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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Clínico 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kyowa Kirin Co., Ltd.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Kyowa Hakko Kirin Pharma, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 30, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2012

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 4, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 17, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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