Evidence map›Paper›PMID 41071292›Full record

Trial reportAnnals of hematology2025

Impact of clinical response and treatment tolerability on HRQoL in newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia patients treated with ponatinib or imatinib.

Ajibade Ashaye, Ling Shi, Ibrahim Aldoss, Pau Montesinos, Pankit Vachhani, Vanderson Rocha, Cristina Papayannidis, Jessica T Leonard, Maria R Baer, Jose-Maria Ribera and 4 more

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

Trial report in Annals of hematology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03589326 (A Phase 3, Randomized, Open-label, Multicenter Study Comparing Ponatinib Versus Imatinib, Administered in Combination With Reduced-Intensity Chemotherapy, in Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

NCT03589326 phase3active not recruitingnot on this map

A Phase 3, Randomized, Open-label, Multicenter Study Comparing Ponatinib Versus Imatinib, Administered in Combination With Reduced-Intensity Chemotherapy, in Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL)

TypeinterventionalSponsorTakedaRan2018 to 2027Enrolled245ConditionsPhiladelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ALL)ArmsPonatinib, Imatinib, Vincristine, Dexamethasone, Cytarabine
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
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

14 authors.

Ajibade AshayeTakeda Development Center Americas, Inc, Cambridge, MA, USA. ajibade.ashaye@takeda.com.
Ling ShiEvidera, PPD clinical research business of Thermo Fisher Scientific, Waltham, MA, USA.
Ibrahim AldossCity of Hope National Medical Center, Duarte, CA, USA.
Pau MontesinosHospital Universitari i Politècnic La Fe, Valencia, Spain.
Pankit VachhaniUniversity of Alabama at Birmingham, Birmingham, AL, USA.
Vanderson RochaInstituto do Câncer do Estado de São Paulo, University of São Paulo, São Paulo, Brazil.
Cristina PapayannidisIRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia "L. e A. Seràgnoli," Bologna, Bologna, Italy.
Jessica T LeonardOregon Health and Science University, Portland, OR, USA.
Maria R BaerUniversity of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center, Baltimore, MD, USA.
Jose-Maria RiberaICO - Hospital Germans Trias i Pujol, Josep Carreras Leukaemia Research Institute, Badalona, Spain.
Yanyu WuTakeda Development Center Americas, Inc, Cambridge, MA, USA.
Meliessa HennessyTakeda Development Center Americas, Inc, Cambridge, MA, USA.
Alexandar VorogTakeda Development Center Americas, Inc, Cambridge, MA, USA.
Shien GuoEvidera, PPD clinical research business of Thermo Fisher Scientific, Waltham, MA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In the phase 3 PhALLCON trial (NCT03589326), ponatinib demonstrated superior efficacy, patient-reported treatment tolerability, and health-related quality of life (HRQoL) compared to imatinib in adults with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL). To explore the association between clinical response and HRQoL and substantiate the superior effect of ponatinib over imatinib on HRQoL, we analyzed the impact of clinical response and treatment tolerability on changes in HRQoL.HRQoL was assessed using the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) questionnaire and the EQ-5D-5 L. Treatment tolerability was assessed using the FACT-GP5 item "bothered by treatment side effects." Linear mixed-effects regression models were used to examine changes in HRQoL over time, with clinical response status and patient-reported overall treatment tolerability as time-varying predictors, while controlling for significant covariates.This analysis included data from 238 patients (159 ponatinib, 79 imatinib). Achieving clinical response (complete remission or incomplete remission) was associated with significantly better changes from baseline across all FACT-Leu domains and the EQ-visual analogue scale than not achieving clinical response (p < 0.05). Treatment-related side effects led to significantly and meaningfully worse changes in HRQoL than "not bothered by treatment," with higher levels of "bother" associated with greater worsening in HRQoL from baseline.Taken together with the better treatment tolerability and longer response duration of ponatinib compared to imatinib, these findings further substantiate the HRQoL benefit of ponatinib over imatinib in patients with Ph + ALL.

Indexed as

Antineoplastic AgentsImatinib MesylateImidazolesPhiladelphia ChromosomePrecursor Cell Lymphoblastic Leukemia-LymphomaPyridazinesQuality of LifeAdolescentAdultAgedFemaleHumansMaleMiddle AgedTreatment OutcomeYoung AdultAntineoplastic AgentsImatinib MesylateImidazolesponatinibPyridazinesAcute lymphoblastic leukemiaClinical responseHealth-related quality of lifeImatinibPonatinibTreatment tolerability

Identifiers

PMID41071292
PMCPMC12552232

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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.