Study of KW-0761 in Subjects With CCR4-positive Peripheral T/NK-cell Lymphoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier:
NCT01192984
First received: August 30, 2010
Last updated: September 11, 2014
Last verified: September 2014

August 30, 2010
September 11, 2014
September 2010
May 2012   (final data collection date for primary outcome measure)
Antitumor effect (best overall response) [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01192984 on ClinicalTrials.gov Archive Site
  • Antitumor effect (best response by disease lesion), progression-free survival and overall survival [ Designated as safety issue: No ]
  • Adverse events and anti-KW-0761 antibody levels [ Designated as safety issue: Yes ]
  • Plasma KW-0761 concentrations and pharmacokinetic parameters [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of KW-0761 in Subjects With CCR4-positive Peripheral T/NK-cell Lymphoma
Phase II Study of KW-0761 in Subjects With CCR4-positive Peripheral T/NK-cell Lymphoma

The purpose of this study is to evaluate the efficacy of KW-0761 intravenously administered eight times at one-week intervals in patients with CCR4-positive peripheral T/NK-cell lymphoma. The primary objective is to assess the antitumor effect in terms of best overall response, while the secondary objectives are to assess the antitumor effect in terms of best response by disease lesion, to assess the progression-free survival and to assess the overall survival. The safety and pharmacokinetic profiles of KW-0761 will be also evaluated.

Not Provided
Interventional
Phase 2
Primary Purpose: Treatment
Peripheral T/NK-cell Lymphoma
Biological: KW-0761
Intravenously 8 times at 1-week intervals
Experimental: KW-0761
Intervention: Biological: KW-0761
Ogura M, Ishida T, Hatake K, Taniwaki M, Ando K, Tobinai K, Fujimoto K, Yamamoto K, Miyamoto T, Uike N, Tanimoto M, Tsukasaki K, Ishizawa K, Suzumiya J, Inagaki H, Tamura K, Akinaga S, Tomonaga M, Ueda R. Multicenter phase II study of mogamulizumab (KW-0761), a defucosylated anti-cc chemokine receptor 4 antibody, in patients with relapsed peripheral T-cell lymphoma and cutaneous T-cell lymphoma. J Clin Oncol. 2014 Apr 10;32(11):1157-63. doi: 10.1200/JCO.2013.52.0924. Epub 2014 Mar 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
May 2012
May 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects with hematologically or pathohistologically diagnosed peripheral T/NK-cell lymphoma
  • Subjects who have been positive for CCR4
  • Subjects who received one or more chemotherapy regimens
  • Subjects who relapse after achieving complete response, uncertain complete response or partial response by the last chemotherapy
  • Subjects who have an interval of 4 weeks or more between the last day of the prior therapy and the scheduled day of the first KW-0761 treatment
  • Subjects with nodal lesions, extranodal lesions and/or cutaneous lesions
  • Subjects who have a performance status of 0 to 2
  • Subjects who are negative for HBs antigen and reported as "not detected" for HBV-DNA
  • Subjects who are negative for anti-HCV antibody
  • Subjects who have normal function of the major organs
  • Subjects who have given written voluntary informed consent to participate in the study

Exclusion Criteria:

  • Subjects who underwent transplant therapy such as hematopoietic stem-cell transplantation (Subjects who underwent autologous hematopoietic stem-cell transplantation following chemotherapy will not be excluded)
  • Subjects who are known carriers of HIV
  • Subjects who have active multiple cancer
  • Subjects who have a history of allergic reactions to therapeutic antibodies
  • Subjects requiring continuous systemic treatment with steroid
  • Subjects who require emergency radiotherapy for treating the symptoms caused by bulky masses at enrollment or who may require such radiotherapy after the start of the study
  • Subjects who are pregnant, lactating or of childbearing potential, or who are planning to have children
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01192984
0761-004
Not Provided
Kyowa Hakko Kirin Company, Limited
Kyowa Hakko Kirin Company, Limited
Not Provided
Not Provided
Kyowa Hakko Kirin Company, Limited
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP