Multicenter, Randomized, Open-label, Parallel-group Study to Compare mLSG15 + KW-0761 to mLSG15
This study has been completed.
Sponsor:
Kyowa Hakko Kirin Company, Limited
Information provided by:
Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier:
NCT01173887
First received: July 30, 2010
Last updated: March 26, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Adult T-cell Leukemia-Lymphoma |
Drug: VCAP/AMP/VECP(mLSG15) Biological: KW-0761 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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) |
Resource links provided by NLM:
Further study details as provided by Kyowa Hakko Kirin Company, Limited:
Primary Outcome Measures:
- Complete response rate in the best overall response assessment for antitumor effect [ Designated as safety issue: No ]
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 [ Designated as safety issue: No ]
- Adverse events and anti-KW-0761 antibody [ Designated as safety issue: Yes ]
- Plasma KW-0761 concentrations and pharmacokinetic parameters [ Designated as safety issue: No ]
| Study Start Date: | July 2010 |
| Study Completion Date: | April 2012 |
| Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: mLSG15 |
Drug: VCAP/AMP/VECP(mLSG15)
VCAP(Vincristine Sulfate, Cyclophosphamide Hydrate, Doxorubicin Hydrochloride, Prednisolone); AMP(Doxorubicin Hydrochloride, Ranimustine, Prednisolone); VECP(Vindesine Sulfate, Etoposide, Carboplatin, Prednisolone)
|
| Experimental: mLSG15 + KW-0761 |
Biological: KW-0761
VCAP/AMP/VECP(mLSG15) + KW-0761
|
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01173887
Locations
| Japan | |
| Fukuoka University Hospital | |
| Fukuoka, Japan | |
| Kyushu University Hospital | |
| Fukuoka, Japan | |
| National Kyushu Cancer Center | |
| Fukuoka, Japan | |
| Kagoshima University Hospital | |
| Kagoshima, Japan | |
| Imamura Bun-in Hospital | |
| Kagoshima, Japan | |
| Kokura Memorial Hospital | |
| Kitakyushu, Japan | |
| National Hospital Organization Kumamoto Medical Center | |
| Kumamoto, Japan | |
| NTT West Japan Kyushu Hospital | |
| Kumamoto, Japan | |
| Kumamoto University Hospital | |
| Kumamoto, Japan | |
| Nagasaki University Hospital | |
| Nagasaki, Japan | |
| The Japanese Red Cross Nagasaki Genbaku Hospital | |
| Nagasaki, Japan | |
| Aichi Cancer Center Hospital | |
| Nagoya, Japan | |
| Nagoya City University Hospital | |
| Nagoya, Japan | |
| Oita Prefectural Hospital | |
| Oita, Japan | |
| Heartlife Hospital | |
| Okinawa, Japan | |
| National Hospital Organization Nagasaki Medical Center | |
| Omura, Japan | |
| Sasebo City General Hospital | |
| Sasebo, Japan | |
| National Cancer Center Hospital | |
| Tokyo, Japan | |
| Ehime University Hospital | |
| Toon, Japan | |
Sponsors and Collaborators
Kyowa Hakko Kirin Company, Limited
More Information
No publications provided
| Responsible Party: | Clinical Science Department, Kyowa Hakko Kirin Company, Limited |
| ClinicalTrials.gov Identifier: | NCT01173887 History of Changes |
| Other Study ID Numbers: | 0761-003 |
| Study First Received: | July 30, 2010 |
| Last Updated: | March 26, 2013 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Additional relevant MeSH terms:
|
Leukemia Leukemia, T-Cell Leukemia-Lymphoma, Adult T-Cell Lymphoma Neoplasms by Histologic Type Neoplasms |
Leukemia, Lymphoid Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013