona, Catalonia, 08916, Spain
Novartis Investigative Site
Barcelona, Catalonia, 08003, Spain
Novartis Investigative Site
Barcelona, Catalonia, 08035, Spain
Novartis Investigative Site
Barcelona, Catalonia, 08036, Spain
Novartis Investigative Site
Girona, Catalonia, 17007, Spain
Novartis Investigative Site
L'Hospitalet de Llobregat, Catalonia, 08907, Spain
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Tarragona, Catalonia, 43005, Spain
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Santiago de Compostela, Galicia, 15706, Spain
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Logroño, La Rioja, 26006, Spain
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Las Palmas de Gran Canaria, Las Palmas de G.C, 35010, Spain
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Alcalá de Henares, Madrid, 28805, Spain
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Majadahonda, Madrid, 28222, Spain
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Pozuelo de Alarcón, Madrid, 28223, Spain
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San Sebastián de los Reyes, Madrid, 28702, Spain
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El Palmar, Murcia, 30120, Spain
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Pamplona, Navarre, 31008, Spain
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Oviedo, Principality of Asturias, 33006, Spain
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San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320, Spain
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Alicante, Valencia, 03010, Spain
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Valencia, Valencia, 46010, Spain
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Valencia, Valencia, 46026, Spain
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Barakaldo, Vizcaya, 48903, Spain
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Barcelona, 08041, Spain
Novartis Investigative Site
Las Palmas de Gran Canaria, 35016, Spain
Novartis Investigative Site
Madrid, 28006, Spain
Novartis Investigative Site
Madrid, 28034, Spain
Novartis Investigative Site
Madrid, 28040, Spain
Novartis Investigative Site
Madrid, 28041, Spain
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Madrid, 28046, Spain
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Zaragoza, 50009, Spain
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Zaragoza, 50015, Spain
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Bangkok, 10330, Thailand
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Bangkok, 10400, Thailand
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Bangkok, 10700, Thailand
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Chiang Mai, 50200, Thailand
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Sfax, Tunisie, 3029, Tunisia
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Sousse, 4000, Tunisia
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Tunis, 1008, Tunisia
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Tunis, Tunisia
Related Publications (4)
Gupta V, Griesshammer M, Martino B, Foltz L, Tavares R, Al-Ali HK, Giraldo P, Guglielmelli P, Lomaia E, Bouard C, Paley C, Tiwari R, Zor E, Raanani P. Analysis of predictors of response to ruxolitinib in patients with myelofibrosis in the phase 3b expanded-access JUMP study. Leuk Lymphoma. 2021 Apr;62(4):918-926. doi: 10.1080/10428194.2020.1845334. Epub 2020 Nov 19.
PMID: 33210570DERIVEDAl-Ali HK, Griesshammer M, Foltz L, Palumbo GA, Martino B, Palandri F, Liberati AM, le Coutre P, Garcia-Hernandez C, Zaritskey A, Tavares R, Gupta V, Raanani P, Giraldo P, Hanel M, Damiani D, Sacha T, Bouard C, Paley C, Tiwari R, Mannelli F, Vannucchi AM. Primary analysis of JUMP, a phase 3b, expanded-access study evaluating the safety and efficacy of ruxolitinib in patients with myelofibrosis, including those with low platelet counts. Br J Haematol. 2020 Jun;189(5):888-903. doi: 10.1111/bjh.16462. Epub 2020 Feb 4.
PMID: 32017044DERIVEDTavares R, Souza CA, Paley C, Bouard C, Tiwari R, Pasquini R. A subgroup analysis of JUMP, a phase IIIb, expanded-access study evaluating the safety and efficacy of ruxolitinib in patients with myelofibrosis in a Brazilian cohort. Hematol Transfus Cell Ther. 2020 Jan-Mar;42(1):46-53. doi: 10.1016/j.htct.2019.01.009. Epub 2019 Apr 25.
PMID: 31235325DERIVEDAl-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.
PMID: 27247324DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Disclosure Office
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 13, 2011
First Posted
December 16, 2011
Study Start
August 16, 2011
Primary Completion
January 26, 2017
Study Completion
January 26, 2017
Last Updated
April 26, 2019
Results First Posted
April 26, 2019
Record last verified: 2018-10