Evidence map›Paper›PMID 25151955›Full record

ReviewLeukemia2015

Clinical end points for drug treatment trials in BCR-ABL1-negative classic myeloproliferative neoplasms: consensus statements from European LeukemiaNET (ELN) and Internation Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT).

G Barosi, A Tefferi, C Besses, G Birgegard, F Cervantes, G Finazzi, H Gisslinger, M Griesshammer, C Harrison, R Hehlmann and 14 more

Registry-linked trialAbstract readReviewConsensus Statement
PubMed Full text at PMC Publisher
In one paragraph

Review in Leukemia, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06414681 (An Open Label Pilot Trial of the Combination of Tagraxofusp With Pacritinib in Patients With Intermediate-1 or Higher Myelofibrosis, Who Have Had Prior Therapy With the Approved JAK Inhibitors or in Which Therapy With the Approved JAK Inhibitors is Not Appropriate, Contraindicated or Declined), which is not on this map. Cited by 27 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

NCT06414681 early_phase1recruitingnot on this mapstarted 2025, after this paper: background citation

An Open Label Pilot Trial of the Combination of Tagraxofusp With Pacritinib in Patients With Intermediate-1 or Higher Myelofibrosis, Who Have Had Prior Therapy With the Approved JAK Inhibitors or in Which Therapy With the Approved JAK Inhibitors is Not Appropriate, Contraindicated or Declined

TypeinterventionalSponsorUniversity of Kansas Medical CenterRan2025 to 2026Enrolled20ConditionsMyelofibrosis，MFArmsTagraxofusp, Pacritinib
3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Review
  6. Review
  7. Review
  8. Article
  9. Article
  10. Review
  11. Observational
  12. Review
  13. Review
  14. Review
  15. Platelet Heterogeneity in Myeloproliferative Neoplasms.Arteriosclerosis, thrombosis, and vascular biology · 2021
    Review
  16. Review
  17. Nuclear-Cytoplasmic Transport Is a Therapeutic Target in Myelofibrosis.Clinical cancer research : an official journal of the American Association for Cancer Research · 2019
    Article
  18. Article
  19. Article
  20. Article
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

24 authors.

G BarosiCenter for the Study of Myelofibrosis, Biotechnology Research Area, IRCCS Policlinico S. Matteo Foundation, Pavia, Italy.
A TefferiDivision of Hematology, Department of Medicine, Mayo Clinic, Rochester, MN, USA.
C BessesDepartment of Haematology, Hospital del Mar-IMIM, Barcelona, Spain.
G BirgegardDepartment of Haematology, Uppsala University Hospital, Uppsala, Sweden.
F CervantesHospital Clínic, IDIBAPS, University of Barcelona, Barcelona, Spain.
G FinazziDivision of Hematology, Papa Giovanni XXIII Hospital, Bergamo, Italy.
H GisslingerDepartment of Hematology, Medical University of Vienna, Vienna, Austria.
M GriesshammerAcademic Department of Hematology and Oncology, Johannes Wesling Teaching Hospital, Minden, Germany.
C HarrisonDepartment of Haematology, Guy's and St Thomas' NHS Foundation Trust, London, UK.
R HehlmannIII Medizinische Universitätsklinik, Medizinische Fakultät Mannheim der Universität Heidelberg, Mannheim, Germany.
S Hermouet1] Inserm UMR 892, Institut de Recherche en Santé, Université de Nantes, Nantes, France [2] Chair of MPN&MPNr-EuroNet, Institut de Recherche en Santé, Université de Nantes, Nantes, France.
J-J KiladjianCentre d'Investigations Cliniques-CIC 9504, Assistance Publique -Hôpitaux de Paris, Hôpital Saint-Louis; Université Paris 7, Paris, France.
N KrögerDepartment of Stem Cell Transplantation, University Hospital Hamburg-Eppendorf, Hamburg, Germany.
R MesaDivision of Hematology and Oncology, Mayo Clinic, Scottsdale, AZ, USA.
M F Mc MullinCentre for Cancer Research and Cell Biology, Queen's University, Belfast, UK.
A PardananiDivision of Hematology, Department of Medicine, Mayo Clinic, Rochester, MN, USA.
F PassamontiDivision of Hematology, Ospedale di Circolo di Varese, Varese, Italy.
J SamuelssonDepartment of Medicine Stockholm South Hospital, Karolinska Institute, Stockholm, Sweden.
A M VannucchiDepartment of Experimental and Clinical Medicine, University of Florence, Florence, Italy.
A ReiterIII Medizinische Universitätsklinik, Medizinische Fakultät Mannheim der Universität Heidelberg, Mannheim, Germany.
R T SilverDivision of Hematology and Medical Oncology, Department of Medicine, Weill Cornell Medical College, New York, NY, USA.
S VerstovsekDepartment of Leukemia, University of Texas, M.D. Anderson Cancer Center, Houston, TX, USA.
G TognoniConsorzio Mario Negri Sud, Santa Maria Imbaro, Chieti, Italy.
T BarbuiDivision of Hematology, Papa Giovanni XXIII Hospital, Bergamo, Italy.

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

The discovery of somatic mutations, primarily JAK2V617F and CALR, in classic BCR-ABL1-negative myeloproliferative neoplasms (MPNs) has generated interest in the development of molecularly targeted therapies, whose accurate assessment requires a standardized framework. A working group, comprised of members from European LeukemiaNet (ELN) and International Working Group for MPN Research and Treatment (IWG-MRT), prepared consensus-based recommendations regarding trial design, patient selection and definition of relevant end points. Accordingly, a response able to capture the long-term effect of the drug should be selected as the end point of phase II trials aimed at developing new drugs for MPNs. A time-to-event, such as overall survival, or progression-free survival or both, as co-primary end points, should measure efficacy in phase III studies. New drugs should be tested for preventing disease progression in myelofibrosis patients with early disease in randomized studies, and a time to event, such as progression-free or event-free survival should be the primary end point. Phase III trials aimed at preventing vascular events in polycythemia vera and essential thrombocythemia should be based on a selection of the target population based on new prognostic factors, including JAK2 mutation. In conclusion, we recommended a format for clinical trials in MPNs that facilitates communication between academic investigators, regulatory agencies and drug companies.

Indexed as

Endpoint DeterminationFusion Proteins, bcr-ablHumansMyeloproliferative DisordersPrognosisBCR-ABL1 fusion protein, humanFusion Proteins, bcr-abl

Identifiers

PMID25151955
PMCPMC8764620

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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.