Evidence map›Paper›PMID 25733162›Full record

Trial reportBritish journal of haematology2015

Dose-intensified chemotherapy alone or in combination with mogamulizumab in newly diagnosed aggressive adult T-cell leukaemia-lymphoma: a randomized phase II study.

Takashi Ishida, Tatsuro Jo, Shigeki Takemoto, Hitoshi Suzushima, Kimiharu Uozumi, Kazuhito Yamamoto, Naokuni Uike, Yoshio Saburi, Kisato Nosaka, Atae Utsunomiya and 11 more

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in British journal of haematology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 127 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
127citing papers in PubMed, 3 pooled it
12.6field-weighted citation impact, top 1% 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.

NCT01173887 phase2completednot on this map

Multicenter, Randomized, Open-label, Parallel-group Study to Compare mLSG15 + KW-0761 to mLSG15 in Subjects With CCR4-positive Adult T-cell Leukemia-lymphoma (Untreated Primary Disease)

TypeinterventionalSponsorKyowa Kirin Co., Ltd.Ran2010 to 2012Enrolled44ConditionsAdult T-cell Leukemia-LymphomaArmsVCAP/AMP/VECP(mLSG15), KW-0761
NCT05996185 phase2recruitingnot on this mapstarted 2024, after this paper: background citation

Phase II Study of Mogamulizumab With DA-EPOCH or CHOEP in Patients With Aggressive T-cell Lymphoma

TypeinterventionalSponsorYale UniversityRan2024 to 2027Enrolled22ConditionsT Cell Lymphoma, T-cell LymphomaArmsMogamulizumab, DA-EPOCH Protocol, CHOEP protocol
3 · Its place in the literature

Who cites it

127 citing papers in PubMed, 3 syntheses or guidelines pooled it, 258 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Revised Adult T-Cell Leukemia-Lymphoma International Consensus Meeting Report.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2019
    Guideline
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. MogamulizumabHaematologica · 2019
    Trial
  9. Trial
  10. Review
  11. Article
  12. Article
  13. Regulatory T cells in cancer and inflammation.Signal transduction and targeted therapy · 2026
    Review
  14. Review
  15. Article
  16. Review
  17. Review
  18. Article
  19. Review
  20. Article

67 more citing papers are in PubMed but not listed here.

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

21 authors at 18 institutions in 1 country.

Takashi IshidaDepartment of Haematology and Oncology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.
Tatsuro JoDepartment of Haematology, Japanese Red Cross Nagasaki Genbaku Hospital, Nagasaki, Japan.
Shigeki TakemotoDepartment of Haematology and Institute for Clinical Research, National Hospital Organization Kumamoto Medical Centre, Kumamoto, Japan.
Hitoshi SuzushimaDepartment of Haematology, Kumamoto Shinto General Hospital, Kumamoto, Japan.
Kimiharu UozumiDepartment of Haematology and Immunology, Kagoshima University Hospital, Kagoshima, Japan.
Kazuhito YamamotoDepartment of Haematology and Cell Therapy, Aichi Cancer Centre Hospital, Nagoya, Japan.
Naokuni UikeDepartment of Haematology, National Hospital Organization Kyushu Cancer Centre, Fukuoka, Japan.
Yoshio SaburiDepartment of Haematology, Oita Prefectural Hospital, Oita, Japan.
Kisato NosakaCancer Centre, Kumamoto University Hospital, Kumamoto, Japan.
Atae UtsunomiyaDepartment of Haematology, Imamura Bun-in Hospital, Kagoshima, Japan.
Kensei TobinaiDepartment of Haematology, National Cancer Centre Hospital, Tokyo, Japan.
Hiroshi FujiwaraDepartment of Bioregulatory Medicine, Ehime University Graduate School of Medicine, Toon, Japan.
Kenji IshitsukaDivision of Medical Oncology, Haematology, and Infectious Diseases, Department of Internal Medicine, Fukuoka University, Fukuoka, Japan.
Shinichiro YoshidaDepartment of Haematology, National Hospital Organization Nagasaki Medical Centre, Ohmura, Japan.
Naoya TairaDepartment of Internal Medicine, Heartlife Hospital, Okinawa, Japan.
Yukiyoshi MoriuchiDepartment of Haematology, Sasebo City General Hospital, Sasebo, Japan.
Kazunori ImadaDepartment of Haematology, Kokura Memorial Hospital, Kitakyushu, Japan.
Toshihiro MiyamotoDepartment of Medicine and Biosystemic Science, Kyushu University Graduate School of Medical Sciences, Fukuoka, Japan.
Shiro AkinagaKyowa Hakko Kirin Co., Ltd., Tokyo, Japan.
Masao TomonagaDepartment of Haematology, Japanese Red Cross Nagasaki Genbaku Hospital, Nagasaki, Japan.
Ryuzo UedaDepartment of Tumour Immunology, Aichi Medical University School of Medicine, Nagoya, Japan.
Japanese Red Cross Society, Japan · JPKumamoto University Hospital · JPNagoya City University · JPAichi Cancer Center · JPEhime University · JPFukuoka University · JPHeart Life Hospital · JPImamura Hospital · JPKagoshima University Hospital · JPKokura Memorial Hospital · JPKumamoto Medical Center · JPKyowa Kirin (Japan) · JPKyushu University · JPNagasaki Medical Center · JPNational Cancer Centre Japan · JPNational Hospital Organization Kyushu Cancer Center · JPOita Prefectural Hospital · JPSasebo City General Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This multicentre, randomized, phase II study was conducted to examine whether the addition of mogamulizumab, a humanized anti-CC chemokine receptor 4 antibody, to mLSG15, a dose-intensified chemotherapy, further increases efficacy without compromising safety of patients with newly diagnosed aggressive adult T-cell leukaemia-lymphoma (ATL). Patients were assigned 1:1 to receive mLSG15 plus mogamulizumab or mLSG15 alone. The primary endpoint was the complete response rate (%CR); secondary endpoints included the overall response rate (ORR) and safety. The %CR and ORR in the mLSG15-plus-mogamulizumab arm (n = 29) were 52% [95% confidence interval (CI), 33-71%] and 86%, respectively; the corresponding values in the mLSG15 arm (n = 24) were 33% (95% CI, 16-55%) and 75%, respectively. Grade ≥ 3 treatment-emergent adverse events, including anaemia, thrombocytopenia, lymphopenia, leucopenia and decreased appetite, were observed more frequently (≥10% difference) in the mLSG15-plus-mogamulizumab arm. Several adverse events, including skin disorders, cytomegalovirus infection, pyrexia, hyperglycaemia and interstitial lung disease, were observed only in the mLSG15-plus-mogamulizumab arm. Although the combination strategy showed a potentially less favourable safety profile, a higher %CR was achieved, providing the basis for further investigation of this novel treatment for newly diagnosed aggressive ATL. This study was registered at ClinicalTrials.gov, identifier: NCT01173887.

Indexed as

AdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarboplatinCyclophosphamideDisease ProgressionDoxorubicinEtoposideFemaleHumansLeukemia-Lymphoma, Adult T-CellMaleMiddle AgedNitrosourea CompoundsAntibodies, Monoclonal, HumanizedCarboplatinCyclophosphamideDoxorubicinEtoposidemogamulizumabNitrosourea CompoundsPrednisoloneVincristineVindesineadult T-cell leukaemia-lymphomaantibody therapyCCR4mogamulizumabrandomized phase II study

Identifiers

PMID25733162
PMCPMC5024033
OpenAlexW2148895451

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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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.