Trial record 3 of 10 for:    kw-0761

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Kyowa Hakko Kirin Pharma, Inc.
ClinicalTrials.gov Identifier:
NCT01611142
First received: May 30, 2012
Last updated: February 12, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Peripheral T-Cell Lymphoma
Biological: KW-0761 (mogamulizumab)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Kyowa Hakko Kirin Pharma, Inc.:

Primary Outcome Measures:
  • Overall Response Rate [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 35
Study Start Date: April 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01611142

Locations
Denmark
Aarhus University Hospital
Aarhus, Denmark, 8000
France
CHU Henri Mondor
Créteil Cedex, France, 94010
CHRU Lille
Lille Cedex, France, 59037
Hopital Saint-Louis
Paris, France, 75010
Centre Hospitaliser de Lyon Sud
Pierre Benite, France, 69310
Centre Henri Becquerel
Rouen, France, 76038
Italy
Università di Bologna
Bologna, Italy
Netherlands
Vrije Universiteit Medisch Centrum (VUMC)
Amsterdam, Netherlands, 1081 HV
Universitair Medisch Centrum Groningen (UMCG)
Groningen, Netherlands, 9713 GZ
Spain
Institut Catalá D`Oncologia, Hospital Duran y Reynals
Barcelona, Spain, 08908
Hospital Univesitario 12 de Octubre
Madrid, Spain, 28041
Hospital Clínico Universitario de Salamanca
Salamanca, Spain, 37191
United Kingdom
Guy's Hospital
London, United Kingdom, SE1 9RT
Christie Hospital
Manchester, United Kingdom, M20 4BX
Cancer Research UK Centre/Southhampton General Hospital
SouthHampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
Kyowa Hakko Kirin Pharma, Inc.
Investigators
Principal Investigator: Pier Luigi Zinzani, M.D., PhD Universita di Bologna
  More Information

No publications provided

Responsible Party: Kyowa Hakko Kirin Pharma, Inc.
ClinicalTrials.gov Identifier: NCT01611142     History of Changes
Other Study ID Numbers: PROTOCOL 0761-007
Study First Received: May 30, 2012
Last Updated: February 12, 2014
Health Authority: United States: Food and Drug Administration
Denmark: Danish Medicines Agency
Germany: Paul-Ehrlich-Institut
Italy: Ethics Committee
Spain: Agencia Española de Medicamentos y Productos Sanitarios
United Kingdom: Medicines and Healthcare Products Regulatory Agency
France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Kyowa Hakko Kirin Pharma, Inc.:
Monoclonal antibody
Peripheral T-cell Lymphoma
cancer
hematologic malignancy

Additional relevant MeSH terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014