Evidence map›Paper›PMID 35246426›Full record

ArticleBMJ open2022

Selumetinib in combination with dexamethasone for the treatment of relapsed/refractory RAS-pathway mutated paediatric and adult acute lymphoblastic leukaemia (SeluDex): study protocol for an international, parallel-group, dose-finding with expansion phase I/II trial.

Tobias Menne, Daniel Slade, Joshua Savage, Sarah Johnson, Julie Irving, Pamela Kearns, Ruth Plummer, Geoff Shenton, Gareth J Veal, Britta Vormoor and 2 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03705507 (International Phase I/II Expansion Trial of the MEK Inhibitor Selumetinib in Combination With Dexamethasone for the Treatment of Relapsed/Refractory RAS-pathway Mutated Paediatric and Adult Acute Lymphoblastic Leukaemia), which is not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
2.2field-weighted citation impact, top 13% of its field
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.

NCT03705507 phase1 / phase2terminatednot on this map

International Phase I/II Expansion Trial of the MEK Inhibitor Selumetinib in Combination With Dexamethasone for the Treatment of Relapsed/Refractory RAS-pathway Mutated Paediatric and Adult Acute Lymphoblastic Leukaemia

TypeinterventionalSponsorUniversity of BirminghamRan2018 to 2023Enrolled12ConditionsAcute Lymphoblastic Leukemia, Acute Lymphoblastic Leukemia, Adult, Acute Lymphoblastic Leukemia, Pediatric, Acute Lymphoblastic Leukemia, in RelapseArmsSelumetinib, Dexamethasone
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 13 citations in OpenAlex.

  1. Trial
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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

12 authors at 5 institutions in 2 countries.

Tobias Menne *Northern Center for Cancer Care, Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.
Daniel Slade *Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomics Cancer, University of Birmingham, Birmingham, UK.
Joshua Savage *Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomics Cancer, University of Birmingham, Birmingham, UK.ORCID 0000-0003-0599-0245
Sarah JohnsonCancer Research UK Clinical Trials Unit, Institute of Cancer and Genomics Cancer, University of Birmingham, Birmingham, UK.
Julie IrvingWolfson Childhood Cancer Research Centre, Newcastle University Centre for Cancer, Newcastle University, Newcastle upon Tyne, UK.
Pamela KearnsCancer Research UK Clinical Trials Unit, Institute of Cancer and Genomics Cancer, University of Birmingham, Birmingham, UK.
Ruth PlummerNorthern Center for Cancer Care, Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.
Geoff ShentonGreat North Children's Hospital, Royal Victoria Infirmary Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.
Gareth J VealWolfson Childhood Cancer Research Centre, Newcastle University Centre for Cancer, Newcastle University, Newcastle upon Tyne, UK.
Britta VormoorPrincess Maxima Center for Pediatric Oncology, Utrecht, The Netherlands.
Josef Vormoor *Wolfson Childhood Cancer Research Centre, Newcastle University Centre for Cancer, Newcastle University, Newcastle upon Tyne, UK.
Lucinda Billingham *Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomics Cancer, University of Birmingham, Birmingham, UK l.j.billingham@bham.ac.uk.ORCID 0000-0001-8581-4262
Cancer Research UK Clinical Trials Unit · GBNewcastle University · GBNewcastle upon Tyne Hospitals NHS Foundation Trust · GBPrincess Máxima Center · NLRoyal Victoria Infirmary · GB

Funding

Cancer Research UK 18780Cancer Research UK 23389Cancer Research UK C22436/A25354Cancer Research UK C27943/A22304Cancer Research UK C27943/A23260
6 · The paper itself

Abstract

introductionEvent-free survival rates at 15 years for paediatric patients with relapsed/refractory acute lymphoblastic leukaemia (ALL) are 30%-50%, with 5-year survival for adult patients only 20%. Many patients with newly diagnosed and relapsed ALL harbour somatic RAS-signalling activation mutations. Induction therapy for ALL involves steroids, with preclinical data suggesting the combination of dexamethasone with the MEK1/2 inhibitor, selumetinib (ARRY-142886) has a synergistic anticancer effect. METHODS AND ANALYSIS: The SeluDex trial is an international, parallel-group, dose-finding with expansion, phase I/II trial to assess the selumetinib/dexamethasone combination in adult and paediatric patients with relapsed/refractory, RAS pathway mutant ALL. The Cancer Research UK Clinical Trials Unit at University of Birmingham is the UK Coordinating Centre, with national hubs in Copenhagen, Denmark; Monza, Italy; Münster, Germany; Paris, France; and Utrecht, Netherlands. Patients with morphologically proven relapsed/refractory or progressive B-cell precursor or T-cell ALL, with demonstrated RAS pathway activating mutations are eligible. Adult patients are ETHICS AND DISSEMINATION: Medical ethical committees of all the participating countries have approved the study protocol; initial (UK) ethics approval (17/YH/0123) was granted by Yorkshire & The Humber-Leeds West Research Ethics Committee. Participants are required to provide written informed consent/assent. Results will be disseminated through national and international presentations and peer-reviewed publications. TRIAL REGISTRATION NUMBER: ISRCTN92323261.

Indexed as

BenzimidazolesPrecursor Cell Lymphoblastic Leukemia-LymphomaAdolescentAdultAntineoplastic Combined Chemotherapy ProtocolsBayes TheoremChildClinical Trials, Phase I as TopicClinical Trials, Phase II as TopicDexamethasoneHumansAZD 6244BenzimidazolesDexamethasoneadult oncologyclinical trialsleukaemiapaediatric oncology

Identifiers

PMID35246426
PMCPMC8900053
OpenAlexW4221037654

What OpenQuestion holds

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LicenceCC BY
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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.