PMID- 32017044
OWN - NLM
STAT- MEDLINE
DCOM- 20210127
LR  - 20211204
IS  - 1365-2141 (Electronic)
IS  - 0007-1048 (Linking)
VI  - 189
IP  - 5
DP  - 2020 Jun
TI  - 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.
PG  - 888-903
LID - 10.1111/bjh.16462 [doi]
AB  - Ruxolitinib is a potent Janus kinase (JAK) 1/JAK2 inhibitor approved for the 
      treatment of myelofibrosis (MF). Ruxolitinib was assessed in JUMP, a large 
      (N = 2233), phase 3b, expanded-access study in MF in countries without access to 
      ruxolitinib outside a clinical trial, which included patients with low platelet 
      counts (<100 x 10(9) /l) and patients without splenomegaly - populations that 
      have not been extensively studied. The most common adverse events (AEs) were 
      anaemia and thrombocytopenia, but they rarely led to discontinuation (overall, 
      5.4%; low-platelet cohort, 12.3%). As expected, rates of worsening 
      thrombocytopenia were higher in the low-platelet cohort (all grades, 73.2% vs. 
      53.5% overall); rates of anaemia were similar (all grades, 52.9% vs. 59.5%). 
      Non-haematologic AEs, including infections, were mainly grade 1/2. Overall, 
      ruxolitinib led to meaningful reductions in spleen length and symptoms, including 
      in patients with low platelet counts, and symptom improvements in patients 
      without splenomegaly. In this trial, the largest study of ruxolitinib in patients 
      with MF to date, the safety profile was consistent with previous reports, with no 
      new safety concerns identified. This study confirms findings from the COMFORT 
      studies and supports the use of ruxolitinib in patients with platelet counts of 
      50-100 x 10(9) /l. (ClinicalTrials.gov identifier NCT01493414).
CI  - (c) 2020 British Society for Haematology and John Wiley & Sons Ltd.
FAU - Al-Ali, Haifa Kathrin
AU  - Al-Ali HK
AUID- ORCID: 0000-0001-5009-2239
AD  - Universitatsklinikum Halle, Halle (Saale), Germany.
FAU - Griesshammer, Martin
AU  - Griesshammer M
AUID- ORCID: 0000-0001-8718-7004
AD  - Johannes Wesling Medical Center Minden, University Clinic for Hematology, 
      Oncology, Hemostaseology, and Palliative Care, UKRUB, University of Bochum, 
      Minden, Germany.
FAU - Foltz, Lynda
AU  - Foltz L
AD  - St Paul's Hospital, University of British Columbia, Vancouver, BC, Canada.
FAU - Palumbo, Giuseppe A
AU  - Palumbo GA
AD  - Dipartimento di Scienze Mediche Chirurgiche e Tecnologie Avanzate "G.F. 
      Ingrassia", University of Catania, Catania, Italy.
FAU - Martino, Bruno
AU  - Martino B
AD  - Azienda Ospedaliera "Bianchi Melacrino Morelli", Reggio Calabria, Italy.
FAU - Palandri, Francesca
AU  - Palandri F
AD  - Department of Hematology/Oncology, "Seragnoli" Institute of Hematology, 
      University of Bologna School of Medicine, Bologna, Italy.
FAU - Liberati, Anna Marina
AU  - Liberati AM
AD  - University of Perugia, Azienda Ospedaliera S. Maria, Terni, Italy.
FAU - le Coutre, Philipp
AU  - le Coutre P
AD  - Charite - Universitatsmedizin Berlin, Berlin, Germany.
FAU - Garcia-Hernandez, Carmen
AU  - Garcia-Hernandez C
AD  - Hospital General de Alicante, Alicante, Spain.
FAU - Zaritskey, Andrey
AU  - Zaritskey A
AD  - Almazov National Medical Research Centre, St Petersburg, Russia.
FAU - Tavares, Renato
AU  - Tavares R
AD  - Universidade Federal de Goias, Goias, Brazil.
FAU - Gupta, Vikas
AU  - Gupta V
AD  - Princess Margaret Cancer Centre, Toronto, ON, Canada.
