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CompletedNCT01173887Updated Mar 30, 2017

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

A Phase 2 interventional study of VCAP/AMP/VECP(mLSG15) and KW-0761 in Adult T-cell Leukemia-Lymphoma, sponsored by Kyowa Kirin Co., Ltd.. Completed at 19 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2017-03-30.

Sponsored by Kyowa Kirin Co., Ltd. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Adult T-cell Leukemia-Lymphoma
03

In context

Leukemia-Lymphoma, Adult T-Cell

116 studies on the registry are indexed under Leukemia-Lymphoma, Adult T-Cell; 4 are open to participants now.

This study's enrollment of 44 is above the median of 32 across 104 interventional studies indexed under Leukemia-Lymphoma, Adult T-Cell.

Browse Leukemia-Lymphoma, Adult T-Cell studies →

Lead sponsor

Kyowa Kirin Co., Ltd. is the lead sponsor of 159 studies on the registry; 9 are open to participants now.

Browse Kyowa Kirin Co., Ltd. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
44 participants (actual)

Study arms

  • Active comparator
    mLSG15

    Drug: VCAP/AMP/VECP(mLSG15)

  • Experimental
    mLSG15 + KW-0761

    Biological: KW-0761

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

06

What researchers measure

Primary outcomes

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

    Time frame: After cycle 2 and cycle 4

Secondary outcomes

  1. 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.

  2. 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.

  3. Adverse events

    Time frame: During the study period

  4. 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.

  5. 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.

07

Study locations

19 sites
  • Fukuoka University Hospital
    Fukuoka, Japan
  • Kyushu University Hospital
    Fukuoka, Japan
  • National Kyushu Cancer Center
    Fukuoka, Japan
  • Imamura Bun-in Hospital
    Kagoshima, Japan
  • Kagoshima University Hospital
    Kagoshima, Japan
  • Kokura Memorial Hospital
    Kitakyushu, Japan
  • Kumamoto University Hospital
    Kumamoto, Japan
  • National Hospital Organization Kumamoto Medical Center
    Kumamoto, Japan
  • NTT West Japan Kyushu 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
  • Heartlife Hospital
    Okinawa, Japan
  • Oita Prefectural Hospital
    Ōita, Japan
  • National Hospital Organization Nagasaki Medical Center
    Ōmura, Japan
  • Sasebo City General Hospital
    Sasebo, Japan
  • National Cancer Center Hospital
    Tokyo, Japan
  • Ehime University Hospital
    Tōon, Japan
08

References and documents

Publications

  • 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. PubMed 25733162 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01173887
Lead sponsor
Kyowa Kirin Co., Ltd.
Responsible party
Sponsor
First posted
Aug 2, 2010
Start date
Jul 2010
Primary completion
Apr 2012
Completion
Apr 2012
Last update
Mar 30, 2017

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Mogamulizumab

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