search
Back to results

Multicenter, Randomized, Open-label, Parallel-group Study to Compare mLSG15 + KW-0761 to mLSG15

Primary Purpose

Adult T-cell Leukemia-Lymphoma

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
VCAP/AMP/VECP(mLSG15)
KW-0761
Sponsored by
Kyowa Kirin Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adult T-cell Leukemia-Lymphoma

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects who have been positive for serum anti-human T-cell lymphotropic virus type I antibody
  • Subjects with hematologically or pathohistologically confirmed as peripheral lymphoid tumor which surface antigen analysis has identified to be of T-cell origin
  • Subjects who have been classified into acute subtype, the lymphoma subtype or chronic subtype with poor prognostic factors
  • Subjects who have been positive for CCR4 by CCR4 expression analysis
  • Subjects who have never been treated for adult T-cell leukemia-lymphoma
  • Subjects who have presented enlarged lymph nodes, tumor nodules in extranodal organs, abnormal lymphocytes in peripheral blood or cutaneous lesions
  • Subjects with a performance status of 0 to 2
  • Subjects who have been negative for HBs antigen and anti-HCV antibody
  • Subjects who have given written voluntary informed consent to participate in the study

Exclusion Criteria:

  • Subjects who are scheduled for transplant therapy such as hematopoietic stem-cell transplantation
  • Subjects who had myocardial infarction within 12 months before study enrollment or who have cardiac disease that may worsen during treatment with doxorubicin
  • Subjects who have been positive for anti-HIV antibody
  • Subjects with active multiple cancer
  • Subjects with a history of allergic reactions to therapeutic antibodies
  • Subjects who require emergency radiotherapy for treating the symptoms caused by bulky masses 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

Sites / Locations

  • Fukuoka University Hospital
  • Kyushu University Hospital
  • National Kyushu Cancer Center
  • Imamura Bun-in Hospital
  • Kagoshima University Hospital
  • Kokura Memorial Hospital
  • Kumamoto University Hospital
  • National Hospital Organization Kumamoto Medical Center
  • NTT West Japan Kyushu Hospital
  • Nagasaki University Hospital
  • The Japanese Red Cross Nagasaki Genbaku Hospital
  • Aichi Cancer Center Hospital
  • Nagoya City University Hospital
  • Oita Prefectural Hospital
  • Heartlife Hospital
  • National Hospital Organization Nagasaki Medical Center
  • Sasebo City General Hospital
  • National Cancer Center Hospital
  • Ehime University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

mLSG15

mLSG15 + KW-0761

Arm Description

Outcomes

Primary Outcome Measures

Complete response rate in the best overall response assessment for antitumor effect

Secondary Outcome Measures

Response rate in the best overall response assessment for antitumor effect, complete or response rates by lesion site in the best overall response assessment for antitumor effect
Progression-free survival and Overall survival
Adverse events
anti-KW-0761 antibody
Plasma KW-0761 concentrations and pharmacokinetic parameters

Full Information

First Posted
July 30, 2010
Last Updated
March 29, 2017
Sponsor
Kyowa Kirin Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT01173887
Brief Title
Multicenter, Randomized, Open-label, Parallel-group Study to Compare mLSG15 + KW-0761 to mLSG15
Official Title
Multicenter, Randomized, Open-label, Parallel-group Study to Compare mLSG15 + KW-0761 to mLSG15 in Subjects With CCR4-positive Adult T-cell Leukemia-lymphoma (Untreated Primary Disease)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kyowa Kirin Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This is a multicenter, randomized, open-label, parallel-group study to compare mLSG15 + KW-0761 to mLSG15 in subjects with CCR4-positive adult T-cell leukemia-lymphoma (untreated primary disease). The primary variable is an efficacy of KW-0761 used as an add-on therapy to mLSG15 as measured in terms of complete response rate (CR/CRu) in the best overall response assessment for antitumor effect. The secondary variables include response rate (CR/CRu/PR) in the best overall response assessment for antitumor effect, complete or response rates by lesion site in the best overall response assessment for antitumor effect, progression-free survival and overall survival. The safety and pharmacokinetic profiles of KW-0761 will be also determined.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult T-cell Leukemia-Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mLSG15
Arm Type
Active Comparator
Arm Title
mLSG15 + KW-0761
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
VCAP/AMP/VECP(mLSG15)
Intervention Description
VCAP(Vincristine Sulfate, Cyclophosphamide Hydrate, Doxorubicin Hydrochloride, Prednisolone); AMP(Doxorubicin Hydrochloride, Ranimustine, Prednisolone); VECP(Vindesine Sulfate, Etoposide, Carboplatin, Prednisolone)
Intervention Type
Biological
Intervention Name(s)
KW-0761
Intervention Description
VCAP/AMP/VECP(mLSG15) + KW-0761
Primary Outcome Measure Information:
Title
Complete response rate in the best overall response assessment for antitumor effect
Time Frame
After cycle 2 and cycle 4
Secondary Outcome Measure Information:
Title
Response rate in the best overall response assessment for antitumor effect, complete or response rates by lesion site in the best overall response assessment for antitumor effect
Time Frame
After cycle 2 and cycle 4.
Title
Progression-free survival and Overall survival
Time Frame
During the study period at least once every two months in the first year and once every three months in the second and subsequent years.
Title
Adverse events
Time Frame
During the study period
Title
anti-KW-0761 antibody
Time Frame
Before 1st and 5th dosing, 14 days after 8th or last dosing and at the start of post-treatment.
Title
Plasma KW-0761 concentrations and pharmacokinetic parameters
Time Frame
Before and after 1st, 2nd, 3rd, 4th, 5th, 6th, 7th and 8th dosing, 14 days after 8th or last dosing, and at the start of post-treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects who have been positive for serum anti-human T-cell lymphotropic virus type I antibody Subjects with hematologically or pathohistologically confirmed as peripheral lymphoid tumor which surface antigen analysis has identified to be of T-cell origin Subjects who have been classified into acute subtype, the lymphoma subtype or chronic subtype with poor prognostic factors Subjects who have been positive for CCR4 by CCR4 expression analysis Subjects who have never been treated for adult T-cell leukemia-lymphoma Subjects who have presented enlarged lymph nodes, tumor nodules in extranodal organs, abnormal lymphocytes in peripheral blood or cutaneous lesions Subjects with a performance status of 0 to 2 Subjects who have been negative for HBs antigen and anti-HCV antibody Subjects who have given written voluntary informed consent to participate in the study Exclusion Criteria: Subjects who are scheduled for transplant therapy such as hematopoietic stem-cell transplantation Subjects who had myocardial infarction within 12 months before study enrollment or who have cardiac disease that may worsen during treatment with doxorubicin Subjects who have been positive for anti-HIV antibody Subjects with active multiple cancer Subjects with a history of allergic reactions to therapeutic antibodies Subjects who require emergency radiotherapy for treating the symptoms caused by bulky masses 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
Facility Information:
Facility Name
Fukuoka University Hospital
City
Fukuoka
Country
Japan
Facility Name
Kyushu University Hospital
City
Fukuoka
Country
Japan
Facility Name
National Kyushu Cancer Center
City
Fukuoka
Country
Japan
Facility Name
Imamura Bun-in Hospital
City
Kagoshima
Country
Japan
Facility Name
Kagoshima University Hospital
City
Kagoshima
Country
Japan
Facility Name
Kokura Memorial Hospital
City
Kitakyushu
Country
Japan
Facility Name
Kumamoto University Hospital
City
Kumamoto
Country
Japan
Facility Name
National Hospital Organization Kumamoto Medical Center
City
Kumamoto
Country
Japan
Facility Name
NTT West Japan Kyushu Hospital
City
Kumamoto
Country
Japan
Facility Name
Nagasaki University Hospital
City
Nagasaki
Country
Japan
Facility Name
The Japanese Red Cross Nagasaki Genbaku Hospital
City
Nagasaki
Country
Japan
Facility Name
Aichi Cancer Center Hospital
City
Nagoya
Country
Japan
Facility Name
Nagoya City University Hospital
City
Nagoya
Country
Japan
Facility Name
Oita Prefectural Hospital
City
Oita
Country
Japan
Facility Name
Heartlife Hospital
City
Okinawa
Country
Japan
Facility Name
National Hospital Organization Nagasaki Medical Center
City
Omura
Country
Japan
Facility Name
Sasebo City General Hospital
City
Sasebo
Country
Japan
Facility Name
National Cancer Center Hospital
City
Tokyo
Country
Japan
Facility Name
Ehime University Hospital
City
Toon
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
25733162
Citation
Ishida T, Jo T, Takemoto S, Suzushima H, Uozumi K, Yamamoto K, Uike N, Saburi Y, Nosaka K, Utsunomiya A, Tobinai K, Fujiwara H, Ishitsuka K, Yoshida S, Taira N, Moriuchi Y, Imada K, Miyamoto T, Akinaga S, Tomonaga M, Ueda R. Dose-intensified chemotherapy alone or in combination with mogamulizumab in newly diagnosed aggressive adult T-cell leukaemia-lymphoma: a randomized phase II study. Br J Haematol. 2015 Jun;169(5):672-82. doi: 10.1111/bjh.13338. Epub 2015 Mar 2.
Results Reference
derived

Learn more about this trial

Multicenter, Randomized, Open-label, Parallel-group Study to Compare mLSG15 + KW-0761 to mLSG15

We'll reach out to this number within 24 hrs