Study of KW-0761 (Mogamulizumab) in Subjects With Previously Treated Peripheral T-cell Lymphoma (PTCL) | Not Recruiting
Study of KW-0761 (Mogamulizumab) in Subjects With Previously Treated Peripheral T-cell Lymphoma (PTCL)
Health Conditions
  • Peripheral T-Cell Lymphoma
Not Recruiting
Recruitment Status
NCT01611142
Primary Trial ID Number
Summary
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.
Primary Outcome Measures
  • Overall Response Rate; every 8 weeks
Secondary Outcome Measures
    Sorry, this information is not available
Research Question
  • 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.
Design Type
Sorry, this information is not available
Ethics Approval
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Publications
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Countries of Recruitment
Denmark; France; Germany; Italy; Netherlands; Spain; United Kingdom
Participant Sex
Both
Participant Age Range
18 Years to N/A
Participant Type
Sorry, this information is not available
Trial Sample Size
35
Participant Inclusion 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.
Participant Exclusion 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.
Interventions
Biological; KW-0761 (mogamulizumab); 1 mg/kg administered intravenously weekly x 4 then every other week until progression; [KW-0761]
Design Details
Sorry, this information is not available
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Results Reporting
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Acronym
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Scientific 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)
Secondary Trial Identifying Number
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Website
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Study Funded By
Kyowa Hakko Kirin Pharma, Inc.
Funder Type
Sorry, this information is not available
Study Sponsored By
Kyowa Hakko Kirin Pharma, Inc.
Study Also Sponsored By
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Primary Sponsor Type
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Secondary Sponsor Type
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Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

30 May 2012

Last Updated

01 Apr 2015

Date Record Refreshed on UKCTG

24 Jul 2015