Peripheral T/NK-cell LymphomaPhase 2NCT01192984
Study of KW-0761 in Subjects With CCR4-positive Peripheral T/NK-cell Lymphoma
A Phase 2 study testing KW-0761 in people with Peripheral T/NK-cell Lymphoma, run by Kyowa Kirin Co., Ltd. at 15 sites in Japan.
Trial summary
The purpose of this study is to evaluate the efficacy of KW-0761 intravenously administered eight times at one-week intervals in patients with CCR4-positive peripheral T/NK-cell lymphoma. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Peripheral T/NK-cell Lymphoma
- What is being tested?
- KW-0761
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 15 sitesJapan
- Study dates
- Sep 2010to May 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 with hematologically or pathohistologically diagnosed peripheral T/NK-cell lymphoma
- Subjects who have been positive for CCR4
- Subjects who received one or more chemotherapy regimens
- Subjects who relapse after achieving complete response, uncertain complete response or partial response by the last chemotherapy
- Subjects who have an interval of 4 weeks or more between the last day of the prior therapy and the scheduled day of the first KW-0761 treatment
- Subjects with nodal lesions, extranodal lesions and/or cutaneous lesions
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- Subjects who have a performance status of 0 to 2
- Subjects who are negative for HBs antigen and reported as "not detected" for HBV-DNA
- Subjects who are negative for anti-HCV antibody
- Subjects who have normal function of the major organs
- Subjects who have given written voluntary informed consent to participate in the study
Who cannot join
- Subjects who underwent transplant therapy such as hematopoietic stem-cell transplantation (Subjects who underwent autologous hematopoietic stem-cell transplantation following chemotherapy will not be excluded)
- Subjects who are known carriers of HIV
- Subjects who have active multiple cancer
- Subjects who have a history of allergic reactions to therapeutic antibodies
- Subjects requiring continuous systemic treatment with steroid
- Subjects who require emergency radiotherapy for treating the symptoms caused by bulky masses at enrollment 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
15 sites in 1 country.
15 sites in 1 country
Japan15 sites
Kyushu University Hospital
Fukuoka
National Kyushu Cancer Center
Fukuoka
Tokai University Hospital
Isehara
Imamura Bun-in Hospital
Kagoshima
University Hospital, Kyoto Prefectural University of Medicine
Kyoto
Nagasaki University Hospital
Nagasaki
Aichi Cancer Center Hospital
Nagoya
Nagoya City University Hospital
Nagoya
Nagoya Daini Red Cross Hospital,
Nagoya
Okayama University Hospital
Okayama
Hokkaido University Hospital
Sapporo
Tohoku University Hospital
Sendai
Cancer Institute Hospital
Tokyo
National Cancer Center Hospital
Tokyo
Mie University Hospital
Tsu
About this study
Official title: Phase II Study of KW-0761 in Subjects With CCR4-positive Peripheral T/NK-cell Lymphoma
The purpose of this study is to evaluate the efficacy of KW-0761 intravenously administered eight times at one-week intervals in patients with CCR4-positive peripheral T/NK-cell lymphoma. The primary objective is to assess the antitumor effect in terms of best overall response, while the secondary objectives are to assess the antitumor effect in terms of best response by disease lesion, to assess the progression-free survival and to assess the overall survival. The safety and pharmacokinetic profiles of KW-0761 will be also evaluated.
- Conditions
- Peripheral T/NK-cell Lymphoma
- Being tested
- KW-0761
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KW-0761Biological
Intravenously 8 times at 1-week intervals
| Study group | Role | What they receive |
|---|---|---|
| KW-0761 | Experimental | Not described Receives: Biological: KW-0761 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antitumor effect (best overall response)
Secondary outcomes (3)
Antitumor effect (best response by disease lesion), progression-free survival and overall survival
Adverse events and anti-KW-0761 antibody levels
Plasma KW-0761 concentrations and pharmacokinetic parameters
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral T/NK-cell LymphomaStudies of the same condition, open and under way.
