Evidence map›Paper›PMID 25605368›Full record

Trial reportBlood2015

Phase 1/2 study of mogamulizumab, a defucosylated anti-CCR4 antibody, in previously treated patients with cutaneous T-cell lymphoma.

Madeleine Duvic, Lauren C Pinter-Brown, Francine M Foss, Lubomir Sokol, Jeffrey L Jorgensen, Pramoda Challagundla, Karen M Dwyer, Xiaoping Zhang, Michael R Kurman, Rocco Ballerini and 2 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Blood, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00888927 (Open-Label, Multi-Center, Dose Escalation Phase 1/2 Study of Anti-CCR4 Monoclonal Antibody KW-0761 as Monotherapy in Subjects With Previously Treated Peripheral T-Cell Lymphoma), which is not on this map. Cited by 98 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
98citing papers in PubMed, 1 pooled it
32.2field-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.

NCT00888927 phase1 / phase2completednot on this map

Open-Label, Multi-Center, Dose Escalation Phase 1/2 Study of Anti-CCR4 Monoclonal Antibody KW-0761 as Monotherapy in Subjects With Previously Treated Peripheral T-Cell Lymphoma

TypeinterventionalSponsorKyowa Kirin Co., Ltd.Ran2009 to 2012Enrolled42ConditionsPeripheral T-Cell LymphomaArmsKW-0761
3 · Its place in the literature

Who cites it

98 citing papers in PubMed, 1 synthesis or guideline pooled it, 228 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Review
  7. Review
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  15. Review
  16. Article
  17. Clinical and Real-World Effectiveness of Mogamulizumab: A Narrative Review.International journal of molecular sciences · 2024
    Review
  18. Article
  19. Article
  20. Review

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 5 institutions in 1 country.

Madeleine DuvicMD Anderson Cancer Center, Houston, TX;
Lauren C Pinter-BrownUniversity of California, Los Angeles, CA;
Francine M FossSmilow Cancer Center at Yale New Haven Hospital, New Haven, CT;
Lubomir SokolH. Lee Moffitt Cancer Center and Research Institute, Tampa, FL;
Jeffrey L JorgensenMD Anderson Cancer Center, Houston, TX;
Pramoda ChallagundlaMD Anderson Cancer Center, Houston, TX;
Karen M DwyerKyowa Hakko Kirin Pharma Inc, Princeton, NJ;
Xiaoping ZhangKyowa Hakko Kirin Pharma Inc, Princeton, NJ;
Michael R KurmanKyowa Hakko Kirin Pharma Inc, Princeton, NJ;
Rocco BalleriniKyowa Hakko Kirin Pharma Inc, Princeton, NJ;
Li LiuReSearch Pharmaceutical Services, Inc, Fort Washington, PA; and.
Youn H KimStanford Cancer Center, Stanford, CA.
Kirin (United States) · USThe University of Texas MD Anderson Cancer Center · USMoffitt Cancer Center · USSmilow Cancer Hospital · USUniversity of California, Los Angeles · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
6 · The paper itself

Abstract

This phase 1/2 study evaluated the efficacy of mogamulizumab, a defucosylated, humanized, anti-CC chemokine receptor 4 monoclonal antibody, in 41 pretreated patients with cutaneous T-cell lymphoma. No dose-limiting toxicity was observed and the maximum tolerated dose was not reached in phase 1 after IV infusion of mogamulizumab (0.1, 0.3, and 1.0 mg/kg) once weekly for 4 weeks followed by a 2-week observation. In phase 2, patients were dosed with 1.0 mg/kg mogamulizumab according to the same schedule for the first course followed by infusion every 2 weeks during subsequent courses until disease progression. The most frequent treatment-emergent adverse events were nausea (31.0%), chills (23.8%), headache (21.4%), and infusion-related reaction (21.4%); the majority of events were grade 1/2. There were no significant hematologic effects. Among 38 evaluable patients, the overall response rate was 36.8%: 47.1% in Sézary syndrome (n = 17) and 28.6% in mycosis fungoides (n = 21). Eighteen of 19 (94.7%) patients with ≥B1 blood involvement had a response in blood, including 11 complete responses. Given the safety and efficacy of mogamulizumab, phase 3 investigation of mogamulizumab is warranted in cutaneous T-cell lymphoma patients. This trial was registered at www.clinicaltrials.gov as #NCT00888927.

Indexed as

AdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedDrug Administration ScheduleFemaleHumansLymphoma, T-Cell, CutaneousMaleMaximum Tolerated DoseMiddle AgedMycosis FungoidesPrognosisReceptors, CCR4Sezary SyndromeTreatment OutcomeAntibodies, Monoclonal, HumanizedCCR4 protein, humanmogamulizumabReceptors, CCR4

Identifiers

PMID25605368
PMCPMC4375715
OpenAlexW2002994195

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.