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

Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Medical Conditions
  • Peripheral T-Cell Lymphoma
Unfortunately contact details are not available for this trial.
Primary Contact Details
Completed
Recruitment Status
NCT01611142
Primary Trial ID Number
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information, or it may still be awaited from the organisation running the trial. Please look again in a few days if the information you need is not here, or contact the researcher named above.
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.
Research Details
  • 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.
Phase
Phase 2
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Type
Interventional
Intervention
Biological : KW-0761 (mogamulizumab)

Study Arm Groups : KW-0761

Intervention Type
See Interventions above
Primary Outcome Measures
  • Overall Response Rate; every 8 weeks
Secondary Outcome Measures
    Sorry, this information is not available
Publication(s)
Sorry, this information is not available
Result Reports
This is available on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information, or it may still be awaited from the organisation running the trial. Please look again in a few days if the information you need is not here, or contact the researcher named above.
Gender
Both
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
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
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information, or it may still be awaited from the organisation running the trial. Please look again in a few days if the information you need is not here, or contact the researcher named above.
Trial Location(s)
Manchester
M20 4BX
Guy's Hospital
London
SE1 9RT
Cancer Research UK Centre/Southhampton General Hospital
SouthHampton
SO16 6YD
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Denmark, France, Italy, Netherlands, Spain, United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information, or it may still be awaited from the organisation running the trial. Please look again in a few days if the information you need is not here, or contact the researcher named above.
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)
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
PROTOCOL 0761-007
Sponsor(s)
Kyowa Hakko Kirin Pharma, Inc.
Key Dates

Recruitment Start Date

Mar 2012

Recruitment End Date

May 2015

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

29 May 2012

Last Updated

30 Aug 2015

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