NCT01173887

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)

Completed Phase 2 Last updated 29 March 2017

What this trial tests

Phase 2 trial testing VCAP/AMP/VECP(mLSG15) in Adult T-cell Leukemia-Lymphoma in 44 participants. Completed in 1 April 2012.

Timeline

1 July 2010

Primary endpoint
1 April 2012

1 April 2012

Quick facts

Lead sponsor	Kyowa Kirin Co., Ltd.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	44
Start date	1 July 2010
Primary completion	1 April 2012
Estimated completion	1 April 2012
Sites	19 locations across Japan

Drugs / interventions tested

• VCAP/AMP/VECP(mLSG15) — full drug profile →
• KW-0761 — full drug profile →

Conditions studied

• Adult T-cell Leukemia-Lymphoma — all drugs for Adult T-cell Leukemia-Lymphoma →

Sponsor

Kyowa Kirin Co., Ltd. — full company profile →

Who can join

20 and older, any sex, with Adult T-cell Leukemia-Lymphoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Complete response rate in the best overall response assessment for antitumor effect
  Time frame: After cycle 2 and cycle 4

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting cytokine and chemokine signaling pathways for cancer therapy.
   Yi M, Li T, Niu M, Zhang H, et al · · 2024 · cited 264× · PMID 39034318 · DOI 10.1038/s41392-024-01868-3
2. Dose-intensified chemotherapy alone or in combination with mogamulizumab in newly diagnosed aggressive adult T-cell leukaemia-lymphoma: a randomized phase II study.
   Ishida T, Jo T, Takemoto S, Suzushima H, et al · · 2015 · cited 192× · PMID 25733162 · DOI 10.1111/bjh.13338
3. Pharmacological modulation of chemokine receptor function.
   Scholten DJ, Canals M, Maussang D, Roumen L, et al · · 2012 · cited 190× · PMID 21699506 · DOI 10.1111/j.1476-5381.2011.01551.x
4. Advances in targeted therapy for malignant lymphoma.
   Wang L, Qin W, Huo YJ, Li X, et al · · 2020 · cited 88× · PMID 32296035 · DOI 10.1038/s41392-020-0113-2
5. Chemokine receptor-specific antibodies in cancer immunotherapy: achievements and challenges.
   Vela M, Aris M, Llorente M, Garcia-Sanz JA, et al · · 2015 · cited 79× · PMID 25688243 · DOI 10.3389/fimmu.2015.00012
6. Targeting chemokine receptor CCR4 in adult T-cell leukemia-lymphoma and other T-cell lymphomas.
   Tobinai K, Takahashi T, Akinaga S. · · 2012 · cited 33× · PMID 22538464 · DOI 10.1007/s11899-012-0124-3
7. Safety and efficacy profile of mogamulizumab (Poteligeo) in the treatment of cancers: an update evidence from 14 studies.
   Zhang T, Sun J, Li J, Zhao Y, et al · · 2021 · cited 27× · PMID 34039310 · DOI 10.1186/s12885-021-08363-w
8. Clinical and Real-World Effectiveness of Mogamulizumab: A Narrative Review.
   Fernández-Guarino M, Ortiz P, Gallardo F, Llamas-Velasco M. · · 2024 · cited 12× · PMID 38396877 · DOI 10.3390/ijms25042203