Evidence map›Paper›PMID 30087460›Full record

Trial reportBone marrow transplantation2019

Myeloablative and reduced-intensity conditioning in HLA-haploidentical peripheral blood stem cell transplantation using post-transplant cyclophosphamide.

Junichi Sugita, Yusuke Kagaya, Toshihiro Miyamoto, Yasuhiko Shibasaki, Koji Nagafuji, Shuichi Ota, Tatsuo Furukawa, Miho Nara, Koichi Akashi, Shuichi Taniguchi and 4 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Bone marrow transplantation, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03654703 (Improved Post-Transplant Cyclophosphamide Regimens for Unmanipulated Haploidentical Transplant in Pediatric Patients With Refractory Acute Myeloid Leukemia), which is not on this map. Cited by 42 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
42citing 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.

NCT03654703 phase2unknown statusnot on this map

Improved Post-Transplant Cyclophosphamide Regimens for Unmanipulated Haploidentical Transplant in Pediatric Patients With Refractory Acute Myeloid Leukemia

TypeinterventionalSponsorCapital Research Institute of PediatricsRan2015 to 2020Enrolled100ConditionsHematopoietic System--CancerArmsCyclophosphamide
3 · Its place in the literature

Who cites it

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

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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.

Junichi SugitaHematology, Faculty of Medicine, Hokkaido University, Sapporo, Japan.
Yusuke KagayaHematology, Japanese Red Cross Nagoya First Hospital, Nagoya, Japan.
Toshihiro MiyamotoHematology/Oncology, Kyushu University Hospital, Fukuoka, Japan.
Yasuhiko ShibasakiStem Cell Transplantation, Niigata University Medical and Dental Hospital, Niigata, Japan.
Koji NagafujiHematology and Oncology, Kurume University School of Medicine, Kurume, Japan.
Shuichi OtaHematology, Sapporo Hokuyu Hospital, Sapporo, Japan.
Tatsuo FurukawaHematology, Nagaoka Red Cross Hospital, Nagaoka, Japan.
Miho NaraHematology/Nephrology/Rheumatology, Akita University Hospital, Akita, Japan.
Koichi AkashiHematology/Oncology, Kyushu University Hospital, Fukuoka, Japan.
Shuichi TaniguchiHematology, Toranomon Hospital, Tokyo, Japan.
Mine HaradaKaratsu Higashimatsuura Medical Center, Karatsu, Japan.
Keitaro MatsuoMolecular and Clinical Epidemiology, Aichi Cancer Center Research Institute, Nagoya, Japan.ORCID 0000-0003-1761-6314
Takanori TeshimaHematology, Faculty of Medicine, Hokkaido University, Sapporo, Japan. teshima@med.hokudai.ac.jp.ORCID 0000-0002-0941-271X
Japan Study Group for Cell Therapy and Transplantation (JSCT)

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

We conducted two parallel prospective, multicenter, phase II studies to evaluate the safety and efficacy of HLA-haploidentical peripheral blood stem cell transplantation using post-transplant cyclophosphamide (PTCy-haploPBSCT) following myeloablative conditioning (MAC, n = 50) and reduced-intensity conditioning (RIC, n = 77). Event-free survival (EFS) at 1-year as for primary endpoint was 64% and 43% in the MAC and RIC groups, respectively. Neutrophil engraftment was achieved in 98% and 94% in the MAC and RIC groups, respectively. The incidences of grades II-IV and III-IV acute graft-versus-host disease (GVHD) were 18% and 8% in the MAC group, and 14% and 5% in the RIC group, respectively. Those of all grade and moderate to severe chronic GVHD at 2-year were 36% and 20% in the MAC group, and 27% and 20% in the RIC group, respectively. Overall survival (OS), EFS, nonrelapse mortality, and relapse rate at 2-year were 68%, 54%, 10%, and 36% in the MAC group, and 44%, 35%, 20%, and 45% in the RIC group, respectively. Notably, 83% and 86% of patients who survived without relapse stopped immunosuppressant at 2-year in the MAC and RIC groups, respectively. Our results indicate that both MAC and RIC are valid options for PTCy-haploPBSCT for adults with hematological malignancies.

Indexed as

AdolescentAdultAgedCyclophosphamideFemaleHematopoietic Stem Cell TransplantationHumansImmunosuppressive AgentsMaleMiddle AgedPeripheral Blood Stem Cell TransplantationProspective StudiesTransplantation ConditioningYoung AdultCyclophosphamideImmunosuppressive Agents

Identifiers

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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.