Evidence map›Paper›PMID 40240572›Full record

Trial reportLeukemia2025

Patient-reported outcomes in Philadelphia chromosome-positive acute lymphoblastic leukemia patients treated with ponatinib or imatinib: results from the PhALLCON trial.

Ajibade Ashaye, Ling Shi, Ibrahim Aldoss, Pau Montesinos, Pankit Vachhani, Vanderson Rocha, Cristina Papayannidis, Jessica T Leonard, Maria R Baer, Jose-Maria Ribera and 5 more

Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Leukemia, 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. Trial
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

15 authors.

Ajibade AshayeTakeda Development Center Americas, Inc., Cambridge, MA, USA. Ajibade.ashaye@takeda.com.ORCID 0000-0003-3731-0769
Ling ShiEvidera Inc., Bethesda, MD, USA.
Ibrahim AldossCity of Hope National Medical Center, Duarte, CA, USA.ORCID 0000-0001-9564-4498
Pau MontesinosHospital Universitari i Politècnic La Fe, Valencia, Spain.ORCID 0000-0002-3275-5593
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, 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.ORCID 0000-0003-1042-6024
James McCloskeyHackensack University Medical Center, Hackensack, NJ, USA.
Jianxiang WangInstitute of Hematology & Blood Diseases Hospital of CAMS & PUMC, Tianjin, China.ORCID 0000-0001-9437-9151
Sujun GaoThe First Hospital of Jilin University, Changchun, China.
Deepali RaneTakeda Development Center Americas, Inc., Cambridge, MA, USA.
Shien GuoEvidera Inc., Bethesda, MD, USA.

Funding

Takeda Pharmaceutical Company Limited | Takeda Oncology not applicable
6 · The paper itself

Abstract

In the Phase 3 PhALLCON trial (NCT03589326), ponatinib demonstrated superior efficacy and comparable safety profile versus imatinib in adults with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL). Here we report patient-reported outcomes (PRO) from PhALLCON assessed as exploratory endpoints using the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) and EQ-5D-5L. Primary PRO domains included FACT-G physical well-being, FACT-Leu subscale (FACT-LeuS), Trial Outcome Index (TOI), FACT-Leu total score, FACT-G total score, and EQ-5D visual analogue scale. Differences in least-squares mean score changes from baseline to the end of induction (EOI)/consolidation (EOC) and time to confirmed improvement/deterioration were analyzed. Overall treatment tolerability was assessed using the FACT-GP5. Analyses included 238 patients (ponatinib 159, imatinib 79) with ≥1 PRO assessment. Least-squares mean changes from baseline favored ponatinib, with significant and meaningful differences in FACT-LeuS, TOI, and FACT-Leu total score at EOI and across the primary domains except for FACT-LeuS at EOC. Median time to confirmed improvement was shorter with ponatinib versus imatinib for key measures. Ponatinib-treated patients tended to report being less bothered by treatment side effects as assessed by FACT-GP5. These findings highlight ponatinib's potentially favorable impact on health-related quality of life, supporting its use as frontline treatment for Ph+ ALL.

Indexed as

Antineoplastic AgentsImatinib MesylateImidazolesPatient Reported Outcome MeasuresPhiladelphia ChromosomePrecursor Cell Lymphoblastic Leukemia-LymphomaPyridazinesAdolescentAdultAgedFemaleFollow-Up StudiesHumansMaleMiddle AgedPrognosisAntineoplastic AgentsImatinib MesylateImidazolesponatinibPyridazines

Identifiers

PMID40240572
PMCPMC12133573

What OpenQuestion holds

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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.