Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

Summary

The purpose of this study is to compare the progression free survival of KW-0761 versus vorinostat for subjects with relapsed or refractory CTCL.

Official Title

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

Details

Phase 3 randomized study to compare the progression free survival of subjects with relapsed/refractory CTCL who receive KW-0761 versus those who receive vorinostat. Subjects who progress on vorinostat will be allowed to cross over to KW-0761 upon progression.

Keywords

Cutaneous T-Cell Lymphoma Cutaneous T-Cell Lymphoma (CTCL) myocis fungoides (MF) Sezary Syndrome (SS) Lymphoma Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Vorinostat Mogamulizumab

Eligibility

You can join if…

Open to people ages 18 years and up

  • Male 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 had 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 were eligible provided their CD4+ cell counts were ≥ 200/mm3
  • Subjects with mycosis fungoides (MF) and a known history of non-complicated staphylococcus infection/colonization were eligible provided they continued to receive stable doses of prophylactic antibiotics
  • Women of childbearing potential (WOCBP) must have had 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 have agreed to use effective contraception throughout the study and for 3 months after the last dose of KW-0761

You CAN'T join if...

  • 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 could enroll as long as there was no current evidence of disease.
  • Clinical evidence of central nervous system (CNS) metastasis.
  • Psychiatric illness, disability or social situation that would have compromised the subject's safety or ability to provide consent, or limited compliance with study requirements.
  • Significant uncontrolled intercurrent illness
  • Known or tested 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 had no active signs of active infection, and whose last active infection was more than 6 months ago, could enter the study, and should have continued 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 were excluded. (For example, Grave's disease; systemic lupus erythematosus; rheumatoid arthritis; Crohn's disease; psoriasis).
  • Was pregnant (confirmed by beta human chorionic gonadotrophin [β-HCG]) or lactating.
  • History of allogeneic transplant.

Locations

  • UCLA Medical Center
    Los Angeles California 90095 United States
  • City of Hope National Medical Center
    Duarte California 91010 United States
  • Stanford Medical Center
    Stanford California 94305 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Kyowa Kirin Pharmaceutical Development, Inc.
ID
NCT01728805
Phase
Phase 3
Study Type
Interventional
Last Updated