Evidence map›Paper›PMID 32129512›Full record

Trial reportAmerican journal of hematology2020

Fedratinib in patients with myelofibrosis previously treated with ruxolitinib: An updated analysis of the JAKARTA2 study using stringent criteria for ruxolitinib failure.

Claire N Harrison, Nicolaas Schaap, Alessandro M Vannucchi, Jean-Jacques Kiladjian, Eric Jourdan, Richard T Silver, Harry C Schouten, Francesco Passamonti, Sonja Zweegman, Moshe Talpaz and 6 more

Open access · hybridAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in American journal of hematology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 79 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
79citing papers in PubMed, 2 pooled it
12.3field-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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

79 citing papers in PubMed, 2 syntheses or guidelines pooled it, 141 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Selinexor Plus Ruxolitinib in Janus Kinase Inhibitor-Naïve Myelofibrosis: Phase III SENTRY Trial.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2026
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19 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 13 institutions in 6 countries.

Claire N HarrisonGuy's and St Thomas' Hospital, London, UK.
Nicolaas SchaapRadboud University Nijmegen Medical Centre, Nijmegen, The Netherlands.
Alessandro M VannucchiAOU Careggi, University of Florence, Florence, Italy.
Jean-Jacques KiladjianHôpital Saint-Louis, Université de Paris; Inserm, Paris, France.
Eric JourdanHématologie Clinique, Institut de Cancérologie du Gard, Nîmes, France.
Richard T SilverWeill Cornell Medical College, New York, New York, USA.
Harry C SchoutenUniversity Hospital Maastricht, Maastricht, The Netherlands.
Francesco PassamontiUniversity of Insubria, Varese, Italy.ORCID 0000-0001-8068-5289
Sonja ZweegmanAmsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.
Moshe TalpazUniversity of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, USA.
Srdan VerstovsekMD Anderson Cancer Center, Houston, Texas, USA.
Shelonitda RoseCelgene Corporation, Summit, New Jersey, USA.
Juan ShenCelgene Corporation, Summit, New Jersey, USA.
Tymara BerryCelgene Corporation, Summit, New Jersey, USA.
Carrie BrownsteinCelgene Corporation, Summit, New Jersey, USA.
Ruben A MesaUniversity of Texas Health Science Center at San Antonio, San Antonio, Texas, USA.
Bristol-Myers Squibb (Switzerland) · CHAmsterdam University Medical Centers · NLAzienda Ospedaliero-Universitaria Careggi · ITCornell University · USInserm · FRInstitut de Cancérologie de Bourgogne · FRMaastricht University Medical Centre · NLRadboud University Nijmegen · NLSt Thomas' Hospital · GBThe University of Texas Health Science Center at San Antonio · USThe University of Texas MD Anderson Cancer Center · USUniversity of Insubria · ITUniversity of Michigan · US

Funding

TISSUE CULTURE---COREP30CA054174 · NCI · UNIVERSITY OF TEXAS HLTH SCIENCE CENTER · PI Lei Zheng · 1991 to 2026
$59.1M
NCI NIH HHS P30 CA054174
6 · The paper itself

Abstract

Fedratinib is an oral, selective Janus kinase 2 (JAK2) inhibitor. The phase II JAKARTA2 study assessed fedratinib in patients with intermediate- or high-risk myelofibrosis (MF) who were resistant or intolerant to prior ruxolitinib per investigator assessment. Patients received fedratinib 400 mg/day in 28-day cycles. The JAKARTA2 outcomes were initially reported using a last-observation-carried forward (LOCF) analysis in a "Per Protocol" population. This updated analysis of JAKARTA2 employs intention-to-treat analysis principles without LOCF for all treated patients (ITT Population; N = 97), and for a patient subgroup who met more stringent definitions of prior ruxolitinib failure (Stringent Criteria Cohort; n = 79). Median duration of prior ruxolitinib exposure was 10.7 months. The primary endpoint was spleen volume response rate (SVRR; ≥35% spleen volume decrease from baseline to end of cycle 6 [EOC6]). The SVRR was 31% in the ITT Population and 30% in the Stringent Criteria Cohort. Median duration of spleen volume response was not reached. Symptom response rate (≥50% reduction from baseline to EOC6 in total symptom score [TSS] on the modified Myelofibrosis Symptom Assessment Form [MFSAF]) was 27%. Grade 3-4 anemia and thrombocytopenia rates were 38% and 22%, respectively. Patients with advanced MF substantially pretreated with ruxolitinib attained robust spleen responses and reduced symptom burden with fedratinib.

Indexed as

AdultAgedAged, 80 and overBenzenesulfonamidesFemaleHumansMaleMiddle AgedNitrilesOrgan SizePrimary MyelofibrosisPyrazolesPyrimidinesPyrrolidinesSpleenSulfonamidesBenzenesulfonamidesfedratinibNitrilesPyrazolesPyrimidinesPyrrolidinesruxolitinibSulfonamides

Identifiers

PMID32129512
PMCPMC7317815
OpenAlexW3009670005

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.