Adult T-cell Leukemia-Lymphoma
Conditions
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.
Interventions
DRUGVCAP/AMP/VECP(mLSG15)
VCAP(Vincristine Sulfate, Cyclophosphamide Hydrate, Doxorubicin Hydrochloride, Prednisolone); AMP(Doxorubicin Hydrochloride, Ranimustine, Prednisolone); VECP(Vindesine Sulfate, Etoposide, Carboplatin, Prednisolone)
BIOLOGICALKW-0761
VCAP/AMP/VECP(mLSG15) + KW-0761
Sponsors
Kyowa Kirin Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response rate in the best overall response assessment for antitumor effect | After cycle 2 and cycle 4 |
Secondary
| Measure | Time frame |
|---|---|
| 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 | After cycle 2 and cycle 4. |
| Progression-free survival and Overall survival | 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. |
| Adverse events | During the study period |
| anti-KW-0761 antibody | Before 1st and 5th dosing, 14 days after 8th or last dosing and at the start of post-treatment. |
| Plasma KW-0761 concentrations and pharmacokinetic parameters | 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. |
Countries
Japan
Outcome results
None listed