Evidence map›Paper›PMID 37589942›Full record

ArticleAnnals of hematology2023

Safety of romiplostim administered immediately after cord-blood transplantation: a phase 1 trial.

Naoki Kurita, Hidekazu Nishikii, Yumiko Maruyama, Yasuhito Suehara, Keiichiro Hattori, Tatsuhiro Sakamoto, Takayasu Kato, Yasuhisa Yokoyama, Naoshi Obara, Kazushi Maruo and 8 more

Abstract readClinical Trial, Phase I
PubMed Publisher
In one paragraph

Article in Annals of hematology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.6field-weighted citation impact, top 27% 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

2 citing papers in PubMed, 2 citations in OpenAlex.

  1. Trial
  2. 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

18 authors at 2 institutions in 1 country.

Naoki KuritaDepartment of Hematology, Institute of Medicine, University of Tsukuba, Tennodai 1-1-1, Tsukuba, Ibaraki, 305-8575, Japan. kuripon@mvb.biglobe.ne.jp.ORCID http://orcid.org/0000-0002-1283-4307
Hidekazu NishikiiDepartment of Hematology, Institute of Medicine, University of Tsukuba, Tennodai 1-1-1, Tsukuba, Ibaraki, 305-8575, Japan.
Yumiko MaruyamaDepartment of Hematology, University of Tsukuba Hospital, Tsukuba, Japan.
Yasuhito SueharaDepartment of Hematology, University of Tsukuba Hospital, Tsukuba, Japan.
Keiichiro HattoriDepartment of Hematology, Institute of Medicine, University of Tsukuba, Tennodai 1-1-1, Tsukuba, Ibaraki, 305-8575, Japan.
Tatsuhiro SakamotoDepartment of Hematology, Institute of Medicine, University of Tsukuba, Tennodai 1-1-1, Tsukuba, Ibaraki, 305-8575, Japan.
Takayasu KatoDepartment of Hematology, Institute of Medicine, University of Tsukuba, Tennodai 1-1-1, Tsukuba, Ibaraki, 305-8575, Japan.
Yasuhisa YokoyamaDepartment of Hematology, Institute of Medicine, University of Tsukuba, Tennodai 1-1-1, Tsukuba, Ibaraki, 305-8575, Japan.
Naoshi ObaraDepartment of Hematology, Institute of Medicine, University of Tsukuba, Tennodai 1-1-1, Tsukuba, Ibaraki, 305-8575, Japan.
Kazushi MaruoTsukuba Clinical Research & Development Organization, University of Tsukuba, Tsukuba, Japan.
Tomohiro OhigashiTsukuba Clinical Research & Development Organization, University of Tsukuba, Tsukuba, Japan.
Hitomi YamaguchiTsukuba Clinical Research & Development Organization, University of Tsukuba, Tsukuba, Japan.
Toshiro IwamotoTsukuba Clinical Research & Development Organization, University of Tsukuba, Tsukuba, Japan.
Hideto MinoharaTsukuba Clinical Research & Development Organization, University of Tsukuba, Tsukuba, Japan.
Ryota MatsuokaDepartment of Diagnostic Pathology, Institute of Medicine, University of Tsukuba, Tsukuba, Japan.
Koichi HashimotoTsukuba Clinical Research & Development Organization, University of Tsukuba, Tsukuba, Japan.
Mamiko Sakata-YanagimotoDepartment of Hematology, Institute of Medicine, University of Tsukuba, Tennodai 1-1-1, Tsukuba, Ibaraki, 305-8575, Japan.
Shigeru ChibaDepartment of Hematology, Institute of Medicine, University of Tsukuba, Tennodai 1-1-1, Tsukuba, Ibaraki, 305-8575, Japan.
University of Tsukuba · JPUniversity of Tsukuba Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Graft failure and delayed hematopoietic recovery are the major limitations of cord-blood transplantation (CBT). Romiplostim, a thrombopoietin-receptor agonist, promotes megakaryopoiesis and multilineage hematopoiesis in aplastic anemia. The decreased number of hematopoietic stem cells in the early phase after CBT and aplastic anemia share certain characteristics. Therefore, we hypothesized that romiplostim administration immediately after CBT may promote multilineage hematopoietic recovery. We investigated the safety and preliminary efficacy of administering romiplostim a day after CBT. This phase 1 dose-escalation study included six adults with hematologic malignancies in remission. Romiplostim was administered subcutaneously within 7 days after single-unit CBT, initially at doses of 5 µg/kg or 10 µg/kg in three patients, then once a week for 14 weeks or until platelet recovery. The maximum dose was 20 µg/kg. The median number of romiplostim administrations was 6 (range, 3-15). Romiplostim-related adverse events included bone pain (3/6) and injection site reaction (1/6). Non-hematological grade ≥ 3 toxicities were observed in four patients; febrile neutropenia was the most common (4/6). All patients achieved neutrophil engraftment and the median time was 14 days (range, 12-32). Platelet counts ≥ 50 × 10

Indexed as

Anemia, AplasticHematopoietic Stem Cell TransplantationAdultHumansNeoplasm Recurrence, LocalReceptors, FcRecombinant Fusion ProteinsThrombopoietinReceptors, FcRecombinant Fusion ProteinsromiplostimThrombopoietinCord-blood transplantationHematopoietic recoveryRomiplostimThrombopoietin-receptor agonist

Identifiers

PMID37589942
OpenAlexW4385898775

What OpenQuestion holds

Textmetadata
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.