Clinical Trial VICCHEM1284
Open-Label, Multi-Center, Randomized Study of Anti-CCR4 Monoclonal Antibody KW 0761 (mogamulizumab) Versus Vorinostat in Subjects with Previously Treated Cutaneous T-Cell Lymphoma
- Protocol No. VICCHEM1284
- Open Date: 06/05/2013
- Staging: Phase III
- Age Group: Adults
- Scope: National
- Objective: To compare the progression free survival of KW-0761 versus vorinostat for subjects with relapsed or refractory CTCL.
- Disease Sites: Lymphoma
- Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
- Drugs: None Specified
- Participating Institutions: Vanderbilt University
- National Clinical Trial ID: NCT01728805
- Secondary Protocol No: 0761-010
Patients with refractory Cutaneous T-Cell Lymphoma (CTCL) are being invited to participate in this study. The main purpose of this study is to find out if KW-0761, an investigational drug, will work against cutaneous T-cell lymphoma (CTCL) that has failed to respond to other treatments, and to evaluate its side effects. An investigational drug is one which has not been approved by the U.S. Food and Drug Administration (FDA). Currently, KW-0761 is approved by the Government Health Agency in Japan for use in patients with another type of T-cell lymphoma. KW-0761 is an antibody. Antibodies are proteins which the immune system, the bodys defense system, uses to recognize foreign or unwanted material, such as infection or some cancers. Antibodies are used to try to destroy cancer cells while causing little harm to normal cells. The cancer cells of many patients with T-cell lymphoma contain a protein called CCR4. KW-0761 is an antibody that finds T-cells that have a protein called CCR4 on their surface and attempts to destroy them. KW-0761 will be tested in this study versus vorinostat which is a drug that has been approved by the US FDA for treatment of CTCL.
|Ages Eligible for Study:||18 Years and older|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
• Males and female subjects ≥ 18 years of age at the time of enrollment, except in Japan where subjects must be ≥ 20 years of age at the time of enrollment
• Histologically confirmed diagnosis of mycosis fungoides (MF) or Sezary Syndrome (SS)
• Stage IB, II-A, II-B, III and IV
• Subjects who have failed at least one prior course of systemic therapy. Psoralen plus ultraviolet light therapy (PUVA) is not considered to be a systemic therapy
• Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 1 at study entry
• Resolution of all clinically significant toxic effects of prior cancer therapy to grade ≤1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 (NCI-CTCAE, v.4.0)
• Adequate hematological, renal and hepatic function
• Subjects previously treated with anti-CD4 antibody or alemtuzumab are eligible provided their CD4+ cell counts are ≥ 200/mm3
• Subjects with mycosis fungoides (MF) and a known history of non-complicated staphylococcus infection/colonization are eligible provided they continue to receive stable doses of prophylactic antibiotics
• Women of childbearing potential (WOCBP) must have a negative pregnancy test within 7 days of receiving study medication
• WOCBP and male subjects as well as their female partners of childbearing potential must agree to use effective contraception throughout the study
• Prior treatment with KW-0761 or vorinostat.
• Large cell transformation. However, subjects with a history of LCT but without current aggressive disease and no current evidence of LCT on pathology in skin and lymph nodes would be eligible.
• Diagnosed with a malignancy in the past two years. However, subjects with non-melanoma skin cancers, melanoma in situ, localized cancer of the prostate with current PSA of <0.1 ng/mL, treated thyroid cancer or cervical carcinoma in situ or ductal/lobular carcinoma in situ of the breast within the past two years may enroll as long as there is no current evidence of disease.
• Clinical evidence of central nervous system (CNS) metastasis.
• Psychiatric illness, disability or social situation that would compromise the subject's safety or ability to provide consent, or limit compliance with study requirements.
• Significant uncontrolled intercurrent illness
• Known or tests positive for human immunodeficiency virus (HIV), human T-cell leukemia virus (HTLV-1), hepatitis B or hepatitis C.
• Active herpes simplex or herpes zoster. Subjects on prophylaxis for herpes who started taking medication at least 30 days prior to study entry, and have no active signs of active infection, and whose last active infection was more than 6 months ago, may enter the study, and should continue to take the prescribed medication for the duration of the study.
• Experienced allergic reactions to monoclonal antibodies or other therapeutic proteins.
• Known active autoimmune disease will be excluded. (For example, Grave's disease; systemic lupus erythematosus; rheumatoid arthritis; Crohn's disease; psoriasis).
• Is pregnant (confirmed by beta human chorionic gonadotrophin [β-HCG]) or lactating.