Evidence map›Paper›PMID 33332189›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2021

Total Body Irradiation or Chemotherapy Conditioning in Childhood ALL: A Multinational, Randomized, Noninferiority Phase III Study.

Christina Peters, Jean-Hugues Dalle, Franco Locatelli, Ulrike Poetschger, Petr Sedlacek, Jochen Buechner, Peter J Shaw, Raquel Staciuk, Marianne Ifversen, Herbert Pichler and 25 more

3 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 183 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
183citing papers in PubMed, 5 pooled it
20.1field-weighted citation impact, top 1% 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.

NCT01949129 phase2 / phase3recruitingnot on this map

Allogeneic Stem Cell Transplantation for Children and Adolescents With Acute Lymphoblastic Leukaemia

TypeinterventionalSponsorSt. Anna KinderkrebsforschungRan2013 to 2030Enrolled1,800ConditionsAcute Lymphoblastic LeukaemiaArmsVP16, TBI, Thiotepa, Treosulfan, Fludarabine
NCT07297914 phase2 / phase3not yet recruitingnot on this mapstarted 2026, after this paper: background citation

Framework for Optimizing, Refining, and Unifying Management of HSCT in Pediatric ALL

TypeinterventionalSponsorBambino Gesù Hospital and Research InstituteRan2026 to 2032Enrolled1,000ConditionsAcute Lymphoblastic Leukemia (ALL), Stem Cell Transplant, Graft -Versus-host-diseaseArmsTotal Body Irradiation 8 Gy, Ruxolitinib, Blinatumomab, Cyclophosphamide, Total Body Irradiation 12 Gy
NCT07709195 phase2recruitingnot on this mapstarted 2024, after this paper: background citation

Chlorophyllin as an Adjunct for Reducing Oral Mucositis in Myeloablative Total Body Irradiation

TypeinterventionalSponsorTata Memorial CentreRan2024 to 2027Enrolled17ConditionsOral Mucositis, Total Body Irradiation, Hematological Malignancies, Hematopoietic Stem Cell Transplantation (HSCT)ArmsSodium Copper Chlorophyllin
3 · Its place in the literature

Who cites it

183 citing papers in PubMed, 5 syntheses or guidelines pooled it, 317 citations in OpenAlex.

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123 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

35 authors at 20 institutions in 19 countries.

