Evidence map›Paper›PMID 41257493›Full record

ArticleFuture oncology (London, England)2025

Patient involvement in the design of ALIDHE: a study of ivosidenib + azacitidine in newly diagnosed

Samantha Nier, Jana Pelouchova, Ralph Hills, Sam Salek, Hélène Derrien, Stéphanie Chatin, Anne-Marie De La Bigne, Susana Vives, Christian Recher, Hartmut Döhner and 2 more

Abstract readClinical Trial Protocol
In one paragraph

Article in Future oncology (London, England), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

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

2 citing papers in PubMed.

  1. Review
  2. Article
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

12 authors.

Samantha NierAcute Leukemia Advocates Network, ALAN, Bern, Switzerland.ORCID 0009-0000-9885-8766
Jana PelouchovaAcute Leukemia Advocates Network, ALAN, Bern, Switzerland.ORCID 0009-0000-0144-1295
Ralph HillsAcute Leukemia Advocates Network, ALAN, Bern, Switzerland.
Sam SalekSchool of Life and Medical Sciences, University of Hertfordshire, Hatfield, UK.ORCID 0000-0002-4612-5699
Hélène DerrienServier, Suresnes, France.
Stéphanie ChatinServier, Suresnes, France.
Anne-Marie De La BigneServier, Suresnes, France.
Susana VivesHematology Department, ICO-Hospital Germans Trias I Pujol, Badalona, Spain.
Christian RecherUniversité Toulouse III Paul Sabatier, Toulouse, France.ORCID 0000-0002-3332-4525
Hartmut DöhnerDepartment of Internal Medicine III, Ulm University Hospital, Ulm, Germany.ORCID 0000-0003-2116-5536
Adriano VendittiHematology, Department of Biomedicine and Prevention, University of Rome Tor Vergata, Rome, Italy.ORCID 0000-0002-0245-0553
Paresh VyasMRC Molecular Haematology Unit, Weatherall Institute of Molecular Medicine, University of Oxford, Oxford, UK.ORCID 0000-0003-3931-0914

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsThe ALIDHE study aims to supplement previous clinical trial data by evaluating the safety and tolerability of ivosidenib + azacitidine in adult patients with newly diagnosed mutant isocitrate dehydrogenase acute myeloid leukemia (AML).

methodsNotably, this study has been designed in collaboration with patient representatives from the Acute Leukemia Advocates Network (ALAN) at all stages. Patient representatives from ALAN completed a survey and attended workshops to share feedback on the study design to reduce the burden of participation for patients. Using feedback from ALAN, the study protocol was adjusted to minimize clinical visits and optimize study duration. Quality of life and mental health were included as endpoints in ALIDHE as these outcomes have been recognized as important to capture the lived experiences of patients with AML. Efforts were made to ensure patient comprehension through accessible study documents such as a plain language video and one-page summary.

conclusionsALIDHE represents, to our knowledge, the first AML clinical trial that involves patient representatives from development of the study concept to follow-up. ALAN will continue to be involved in ALIDHE as part of the patient steering committee, to ensure that patient perspectives and needs continue to be considered throughout the study duration.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsIsocitrate DehydrogenaseLeukemia, Myeloid, AcuteMutationAdultAzacitidineGlycineHumansPyridinesQuality of LifeResearch DesignAzacitidineGlycineIDH1 protein, humanIsocitrate DehydrogenaseivosidenibPyridinesacute myeloid leukemiaazacitidineclinical trialivosidenibPatient involvementpatient representativesquality of life

Identifiers

PMID41257493
PMCPMC12688226

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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.