Evidence map›Paper›PMID 29384978›Full record

ArticleMedicine2017

Efficacy and safety of autologous peripheral blood stem cell transplantation for Philadelphia chromosome-positive acute lymphoblastic leukemia: A study protocol for a multicenter exploratory prospective study (Auto-Ph17 study).

Satoshi Nishiwaki, Isamu Sugiura, Yasuhiko Miyata, Shigeki Saito, Masashi Sawa, Tetsuya Nishida, Koichi Miyamura, Yachiyo Kuwatsuka, Akio Kohno, Masaaki Yuge and 9 more

Open access · goldAbstract readMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Medicine, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.5field-weighted citation impact, top 25% 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.

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

4 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Article
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

19 authors at 10 institutions in 1 country.

Satoshi NishiwakiCenter for Advanced Medicine and Clinical Research, Nagoya University Hospital, Nagoya Division of Hematology and Oncology, Toyohashi Municipal Hospital, Toyohashi Department of Hematology, National Hospital Organization Nagoya Medical Center Department of Hematology and Oncology, Japanese Red Cross Nagoya Daini Hospital, Nagoya Department of Hematology, Anjo Kosei Hospital, Anjo Department of Hematology and Oncology, Nagoya University Graduate School of Medicine Department of Hematology, Japanese Red Cross Nagoya Daiichi Hospital, Nagoya Department of Hematology and Oncology, JA Aichi Konan Kosei Hospital, Konan Division of Hematology, Ichinomiya Municipal Hospital, Ichinomiya Department of Immunology, Nagoya University Graduate School of Medicine, Nagoya, Japan.
Isamu Sugiura
Yasuhiko Miyata
Shigeki Saito
Masashi Sawa
Tetsuya Nishida
Koichi Miyamura
Yachiyo Kuwatsuka
Akio Kohno
Masaaki Yuge
Masanobu Kasai
Hiroatsu Iida
Shingo Kurahashi
Masahide Osaki
Tatsunori Goto
Seitaro Terakura
Makoto Murata
Hiroyoshi Nishikawa
Hitoshi Kiyoi
Nagoya University · JPJapanese Red Cross Nagoya Daiichi Hospital · JPJapanese Red Cross Nagoya Daini Hospital · JPToyohashi Municipal Hospital · JPAnjo Kosei Hospital · JPIchinomiya Municipal City Hospital · JPKonan Kosei Hospital · JPNagoya Medical Center · JPNagoya University Hospital · JPNational Hospital Organization · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe prognosis of Philadelphia chromosome positive acute lymphoblastic leukemia (Ph + ALL) has been dramatically improved since the introduction of tyrosine kinase inhibitors (TKIs). Although allogeneic hematopoietic cell transplantation (allo-HCT) is a major treatment option, the role of autologous peripheral blood stem cell transplantation (auto-PBSCT) has been reconsidered, especially in patients who achieved early molecular remission. METHODS AND ANALYSIS: This is a multicenter exploratory study for Ph + ALL patients aged between 55 and 70 years who achieved complete molecular remission within 3 cycles of chemotherapy. The target sample size is 5, and the registration period is 2 years. The primary endpoint is Day100- mortality after transplantation, and the secondary endpoints are survival, relapse rate, nonrelapse mortality, and adverse events.This study is divided into 3 phases: peripheral blood stem cell harvest, transplantation, and maintenance. Chemomobilization is performed using a combination of cyclophosphamide (CPM), doxorubicin, vincristine (VCR), and prednisolone (PSL). As a preparative regimen, the LEED regimen is used, which consists of melphalan, CPM, etoposide, and dexamethasone. Twelve cycles of maintenance therapy using a combination of VCR, PSL, and dasatinib are performed.In association with relapse, the minimal residual disease (MRD) of BCR-ABL chimeric gene and T-cell subsets are analyzed both before and after auto-PBSCT. ETHICS AND DISSEMINATION: The protocol was approved by the institutional review board of Nagoya University Hospital and all the participating hospitals. Written informed consent was obtained from all patients before registration, in accordance with the Declaration of Helsinki. Results of the study will be disseminated via publications in peer-reviewed journals.

trial registrationTrial registration number UMIN000026445.

Indexed as

Philadelphia ChromosomeAgedDisease ProgressionFemaleGenes, ablHumansImmunosuppressive AgentsMaleMiddle AgedPeripheral Blood Stem Cell TransplantationPrecursor Cell Lymphoblastic Leukemia-LymphomaProspective StudiesProto-Oncogene Proteins c-bcrResearch DesignSurvival AnalysisBCR protein, humanImmunosuppressive AgentsProto-Oncogene Proteins c-bcr

Identifiers

PMID29384978
PMCPMC6393033
OpenAlexW2779512393

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.