Evidence map›Paper›PMID 25703164›Full record

Trial reportEuropean journal of haematology2016

OCTET-CY: a phase II study to investigate the efficacy of post-transplant cyclophosphamide as sole graft-versus-host prophylaxis after allogeneic peripheral blood stem cell transplantation.

Udo Holtick, Jens-Markus Chemnitz, Alexander Shimabukuro-Vornhagen, Sebastian Theurich, Geothy Chakupurakal, Anke Krause, Anne Fiedler, Leo Luznik, Martin Hellmich, Dominik Wolf and 3 more

Abstract readClinical Trial, Phase II
In one paragraph

Trial report in European journal of haematology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing 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.

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

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

  1. Post-transplant cyclophosphamideFrontiers in oncology · 2023
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  9. Alternative-Donor Hematopoietic Stem Cell Transplantation with Post-Transplantation Cyclophosphamide for Nonmalignant Disorders.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

5 · Who and what money

Authors and funding

13 authors.

Udo HoltickStem Cell Transplantation Program, Department I of Internal Medicine, Center for Integrated Oncology CIO KölnBonn, University Hospital of Cologne, Cologne, Germany.
Jens-Markus ChemnitzStem Cell Transplantation Program, Department I of Internal Medicine, Center for Integrated Oncology CIO KölnBonn, University Hospital of Cologne, Cologne, Germany.
Alexander Shimabukuro-VornhagenStem Cell Transplantation Program, Department I of Internal Medicine, Center for Integrated Oncology CIO KölnBonn, University Hospital of Cologne, Cologne, Germany.
Sebastian TheurichStem Cell Transplantation Program, Department I of Internal Medicine, Center for Integrated Oncology CIO KölnBonn, University Hospital of Cologne, Cologne, Germany.
Geothy ChakupurakalStem Cell Transplantation Program, Department I of Internal Medicine, Center for Integrated Oncology CIO KölnBonn, University Hospital of Cologne, Cologne, Germany.
Anke KrauseStem Cell Transplantation Program, Department I of Internal Medicine, Center for Integrated Oncology CIO KölnBonn, University Hospital of Cologne, Cologne, Germany.
Anne FiedlerCologne Interventional Immunology, Department I of Internal Medicine, University Hospital of Cologne, Cologne, Germany.
Leo LuznikSidney Kimmel Comprehensive Cancer Center and Department of Oncology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Martin HellmichInstitute of Medical Statistics, Informatics and Epidemiology, University of Cologne, Cologne, Germany.
Dominik WolfMedical Clinic III for Oncology, Haematology and Rheumatology, Center for Integrated Oncology CIO KölnBonn, University Hospital Bonn, Bonn, Germany.
Michael HallekStem Cell Transplantation Program, Department I of Internal Medicine, Center for Integrated Oncology CIO KölnBonn, University Hospital of Cologne, Cologne, Germany.
Michael von Bergwelt-BaildonStem Cell Transplantation Program, Department I of Internal Medicine, Center for Integrated Oncology CIO KölnBonn, University Hospital of Cologne, Cologne, Germany.
Christof ScheidStem Cell Transplantation Program, Department I of Internal Medicine, Center for Integrated Oncology CIO KölnBonn, University Hospital of Cologne, Cologne, Germany.

Funding

Translational Research Central ServicesP30CA006973 · NCI · JOHNS HOPKINS UNIVERSITY · PI WILLIAM George NELSON · 1985 to 2026
$208.6M
NCI NIH HHS P30 CA006973
6 · The paper itself

Abstract

objectivePost-transplant cyclophosphamide is increasingly used as graft-versus-host disease (GvHD) prophylaxis in the setting of bone marrow transplantation. No data have been published on the use of single-agent GvHD prophylaxis with post-transplant cyclophosphamide in the setting of peripheral blood stem cell transplantation (PBSCT).

methodsIn a phase II trial, 11 patients with myeloma or lymphoma underwent conditioning with fludarabine and busulfan followed by T-replete PBSCT and application of 50 mg/kg/d of cyclophosphamide on day+3 and +4 without other concurrent immunosuppression (IS).

resultsMedian time to leukocyte, neutrophil, and platelet engraftment was 18, 21, and 18 d. The incidence of grade II-IV and grade III-IV GvHD was 45% and 27%, with a non-relapse mortality (NRM) of 36% at one and 2 yr. After median follow-up of 927 d, overall and relapse-free survival was 64% and 34%. Three patients did not require any further systemic IS until day+100 and thereafter. Analysis of immune reconstitution demonstrated rapid T- and NK-cell recovery. B- and CD3+/CD161+NK/T-cell recovery was superior in patients not receiving additional IS.

conclusionPost-transplant cyclophosphamide as sole IS in PBSCT is feasible and allows rapid immune recovery. Increased rates of severe acute GvHD explain the observed NRM and may advise a temporary combination partner such as mTor-inhibitors in the PBSCT setting.

Indexed as

Peripheral Blood Stem Cell TransplantationAdultAllograftsCyclophosphamideFemaleGraft vs Host DiseaseHematologic NeoplasmsHumansMaleMiddle AgedCyclophosphamideallogeneic hematopoietic stem cell transplantationgraft-versus-host diseasepost-transplant cyclophosphamide

Identifiers

PMID25703164
PMCPMC4844370

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Registered trials

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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.