Christina PetersSt. Anna Children's Hospital, Children's Cancer Research Institute, University Vienna, Vienna, Austria.
Jean-Hugues DalleHôpital Robert Debré, GH APHP-Nord Université de Paris, Paris, France.
Franco LocatelliDepartment of Pediatric Hematology and Oncology, IRCCS Ospedale Pediatrico Bambino Gesù, Sapienza University of Rome, Rome, Italy.
Ulrike PoetschgerChildren's Cancer Research Institute, Vienna, Austria.
Petr SedlacekDepartment of Pediatric Hematology and Oncology, Motol University Hospital, Prague, Czech Republic.
Jochen BuechnerDepartment of Pediatric Hematology and Oncology, Oslo University Hospital, Oslo, Norway.
Peter J ShawThe Children`s Hospital at Westmead, Sydney, Australia.
Raquel StaciukHospital de Pediatría, Buenos Aires, Argentina.
Marianne IfversenCopenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.
Herbert PichlerSt. Anna Children's Hospital, Children's Cancer Research Institute, University Vienna, Vienna, Austria.
Kim VettenrantaChildren's Hospital, University of Helsinki, Helsinki, Finland.
Peter SvecNational Institute of Children's Diseases, Bratislava, Slovakia.
Olga AleinikovaBelarusian Research Center for Pediatric Oncology, Hematology and Immunology, Borovlyani, Belarus.
Jerry SteinSchneider Children's Medical Center of Israel, Sackler Faculty of Medicine, Tel Aviv University, Petach-Tikva, Israel.
Tayfun GüngörUniversitäts-Kinderspital, Zurich, Switzerland.
Jacek ToporskiSkåne University Hospital, Lund, Sweden.
Tony H TruongAlberta Children's Hospital Calgary, Calgary, Alberta, Canada.
Cristina Diaz-de-HerediaHospital Universitari Vall d'Hebron, Barcelona, Spain.
Marc BieringsPrincess Máxima Center for Pediatric Oncology, Bilthoven, the Netherlands.
Hany AriffinUniversity of Malaya, Kuala Lumpur, Malaysia.
Mohammed EssaKing Abdullah Specialist Children's Hospital, King Abdullah International Medical Research Center, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia.
Birgit BurkhardtChildren's University Hospital Münster, Münster, Germany.
Kirk SchultzUniversity of British Columbia, Vancouver, British Columbia, Canada.
Roland MeiselDivision of Pediatric Stem Cell Therapy, Department of Pediatric Oncology, Hematology and Clinical Immunology, Medical Faculty, Heinrich-Heine-University, Duesseldorf, Germany.
Arjan LankesterWillem-Alexander Children's Hospital, Leiden, the Netherlands.
Marc AnsariGeneva University Hospital, Geneva, Switzerland.
Martin SchrappeUniversitätsklinikum Schleswig-Holstein, Kiel, Germany.
IBFM Study Group;
Arend von StackelbergCharité University Hospital Berlin, Berlin, Germany.
IntReALL Study Group
Adriana BalduzziUniversità degli Studi di Milano-Fondazione MBBM, Monza, Italy.
I-BFM SCT Study Group
Selim CorbaciogluUniversitätsklinikum Regensburg, Regensburg, Germany.
EBMT Paediatric Diseases Working Party
Peter BaderGoethe University, University Hospital Frankfurt, Department for Children and Adolescents, Division for Stem Cell Transplantation, Immunology and Intensive Care Medicine, Frankfurt am Main, Germany.
St Anna Children's Hospital · ATGoethe University Frankfurt · DEUniversity Hospital Regensburg · DEAlberta Children's Hospital · CABambino Gesù Children's Hospital · ITBelarusian Research Center For Pediatric Oncology and Hematology · BYCharité - Universitätsmedizin Berlin · DEChildren's Hospital at Westmead · AUCopenhagen University Hospital · DKHeinrich Heine University Düsseldorf · DEKing Saud bin Abdulaziz University for Health Sciences · SANational Institute of Cardiovascular Diseases · SKOslo University Hospital · NOPrincess Máxima Center · NLSkåne University Hospital · SETel Aviv University · ILUniversité Paris Cité · FRUniversity Children's Hospital Zurich · CHUniversity Hospital in Motol · CZUniversity Hospital Münster · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTotal body irradiation (TBI) before allogeneic hematopoietic stem cell transplantation (HSCT) in pediatric patients with acute lymphoblastic leukemia (ALL) is efficacious, but long-term side effects are concerning. We investigated whether preparative combination chemotherapy could replace TBI in such patients. PATIENTS AND

methodsFORUM is a randomized, controlled, open-label, international, multicenter, phase III, noninferiority study. Patients ≤ 18 years at diagnosis, 4-21 years at HSCT, in complete remission pre-HSCT, and with an HLA-compatible related or unrelated donor were randomly assigned to myeloablative conditioning with fractionated 12 Gy TBI and etoposide versus fludarabine, thiotepa, and either busulfan or treosulfan. The noninferiority margin was 8%. With 1,000 patients randomly assigned in 5 years, 2-year minimum follow-up, and one-sided alpha of 5%, 80% power was calculated. A futility stopping rule would halt random assignment if chemoconditioning was significantly inferior to TBI (EudraCT: 2012-003032-22; ClinicalTrials.gov: NCT01949129).

resultsBetween April 2013 and December 2018, 543 patients were screened, 417 were randomly assigned, 212 received TBI, and 201 received chemoconditioning. The stopping rule was applied on March 31, 2019. The median follow-up was 2.1 years. In the intention-to-treat population, 2-year overall survival (OS) was significantly higher following TBI (0.91; 95% CI, 0.86 to 0.95;

conclusionImproved OS and lower relapse risk were observed following TBI plus etoposide compared with chemoconditioning. We therefore recommend TBI plus etoposide for patients > 4 years old with high-risk ALL undergoing allogeneic HSCT.

Indexed as

AdolescentAntineoplastic Combined Chemotherapy ProtocolsBusulfanChemoradiotherapyChildChild, PreschoolEquivalence Trials as TopicEtoposideFemaleFollow-Up StudiesHumansInternational AgenciesMalePrecursor Cell Lymphoblastic Leukemia-LymphomaPrognosisSurvival RateBusulfanEtoposidefludarabineThiotepatreosulfanVidarabine

Identifiers

PMID33332189
PMCPMC8078415
OpenAlexW3112175219

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.