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Adult T-cell Leukemia-LymphomaPhase 2NCT01173887

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

A Phase 2 study testing VCAP/AMP/VECP(mLSG15) and KW-0761 in people with Adult T-cell Leukemia-Lymphoma, run by Kyowa Kirin Co., Ltd. at 19 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Adult T-cell Leukemia-Lymphoma
What is being tested?
VCAP/AMP/VECP(mLSG15) and KW-0761
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
19 sitesJapan
Study dates
Jul 2010to Apr 2012
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

Japan19 sites

  • Fukuoka University Hospital

    Fukuoka

  • Kyushu University Hospital

    Fukuoka

  • National Kyushu Cancer Center

    Fukuoka

  • Imamura Bun-in Hospital

    Kagoshima

  • Kagoshima University Hospital

    Kagoshima

  • Kokura Memorial Hospital

    Kitakyushu

  • Kumamoto University Hospital

    Kumamoto

  • National Hospital Organization Kumamoto Medical Center

    Kumamoto

  • NTT West Japan Kyushu Hospital

    Kumamoto

  • Nagasaki University Hospital

    Nagasaki

  • The Japanese Red Cross Nagasaki Genbaku Hospital

    Nagasaki

  • Aichi Cancer Center Hospital

    Nagoya

  • Nagoya City University Hospital

    Nagoya

  • Oita Prefectural Hospital

    Ōita

  • Heartlife Hospital

    Okinawa

  • National Hospital Organization Nagasaki Medical Center

    Ōmura

  • Sasebo City General Hospital

    Sasebo

  • National Cancer Center Hospital

    Tokyo

  • Ehime University Hospital

    Tōon

Other trials in Japan

About this study

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)

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.

Being tested
VCAP/AMP/VECP(mLSG15), KW-0761
Medical subject headings
Leukemia-Lymphoma, Adult T-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VCAP/AMP/VECP(mLSG15)Drug

    VCAP(Vincristine Sulfate, Cyclophosphamide Hydrate, Doxorubicin Hydrochloride, Prednisolone); AMP(Doxorubicin Hydrochloride, Ranimustine, Prednisolone); VECP(Vindesine Sulfate, Etoposide, Carboplatin, Prednisolone)

  • KW-0761Biological

    VCAP/AMP/VECP(mLSG15) + KW-0761

Study groups in NCT01173887
Study groupRoleWhat they receive
mLSG15Active comparatorNot described
Receives: Drug: VCAP/AMP/VECP(mLSG15)
mLSG15 + KW-0761ExperimentalNot described
Receives: Biological: KW-0761

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: After cycle 2 and cycle 4

Secondary outcomes (5)

  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

    Measured: After cycle 2 and cycle 4.

  2. Progression-free survival and Overall survival

    Measured: 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

    Measured: During the study period

  4. anti-KW-0761 antibody

    Measured: 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

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2010 (estimated)
  2. Study startJul 2010
  3. Primary completionApr 2012
  4. Study completionApr 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01173887
Sponsor's protocol ID
0761-003
Status last verified
Mar 2017
First submitted
30 Jul 2010
Last updated
30 Mar 2017
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing VCAP/AMP/VECP(mLSG15) and KW-0761 in people with Adult T-cell Leukemia-Lymphoma, run by Kyowa Kirin Co., Ltd. at 19 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete response rate in the best overall response assessment for antitumor effect (time frame: After cycle 2 and cycle 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01173887, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2017.

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