Evidence map›Paper›PMID 28089238›Full record

Trial reportThe Lancet. Haematology2017

Ruxolitinib for symptom control in patients with chronic lymphocytic leukaemia: a single-group, phase 2 trial.

Preetesh Jain, Michael Keating, Sarah Renner, Charles Cleeland, Huang Xuelin, Graciela Nogueras Gonzalez, David Harris, Ping Li, Zhiming Liu, Ivo Veletic and 12 more

Registry-linked trialAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Lancet. Haematology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02131584 (Administration of Jakafi), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
–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.

NCT02131584 phase2active not recruitingnot on this map

Administration of Jakafi (Ruxolitinib) for Symptom Control of Patients With Chronic Lymphocytic Leukemia (CLL): A Phase II Study

TypeinterventionalSponsorM.D. Anderson Cancer CenterRan2014 to 2026Enrolled10ConditionsChronic Lymphocytic LeukemiaArmsQuestionnaire Administration, Ruxolitinib Phosphate
3 · Its place in the literature

Who cites it

9 citing papers in PubMed.

  1. Review
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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

22 authors.

Preetesh JainDepartments of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Michael KeatingDepartments of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Sarah RennerDepartments of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Charles CleelandSymptom Research, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Huang XuelinBiostatistics, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Graciela Nogueras GonzalezBiostatistics, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
David HarrisDepartments of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Ping LiDepartments of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Zhiming LiuDepartments of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Ivo VeleticDepartments of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Uri RozovskiDepartments of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Nitin JainDepartments of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Phillip ThompsonDepartments of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Prithviraj BoseDepartments of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Courtney DiNardoDepartments of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Alessandra FerrajoliDepartments of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Susan O'BrienDepartments of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Jan BurgerDepartments of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
William WierdaDepartments of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Srdan VerstovsekDepartments of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Hagop KantarjianDepartments of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Zeev EstrovDepartments of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: zestrov@mdanderson.org.

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Fabien Delerue · 1985 to 2026
$290.8M
TOLERANCE INDUCTION BY MEGADOSE STEM CELL TRANSPLANTS IN CML--GVHD AND GVLP01CA049639 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI SHPALL, ELIZABETH J · 1990 to 2014
$41.8M
Center for Clinical and Translational Sciences (CCTS)UL1TR000371 · NCATS · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI MCPHERSON, DAVID D · 2012 to 2016
$13.4M
NCATS NIH HHS UL1 TR000371NCI NIH HHS P01 CA049639NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

backgroundDisease-related symptoms impair the quality of life of patients with chronic lymphocytic leukaemia (CLL) who do not require systemic therapy. Available therapies are not specifically aimed at symptom control. Because stimulation of the B-cell receptor activates JAK2 in CLL cells and the JAK2 inhibitor ruxolitinib improves symptoms in patients with myelofibrosis, we postulated that ruxolitinib would improve disease-related symptoms in patients with CLL. We did a phase 2 trial of ruxolitinib to test this hypothesis.

methodsSymptomatic patients with CLL who did not require systemic therapy were enrolled at MD Anderson Cancer Center (Houston, TX, USA) between Sept 15, 2014, and Sept 20, 2015. Participants were given 10 mg ruxolitinib orally twice a day. Scores on the Brief Fatigue Inventory (BFI), CLL module of the MD Anderson Symptom Inventory (MDASI) and symptom-associated interference in daily activities, were assessed before treatment and after 3 months. This trial is ongoing and is registered at ClinicalTrials.gov (NCT02131584).

findings41 patients (25 previously untreated for CLL and 16 previously treated) were enrolled. At 3 months, the mean percentage change from baseline in BFI score was 44·3% (SD 35·0, p<0·0001), in symptom interference score was 43·4% (51·5, p<0·0001), and in MDASI score was 42·1% (37·4, p<0·0001). 32 (78%) of the patients experienced 20% or greater reduction in the mean BFI, and 24 (59%) had a reduction of two units or more in worst fatigue score in past 24 hours as assessed by the BFI. The most comment grade 3-4 adverse events were neutropenia (n=2 [5%]), hypertension (n=2 [5%]), insomnia (n=1 [2%]), tinnitus and dizziness (n=1 [2%]), and thrombocytopenia (n=1 [2%]).

interpretationIn patients with CLL, ruxolitinib was associated with significant improvements in disease-related symptoms as measured by BFI, MDASI, and symptom interference scores. Further studies to test the therapeutic efficacy of ruxolitinib in CLL are warranted.

fundingIncyte, National Cancer Institute.

Indexed as

AdultAgedAntineoplastic AgentsFatigueFemaleHumansLeukemia, Lymphocytic, Chronic, B-CellMaleMiddle AgedQuality of LifeRituximabAntineoplastic AgentsRituximab

Identifiers

PMID28089238
PMCPMC5356368

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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.