FAU - Raanani, Pia
AU  - Raanani P
AD  - Institute of Hematology, Davidoff Cancer Center, Rabin Medical Center, Petah 
      Tikva, and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.
FAU - Giraldo, Pilar
AU  - Giraldo P
AD  - Miguel Servet University Hospital and Centro de Investigacion Biomedica en Red de 
      Enfermedades Raras (CIBERER), Zaragoza, Spain.
FAU - Hanel, Mathias
AU  - Hanel M
AD  - Klinikum Chemnitz gGmbH, Chemnitz, Germany.
FAU - Damiani, Daniela
AU  - Damiani D
AUID- ORCID: 0000-0002-1663-4468
AD  - University of Udine, Udine, Italy.
FAU - Sacha, Tomasz
AU  - Sacha T
AUID- ORCID: 0000-0002-7207-6595
AD  - Jagiellonian University, Krakow, Poland.
FAU - Bouard, Catherine
AU  - Bouard C
AD  - Novartis Pharma S.A.S., Rueil-Malmaison, France.
FAU - Paley, Carole
AU  - Paley C
AD  - Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
FAU - Tiwari, Ranjan
AU  - Tiwari R
AD  - Novartis Healthcare Pvt Ltd, Hyderabad, India.
FAU - Mannelli, Francesco
AU  - Mannelli F
AD  - Center for Research and Innovation of Myeloproliferative Neoplasms, Azienda 
      Ospedaliero-Universitaria Careggi, University of Florence, Florence, Italy.
FAU - Vannucchi, Alessandro M
AU  - Vannucchi AM
AD  - Center for Research and Innovation of Myeloproliferative Neoplasms, Azienda 
      Ospedaliero-Universitaria Careggi, University of Florence, Florence, Italy.
LA  - eng
SI  - ClinicalTrials.gov/NCT01493414
GR  - Novartis Pharmaceuticals Corporation/International
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20200204
PL  - England
TA  - Br J Haematol
JT  - British journal of haematology
JID - 0372544
RN  - 0 (Nitriles)
RN  - 0 (Protein Kinase Inhibitors)
RN  - 0 (Pyrazoles)
RN  - 0 (Pyrimidines)
RN  - 82S8X8XX8H (ruxolitinib)
RN  - EC 2.7.10.2 (JAK1 protein, human)
RN  - EC 2.7.10.2 (JAK2 protein, human)
RN  - EC 2.7.10.2 (Janus Kinase 1)
RN  - EC 2.7.10.2 (Janus Kinase 2)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Anemia/chemically induced
MH  - Female
MH  - Humans
MH  - Janus Kinase 1/antagonists & inhibitors
MH  - Janus Kinase 2/antagonists & inhibitors
MH  - Kaplan-Meier Estimate
MH  - Leukemia, Myeloid, Acute/etiology
MH  - Male
MH  - Middle Aged
MH  - Neoplasms/etiology
MH  - Nitriles
MH  - Platelet Count
MH  - Primary Myelofibrosis/blood/complications/*drug therapy
MH  - Progression-Free Survival
MH  - Proportional Hazards Models
MH  - Protein Kinase Inhibitors/adverse effects/*therapeutic use
MH  - Pyrazoles/adverse effects/*therapeutic use
MH  - Pyrimidines
MH  - Spleen/pathology
MH  - Splenomegaly/etiology
MH  - Thrombocytopenia/chemically induced
MH  - Young Adult
OTO - NOTNLM
OT  - myelofibrosis
OT  - ruxolitinib
OT  - safety
OT  - splenomegaly
OT  - symptoms
EDAT- 2020/02/06 06:00
MHDA- 2021/01/28 06:00
CRDT- 2020/02/05 06:00
PHST- 2019/08/13 00:00 [received]
PHST- 2019/12/04 00:00 [accepted]
PHST- 2020/02/06 06:00 [pubmed]
PHST- 2021/01/28 06:00 [medline]
PHST- 2020/02/05 06:00 [entrez]
AID - 10.1111/bjh.16462 [doi]
PST - ppublish
SO  - Br J Haematol. 2020 Jun;189(5):888-903. doi: 10.1111/bjh.16462. Epub 2020 Feb 4.