Evidence map›Paper›PMID 27247324›Full record

Trial reportHaematologica2016

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.

Haifa Kathrin Al-Ali, Martin Griesshammer, Philipp le Coutre, Cornelius F Waller, Anna Marina Liberati, Philippe Schafhausen, Renato Tavares, Pilar Giraldo, Lynda Foltz, Pia Raanani and 6 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Haematologica, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01493414 (An Open-label, Multicenter, Expanded Access Study of INC424 for Patients With Primary Myelofibrosis), which is not on this map. Cited by 83 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
83citing papers in PubMed, 1 pooled it
14.3field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01493414 phase3completednot on this map

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).

TypeinterventionalSponsorNovartis PharmaceuticalsRan2011 to 2017Enrolled2,233ConditionsMyelofibrosisArmsINC424
3 · Its place in the literature

Who cites it

83 citing papers in PubMed, 1 synthesis or guideline pooled it, 156 citations in OpenAlex.

  1. Guideline
  2. Trial
  3. Trial
  4. Randomized Trial of Ruxolitinib in Antiretroviral-Treated Adults With Human Immunodeficiency Virus.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022
    Trial
  5. Integrated Human and Murine Clinical Study Establishes Clinical Efficacy of Ruxolitinib in Chronic Myelomonocytic Leukemia.Clinical cancer research : an official journal of the American Association for Cancer Research · 2021
    Trial
  6. Trial
  7. Trial
  8. Trial
  9. Review
  10. Review
  11. Review
  12. Observational
  13. Article
  14. Article
  15. Observational
  16. Emerging Therapeutic Approaches for Anemia in Myelofibrosis.Current hematologic malignancy reports · 2025
    Review
  17. Review
  18. Article
  19. Article
  20. Article

23 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 15 institutions in 8 countries.

Haifa Kathrin Al-AliUniversity Hospital of Leipzig, Germany alah@medizin.uni-leipzig.de.
Martin GriesshammerJohannes-Wesling Academic Medical Center, University of Hannover Teaching Hospital, Minden, Germany.
Philipp le CoutreCharité - Universitätsmedizin Berlin, Germany.
Cornelius F WallerDepartment of Medicine I: Hematology and Oncology, University Hospital Freiburg, Germany.
Anna Marina LiberatiUniversity of Perugia, Azienda Ospedaliera S. Maria, Terni, Italy.
Philippe SchafhausenDepartment of Internal Medicine II, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Renato TavaresUniversidade Federal de Goiania, Goiás, Brazil.
Pilar GiraldoMiguel Servet University Hospital. IIS Aragon and Centro de Investigación Biomédica en Red de Enfermedades Raras (CIBERER), Zaragoza, Spain.
Lynda FoltzSt. Paul's Hospital, University of British Columbia, Vancouver, BC, Canada.
Pia RaananiRabin Medical Center, Petah Tikva, Israel.
Vikas GuptaPrincess Margaret Cancer Centre, Toronto, ON, Canada.
Bayane TannirNovartis Pharma AG, Basel, Switzerland.
Julian Perez RoncoNovartis Pharma AG, Basel, Switzerland.
Jagannath GhoshNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Bruno MartinoAzienda Ospedaliera Bianchi Melacrino Morelli, Reggio Calabria, Italy.
Alessandro M VannucchiUniversity of Florence, Italy.
Novartis (Switzerland) · CHAzienda ospedaliera "Bianchi-Melacrino-Morelli" · ITCentre for Biomedical Network Research on Rare Diseases · ESCharité - Universitätsmedizin Berlin · DEJohannes Wesling Klinikum Minden · DENovartis (United States) · USPrincess Margaret Cancer Centre · CARabin Medical Center · ILSt. Paul's Hospital · CAUniversidade Federal de Goiás · BRUniversität Hamburg · DEUniversity Hospital Leipzig · DEUniversity Medical Center Freiburg · DEUniversity of Florence · ITUniversity of Perugia · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

JUMP is a phase 3b expanded-access trial for patients without access to ruxolitinib outside of a clinical study; it is the largest clinical trial to date in patients with myelofibrosis who have been treated with ruxolitinib. Here, we present safety and efficacy findings from an analysis of 1144 patients with intermediate- or high-risk myelofibrosis, as well as a separate analysis of 163 patients with intermediate-1-risk myelofibrosis - a population of patients not included in the phase 3 COMFORT studies. Consistent with ruxolitinib's mechanism of action, the most common hematologic adverse events were anemia and thrombocytopenia, but these led to treatment discontinuation in only a few cases. The most common non-hematologic adverse events were primarily grade 1/2 and included diarrhea, pyrexia, fatigue, and asthenia. The rates of infections were low and primarily grade 1/2, and no new or unexpected infections were observed. The majority of patients achieved a ≥50% reduction from baseline in palpable spleen length. Improvements in symptoms were rapid, with approximately half of all patients experiencing clinically significant improvements, as assessed by various quality-of-life questionnaires. The safety and efficacy profile in intermediate-1-risk patients was consistent with that in the overall JUMP population and with that previously reported in intermediate-2- and high-risk patients. Overall, ruxolitinib provided clinically meaningful reductions in spleen length and symptoms in patients with myelofibrosis, including those with intermediate-1-risk disease, with a safety and efficacy profile consistent with that observed in the phase 3 COMFORT studies. This trial was registered as NCT01493414 at ClinicalTrials.gov.

Indexed as

AdolescentAdultAgedAged, 80 and overBiomarkersFemaleHemoglobinsHumansJanus KinasesMaleMiddle AgedNitrilesPhenotypePlatelet CountPrimary MyelofibrosisProtein Kinase InhibitorsBiomarkersHemoglobinsJanus KinasesNitrilesProtein Kinase InhibitorsPyrazolesPyrimidinesruxolitinib

Identifiers

PMID27247324
PMCPMC5060023
OpenAlexW2418937816

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.