Evidence map›Paper›PMID 34677647›Full record

Trial reportCancer immunology, immunotherapy : CII2022

Efficacy and safety of Wilms' tumor 1 helper peptide OCV-501 in elderly patients with acute myeloid leukemia: a multicenter, randomized, double-blind, placebo-controlled phase 2 trial.

Toru Kiguchi, Masaki Yamaguchi, Naoki Takezako, Shuichi Miyawaki, Koichi Masui, Yuichiro Ihara, Masao Hirota, Naoko Shimofurutani, Tomoki Naoe

Open access · greenAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Cancer immunology, immunotherapy : CII, 2022. 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 37% 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, 6 citations in OpenAlex.

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

9 authors at 5 institutions in 1 country.

Toru KiguchiChugoku Central Hospital, Fukuyama, Japan. kiguchi-t@umin.ac.jp.ORCID http://orcid.org/0000-0003-2322-4798
Masaki YamaguchiIshikawa Prefectural Central Hospital, Kanazawa, Japan.
Naoki TakezakoNational Hospital Organization Disaster Medical Center of Japan, Tokyo, Japan.
Shuichi MiyawakiTokyo Metropolitan Ohtsuka Hospital, Tokyo, Japan.
Koichi MasuiOtsuka Pharmaceutical Co., Ltd, Osaka, Japan.
Yuichiro IharaOtsuka Pharmaceutical Co., Ltd, Tokushima, Japan.
Masao HirotaOtsuka Pharmaceutical Co., Ltd, Tokyo, Japan.
Naoko ShimofurutaniOtsuka Pharmaceutical Co., Ltd, Osaka, Japan.
Tomoki NaoeNational Hospital Organization Nagoya Medical Center, Nagoya, Japan.
Otsuka (Japan) · JPNational Hospital Organization · JPChugoku Central Hospital · JPIshikawa Prefectural Central Hospital · JPTokyo Metropolitan Ohtsuka Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeComplete remission (CR) of acute myeloid leukemia (AML) in elderly patients has a short duration, and there is no suitable post-remission therapy. We explored the role of the Wilms' tumor 1 helper peptide OCV-501 to prevent recurrence after remission.

methodsThis placebo-controlled phase 2 study was designed to evaluate accurately the efficacy and immunogenicity of OCV-501 in elderly AML patients. Elderly AML patients who achieved first CR were randomly allocated to receive either OCV-501 (N = 69) or placebo (N = 65) once a week for eight weeks and then every two weeks until week 104. The primary endpoint was disease-free survival (DFS).

resultsNineteen (27.5%) patients in the OCV-501 group and 23 (35.4%) patients in the placebo group completed the study without relapse. The median DFS in the OCV-501 and placebo groups was 12.1 and 8.4 months, respectively (p = 0.7671, hazard ratio [95% confidence interval]: 0.933 [0.590, 1.477]). The major drug adverse reactions were injection-site reactions. Although treatment with OCV-501 did not prolong DFS for elderly AML patients, post hoc analysis found that immune responders to OCV-501 whose specific IgG was > 10,000 ng/mL (N = 16) and whose WT1-specific interferon-γ response was > 10 pg/mL (N = 26) had significantly longer overall survival compared with placebo.

conclusionsThe placebo-controlled design of this study and quantitative immunological monitoring provides new insight into the relationship between peptide-induced immune responses and survival, suggesting future perspectives for cancer immunotherapy.

Indexed as

Leukemia, Myeloid, AcuteWT1 ProteinsAgedDisease-Free SurvivalHumansPeptidesRemission InductionPeptidesWT1 ProteinsAcute myeloid leukemiaElderlyImmunotherapyOCV-501Wilms’ tumor 1 helper peptide

Identifiers

PMID34677647
PMCPMC10992744
OpenAlexW3207531682

What OpenQuestion holds

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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.