Evidence map›Paper›PMID 25652604›Full record

Trial reportJournal of hematology & oncology2015

Non-myeloablative allogeneic hematopoietic cell transplantation following fludarabine plus 2 Gy TBI or ATG plus 8 Gy TLI: a phase II randomized study from the Belgian Hematological Society.

Frédéric Baron, Pierre Zachée, Johan Maertens, Tessa Kerre, Aurélie Ory, Laurence Seidel, Carlos Graux, Philippe Lewalle, Michel Van Gelder, Koen Theunissen and 4 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of hematology & oncology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00603954 (Allogeneic Hematopoietic Cell Transplantation With HLA-matched Donors), which is not on this map. Cited by 28 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 1 pooled it
4.8field-weighted citation impact, top 5% 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.

NCT00603954 phase2completednot on this map

Allogeneic Hematopoietic Cell Transplantation With HLA-matched Donors : a Phase II Randomized Study Comparing 2 Nonmyeloablative Conditionings

TypeinterventionalSponsorUniversity of LiegeRan2008 to 2016Enrolled107ConditionsHematological MalignanciesArmsConditioning regimen: TBI + Fludarabine, Conditioning regimen:TLI (8 Gy) + ATG
3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 1 synthesis or guideline pooled it, 43 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Conditioning Regimen Options.Advances in experimental medicine and biology · 2025
    Review
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  14. Clinical trials of CAR-T cells in China.Journal of hematology & oncology · 2017
    Article
  15. Validation of the Hematopoietic Cell Transplantation-Specific Comorbidity Index in Nonmyeloablative Allogeneic Stem Cell Transplantation.Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2017
    Article
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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

14 authors at 10 institutions in 2 countries.

Frédéric BaronDepartment of Hematology, University of Liège, and CHU of Liège, Sart-Tilman, 4000, Liège, Belgium. f.baron@ulg.ac.be.
Pierre ZachéeZNA Stuivenberg, Antwerpen, Belgium. Pierre.Zachee@zna.be.
Johan MaertensAZ Gasthuisberg Leuven, Leuven, Belgium. johan.maertens@uzleuven.be.
Tessa KerreGhent University Hospital, Ghent, Belgium. Tessa.Kerre@UGent.be.
Aurélie OryDepartment of Hematology, University of Liège, and CHU of Liège, Sart-Tilman, 4000, Liège, Belgium. aurelie.ory@chu.ulg.ac.be.
Laurence SeidelDepartment of Statistics, University of Liège, and CHU of Liège, Liège, Belgium. laurence.seidel@chu.ulg.ac.be.
Carlos GrauxMont-Godine University Hospital (UCL), Yvoir, Belgium. carlos.graux@uclouvain.be.
Philippe LewalleJules Bordet Institute (ULB), Bruxelles, Belgium. philippe.lewalle@bordet.be.
Michel Van GelderMaastricht University Medical Center, Maastricht, The Netherlands. m.van.gelder@mumc.nl.
Koen TheunissenJessa Ziekenhuis, Hasselt, Belgium. Koen.Theunissen@virgajesse.be.
Evelyne WillemsDepartment of Hematology, University of Liège, and CHU of Liège, Sart-Tilman, 4000, Liège, Belgium. e.willems@chu.ulg.ac.be.
Marie-Paule EmondsHLA Red Cross Flanders, Mechelen, Belgium. Marie-Paule.Emonds@rodekruis.be.
Ann De BeckerUniversitair Ziekenhuis Brussel (UZ Brussels), Brussels, Belgium. Ann.DeBecker@uzbrussel.be.
Yves BeguinDepartment of Hematology, University of Liège, and CHU of Liège, Sart-Tilman, 4000, Liège, Belgium. yves.beguin@chu.ulg.ac.be.
University of Liège · BECHU Dinant Godinne UCL Namur · BEGhent University Hospital · BEInstitut Jules Bordet · BEJessa Hospital · BEMaastricht University · NLRode Kruis-Vlaanderen · BEUniversitair Ziekenhuis Brussel · BEUniversitair Ziekenhuis Leuven · BEZiekenhuisnetwerk Antwerpen Stuivenberg · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFew studies thus far have compared head-to-head different non-myelooablative conditioning regimens for allogeneic hematopoietic cell transplantation (allo-HCT).

methodsHere, we report the results of a phase II multicenter randomized study comparing non-myeloablative allo-HCT from HLA-identical siblings (n = 54) or from 10/10 HLA-matched unrelated donors (n = 40) with either fludarabine plus 2 Gy total body irradiation (Flu-TBI arm; n = 49) or 8 Gy TLI + anti-thymocyte globulin (TLI-ATG arm; n = 45) conditioning.

resultsThe 180-day cumulative incidences of grade II-IV acute GVHD (primary endpoint) were 12.2% versus 8.9% in Flu-TBI and TLI-ATG patients, respectively (P = 0.5). Two-year cumulative incidences of moderate/severe chronic GVHD were 40.8% versus 17.8% in Flu-TBI and TLI-ATG patients, respectively (P = 0.017). Five Flu-TBI patients and 10 TLI-ATG patients received pre-emptive DLI for low donor chimerism levels, while 1 Flu-TBI patient and 5 TLI-ATG patients (including 2 patients given prior pre-emptive DLIs) received a second HCT for poor graft function, graft rejection, or disease progression. Four-year cumulative incidences of relapse/progression were 22% and 50% in Flu-TBI and TLI-ATG patients, respectively (P = 0.017). Four-year cumulative incidences of nonrelapse mortality were 24% and 13% in Flu-TBI and TLI-ATG patients, respectively (P = 0.5). Finally, 4-year overall (OS) and progression-free survivals (PFS) were 53% and 54%, respectively, in the Flu-TBI arm, versus 54% (P = 0.9) and 37% (P = 0.12), respectively, in the TLI-ATG arm.

conclusionsIn comparison to patients included in the Flu-TBI arm, patients included in the TLI-ATG arm had lower incidence of chronic GVHD, higher incidence of relapse and similar OS.

trial registrationThe study was registered on ClinicalTrial.gov ( NCT00603954 ) and EUDRACT (2010-024297-19) .

Indexed as

AdultAgedAllograftsAntilymphocyte SerumAntineoplastic AgentsChemoradiotherapyDisease-Free SurvivalFemaleGraft vs Host DiseaseHematologic NeoplasmsHematopoietic Stem Cell TransplantationHumansIncidenceMaleMaltoseMiddle AgedAntilymphocyte SerumAntineoplastic AgentsaurothiomaltosefludarabineMaltoseVidarabine

Identifiers

PMID25652604
PMCPMC4332717
OpenAlexW2130722192

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.