Clinical trial · Interventional
Multicenter, Randomized, Open-label, Parallel-group Study to Compare mLSG15 + KW-0761 to mLSG15
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult T-cell Leukemia-Lymphoma | Adult T-Cell Leukemia/Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| KW-0761 | Biological | Mogamulizumab | ALIAS |
| VCAP/AMP/VECP(mLSG15) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- mLSG15
- interventionNames
- Drug: VCAP/AMP/VECP(mLSG15)
- type
- EXPERIMENTAL
- label
- mLSG15 + KW-0761
- interventionNames
- Biological: KW-0761
Primary outcomes (1)
- measure
- Complete response rate in the best overall response assessment for antitumor effect
- timeFrame
- After cycle 2 and cycle 4
Secondary outcomes (5)
- measure
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDIshida 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. PMID 25733162