Evidence map›Paper›PMID 26729448›Full record

Trial reportBritish journal of haematology2016

The addition of sirolimus to the graft-versus-host disease prophylaxis regimen in reduced intensity allogeneic stem cell transplantation for lymphoma: a multicentre randomized trial.

Philippe Armand, Haesook T Kim, Marie-Michele Sainvil, Paulina B Lange, Angela A Giardino, Veronika Bachanova, Steven M Devine, Edmund K Waller, Neera Jagirdar, Alex F Herrera and 8 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in British journal of haematology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00928018 (A Phase III Multicenter, Randomized Trial Comparing Tacrolimus/Sirolimus/Methotrexate Versus Tacrolimus/Methotrexate or Cyclosporine/Mycophenolate Mofetil for GVHD Prophylaxis After Reduced Intensity Allogeneic Stem Cell Transplantation for Patients With Lymphoma), which is not on this map. Cited by 37 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 2 pooled it
–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.

NCT00928018 phase3completednot on this map

A Phase III Multicenter, Randomized Trial Comparing Tacrolimus/Sirolimus/Methotrexate Versus Tacrolimus/Methotrexate or Cyclosporine/Mycophenolate Mofetil for GVHD Prophylaxis After Reduced Intensity Allogeneic Stem Cell Transplantation for Patients With Lymphoma

TypeinterventionalSponsorDana-Farber Cancer InstituteRan2009 to 2014Enrolled139ConditionsNon-hodgkin Lymphoma, Hodgkin LymphomaArmsSirolimus, Methotrexate, Tacrolimus, Cyclosporine, MMF
3 · Its place in the literature

Who cites it

37 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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  7. Sirolimus and Mycophenolate Mofetil as Calcineurin Inhibitor-Free Graft-versus-Host Disease Prophylaxis for Reduced-Intensity Conditioning Umbilical Cord Blood Transplantation.Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2016
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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

18 authors.

Philippe ArmandDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
Haesook T KimBiostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, MA, USA.
Marie-Michele SainvilDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
Paulina B LangeDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
Angela A GiardinoDepartment of Radiology, Brigham and Women's Hospital, Boston, MA, USA.
Veronika BachanovaDepartment of Medical Oncology, University of Minnesota, Minneapolis, MN, USA.
Steven M DevineDepartment of Medicine, The Ohio State University Comprehensive Cancer Center Ohio State University, Columbus, OH, USA.
Edmund K WallerDepartment of Hematology/Oncology, Winship Cancer Institute, Emory University, Atlanta, GA, USA.
Neera JagirdarDepartment of Hematology/Oncology, Winship Cancer Institute, Emory University, Atlanta, GA, USA.
Alex F HerreraCity of Hope Cancer Center, Duarte, CA, USA.
Corey CutlerDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
Vincent T HoDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
John KorethDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
Edwin P AlyeaDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
Steven L McAfeeBone Marrow Transplant Unit, Division of Hematology/Oncology, Massachusetts General Hospital, Boston, MA, USA.
Robert J SoifferDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
Yi-Bin ChenBone Marrow Transplant Unit, Division of Hematology/Oncology, Massachusetts General Hospital, Boston, MA, USA.
Joseph H AntinDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.

Funding

University of Minnesota Clinical and Translational Science Institute (UMN CTSI)UL1TR000114 · NCATS · UNIVERSITY OF MINNESOTA · PI BLAZAR, BRUCE R · 2012 to 2015
$35.0M
Project 3: Humoral Targets and B Cell Biology in Chronic Graft-vs.-Host DiseaseP01CA142106 · NCI · DANA-FARBER CANCER INST · PI BLAZAR, BRUCE R · 2009 to 2019
$17.5M
Reconstitution of Regulatory T Cells after Allogeneic Stem Cell TransplantationU19AI029530 · NIAID · DANA-FARBER CANCER INSTITUTE · PI SOIFFER, ROBERT JON · 2005 to 2010
$9.0M
University of Minnesota Clinical and Translational Science Institute (UMN CTSI)KL2TR000113 · NCATS · UNIVERSITY OF MINNESOTA · PI BLAZAR, BRUCE R · 2012 to 2015
$5.4M
Manipulation of Immune Responsiveness after Hematopoietic Cell TransplantationR01CA183559 · NCI · DANA-FARBER CANCER INST · PI RITZ, JEROME, SOIFFER, ROBERT JON · 2013 to 2017
$3.7M
University of Minnesota Clinical and Translational Science Institute (UMN CTSI)KL2RR033182 · NCRR · UNIVERSITY OF MINNESOTA · PI BLAZAR, BRUCE R · 2011 to 2011
$1.4M
NCATS NIH HHS KL2 TR000113NCATS NIH HHS UL1 TR000114NCI NIH HHS P01 CA142106NCI NIH HHS R01 CA183559NCRR NIH HHS KL2 RR033182NIAID NIH HHS U19 AI029530
6 · The paper itself

Abstract

Inhibition of the mechanistic target of rapamycin (mTOR) pathway has clinical activity in lymphoma. The mTOR inhibitor sirolimus has been used in the prevention and treatment of graft-versus-host disease (GVHD) after allogeneic haematopoietic stem cell transplantation (HSCT). A retrospective study suggested that patients with lymphoma undergoing reduced intensity conditioning (RIC) HSCT who received sirolimus as part of their GVHD prophylaxis regimen had a lower rate of relapse. We therefore performed a multicentre randomized trial comparing tacrolimus, sirolimus and methotrexate to standard regimens in adult patients undergoing RIC HSCT for lymphoma in order to assess the possible benefit of sirolimus on HSCT outcome. 139 patients were randomized. There was no difference overall in 2-year overall survival, progression-free survival, relapse, non-relapse mortality or chronic GVHD. However, the sirolimus-containing arm had a significantly lower incidence of grade II-IV acute GVHD (9% vs. 25%, P = 0·015), which was more marked for unrelated donor grafts. In conclusion, the addition of sirolimus for GVHD prophylaxis in RIC HSCT is associated with no increased overall toxicity and a lower risk of acute GVHD, although it does not improve survival; this regimen is an acceptable option for GVHD prevention in RIC HSCT. This trial is registered at clinicaltrials.gov (NCT00928018).

Indexed as

Hematopoietic Stem Cell TransplantationAdolescentAdultAgedAllograftsFemaleGraft vs Host DiseaseHumansLymphomaMaleMethotrexateMiddle AgedSirolimusTacrolimusTransplantation ConditioningMethotrexateSirolimusTacrolimusclinical trialsGVHDlymphomasstem cell transplantation

Identifiers

PMID26729448
PMCPMC4809783

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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.