- More trials run by Kyowa Kirin Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01192984
- Sponsor's protocol ID
- 0761-004
- Status last verified
- Feb 2017
- First submitted
- 30 Aug 2010
- Last updated
- 3 Mar 2017
- Results posted
- No
Publications
Ogura M, Ishida T, Hatake K, Taniwaki M, Ando K, Tobinai K, Fujimoto K, Yamamoto K, Miyamoto T, Uike N, Tanimoto M, Tsukasaki K, Ishizawa K, Suzumiya J, Inagaki H, Tamura K, Akinaga S, Tomonaga M, Ueda R. Multicenter phase II study of mogamulizumab (KW-0761), a defucosylated anti-cc chemokine receptor 4 antibody, in patients with relapsed peripheral T-cell lymphoma and cutaneous T-cell lymphoma. J Clin Oncol. 2014 Apr 10;32(11):1157-63. doi: 10.1200/JCO.2013.52.0924. Epub 2014 Mar 10.
PubMed 24616310
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of KW-0761 in Subjects With CCR4-positive Peripheral T/NK-cell Lymphoma
- ClinicalTrials.gov ID
- NCT01192984
- Acronym / sponsor ID
- 0761-004
- Conditions
- Peripheral T/NK-cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 1 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy of KW-0761 intravenously administered eight times at one-week intervals in patients with CCR4-positive peripheral T/NK-cell lymphoma. The primary objective is to assess the antitumor effect in terms of best overall response, while the secondary objectives are to assess the antitumor effect in terms of best response by disease lesion, to assess the progression-free survival and to assess the overall survival. The safety and pharmacokinetic profiles of KW-0761 will be also evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KW-0761 | Experimental | Biological: KW-0761 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subjects with hematologically or pathohistologically diagnosed peripheral T/NK-cell lymphoma
- Subjects who have been positive for CCR4
- Subjects who received one or more chemotherapy regimens
- Subjects who relapse after achieving complete response, uncertain complete response or partial response by the last chemotherapy
- Subjects who have an interval of 4 weeks or more between the last day of the prior therapy and the scheduled day of the first KW-0761 treatment
Key exclusion criteria (7 listed)
- Subjects who underwent transplant therapy such as hematopoietic stem-cell transplantation (Subjects who underwent autologous hematopoietic stem-cell transplantation following chemotherapy will not be excluded)
- Subjects who are known carriers of HIV
- Subjects who have active multiple cancer
- Subjects who have a history of allergic reactions to therapeutic antibodies
- Subjects requiring continuous systemic treatment with steroid
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KW-0761Intravenously 8 times at 1-week intervals | Biological | KW-0761 |
Primary outcome
Antitumor effect (best overall response)
3 secondary outcomes
Antitumor effect (best response by disease lesion), progression-free survival and overall survival
Adverse events and anti-KW-0761 antibody levels
Plasma KW-0761 concentrations and pharmacokinetic parameters
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- Derived from this study: PubMed 24616310Ogura M, Ishida T, Hatake K, Taniwaki M, Ando K, Tobinai K, Fujimoto K, Yamamoto K, Miyamoto T, Uike N, Tanimoto M, Tsukasaki K, Ishizawa K, Suzumiya J, Inagaki H, Tamura K, Akinaga S, Tomonaga M, Ueda R. Multicenter phase II study of mogamulizumab (KW-0761), a defucosylated anti-cc chemokine receptor 4 antibody, in patients with relapsed peripheral T-cell lymphoma and cutaneous T-cell lymphoma. J Clin Oncol. 2014 Apr 10;32(11):1157-63. doi: 10.1200/JCO.2013.52.0924. Epub 2014 Mar 10.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KW-0761 in people with Peripheral T/NK-cell Lymphoma, run by Kyowa Kirin Co., Ltd. at 15 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 11 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 3 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 15 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?
Antitumor effect (best overall response). 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 NCT01192984, 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 3 Mar 2017.