Study of KW-0761 (Mogamulizumab) in Subjects With Previously Treated Peripheral T-cell Lymphoma (PTCL)

June 14, 2024 updated by: Kyowa Kirin Co., Ltd.

Open-Label, Multi-Center, Phase 2 Study of Anti-CCR4 Monoclonal Antibody KW-0761 (Mogamulizumab) in Subjects With Previously Treated Peripheral T-cell Lymphoma (PTCL)

The primary objective of this study is to determine the overall response rate of KW-0761 for the treatment of patients with relapsed or refractory PTCL. KW-0761 targets CCR4. CCR4 is the receptor for macrophage derived chemokines MDC/CCL22 and TARC/CCL17. Chemokines are considered to play a role both in the recruitment of immune and inflammatory cells for anti-tumor response and in the selective homing of neoplastic B and T cells.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PTCL is a rare and heterogeneous disease that remains difficult to diagnose and treat. In the majority of PTCL subtypes, patients are of older age (>60 years) and present with advanced stage disease.With the exception of the ALCL-ALK-positive subtype that responds well to CHOP combined chemotherapy, most PTCL subtypes become refractory even to aggressive chemotherapy regimens or relapse. Overall survival of PTCL patients is poor compared with that of aggressive B-cell lymphomas.Thus, novel and effective therapies are needed.KW-0761(mogamulizumab) is a defucosylated, humanized, IgG1 mAb with enhanced antibody dependent cellular cytotoxicity (ADCC)that binds to CCR4, a molecule that is suggested to be significantly involved in patients with PTCL.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Aarhus University Hospital
  • France
      • Créteil Cedex, France, 94010
        • CHU Henri Mondor
      • Lille Cedex, France, 59037
        • CHRU Lille
      • Paris, France, 75010
        • Hôpital Saint-Louis
      • Pierre Benite, France, 69310
        • Centre Hospitaliser de Lyon Sud
      • Rouen, France, 76038
        • Centre Henri Becquerel
  • Italy
      • Bologna, Italy
        • Universita di Bologna
  • Netherlands
      • Amsterdam, Netherlands, 1081 HV
        • Vrije Universiteit Medisch Centrum (Vumc)
      • Groningen, Netherlands, 9713 GZ
        • Universitair Medisch Centrum Groningen (UMCG)
  • Spain
      • Barcelona, Spain, 08908
        • Institut Catalá D'Oncologia, Hospital Duran y Reynals
      • Madrid, Spain, 28041
        • Hospital Univesitario 12 de Octubre
      • Salamanca, Spain, 37191
        • Hospital Clinico Universitario de Salamanca
  • United Kingdom
      • London, United Kingdom, SE1 9RT
        • Guy's Hospital
      • Manchester, United Kingdom, M20 4BX
        • Christie Hospital
      • SouthHampton, United Kingdom, SO16 6YD
        • Cancer Research UK Centre/Southhampton General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. ≥18 years of age at the time of enrollment;

  2. Histologically confirmed diagnosis of PTCL as specified below:

    • PTCL-NOS
    • Angioimmunoblastic T-cell lymphoma
    • Anaplastic large cell lymphoma, ALK-positive
    • Anaplastic large cell lymphoma, ALK-negative
    • Transformed mycosis fungoides
  3. Failed or intolerant of at least one prior systemic anticancer therapy;
  4. ECOG performance status score of ≤ 2 at study entry;
  5. At least one site of disease measurable in two dimensions by computed tomography (CT);
  6. Subjects who are positive for CCR4 by immunohistochemistry;
  7. Resolution of all clinically significant toxic effects of prior cancer therapy to grade ≤1 (NCI-CTCAE, v.4.0);
  8. Adequate hematological hepatic and renal function.

Exclusion Criteria:

  1. Subject with the following PTCL diagnoses are excluded;

    • Precursor T/NK neoplasms
    • Adult T-cell leukemia-lymphoma
    • T-cell prolymphocytic leukemia
    • T-cell large granular lymphocytic leukemia
    • Aggressive NK-cell leukemia
    • Systemic EBV-positive T-cell lymphoproliferative disorder of childhood
    • Hydroa vacciniforme-like lymphoma
    • Mycosis fungoides, other than transformed mycosis fungoides
    • Sezary Syndrome
    • Primary cutaneous CD30+ disorders: Anaplastic large cell lymphoma and lymphatoid papulosis
    • Primary cutaneous CD8+ aggressive epidermotropic cytoxic T-cell lymphoma
    • Primary cutaneous CD4+ small/medium T-cell lymphoma
    • Primary cutaneous gamma-delta T-cell lymphoma
    • Extranodal NK/T T-cell lymphoma-nasal type
    • Enteropathy-associated T-cell lymphoma
    • Hepatosplenic T-cell lymphoma
    • Subcutaneous panniculitis -like T-cell lymphoma
    • Chronic lymphoproliferative disorder of NK cells
  2. Have had an invasive solid tumor malignancy in the past five years except non-melanoma skin cancers, melanoma in situ, cervical carcinoma in situ, ductal/lobular carcinoma in situ of the breast, or localized prostate cancer with a current PSA of ≤ 0.1 ng/ml who is currently without evidence of disease;
  3. Relapsed less than 75 days of autologous stem cell transplant;
  4. History of allogeneic stem cell transplant;
  5. Evidence of central nervous system (CNS) metastasis;
  6. Psychiatric illness, disability or social situation that would compromise the subject's safety or ability to provide consent, or limit compliance with study requirements;
  7. Subjects with a history of moderate or severe psoriasis or with psoriasis associated with systemic symptoms e.g. arthropathy), or with a 1st degree relative with history of psoriasis that required medical intervention;
  8. Significant uncontrolled intercurrent illness;
  9. Known or tests positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C;
  10. Active herpes simplex or herpes zoster;
  11. Experienced allergic reactions to monoclonal antibodies or other therapeutic proteins;
  12. Known active autoimmune disease will be excluded (For example: Grave's disease; systemic lupus erythematosus; rheumatoid arthritis; Crohn's disease);
  13. Is pregnant (confirmed by beta human chorionic gonadotrophin [β-HCG]) or lactating; Prohibited Therapies and/or Medications
  14. Prior treatment with KW-0761;
  15. Initiation of treatment with systemic steroids while on study is only permitted for acute and brief complications of underlying disease (e.g., hypercalcemia) or for treatment related side effects;
  16. Initiation of treatment with topical steroids while on study is not permitted except to treat an acute rash;
  17. Have had anti-neoplastic chemotherapy, radiation, immunotherapy, or investigational medications within 4 weeks of screening visit;
  18. Subjects on any immunomodulatory drug.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: KW-0761
Biological: KW-0761 (mogamulizumab)
1 mg/kg administered intravenously weekly x 4 then every other week until progression
Other Names:
  • mogamulizumab
  • POTELIGEO®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Response Rate
Time Frame: every 8 weeks
every 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyowa Kirin Co., Ltd.

Collaborators

Kyowa Hakko Kirin Pharma, Inc.

Investigators

  • Principal Investigator: Pier Luigi Zinzani, M.D., PhD, Universita di Bologna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

May 30, 2012

First Submitted That Met QC Criteria

June 1, 2012

First Posted (Estimated)

June 4, 2012

Study Record Updates

Last Update Posted (Actual)

June 17, 2024

Last Update Submitted That Met QC Criteria

June 14, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROTOCOL 0761-007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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