Peripheral T-cell LymphomaPhase 2NCT01226472
Extension Study in Subjects Who Relapsed After Complete Response on Study KW-0761-001
A Phase 2 study testing KW-0761 in people with Peripheral T-cell Lymphoma and Cutaneous T-cell Lymphoma, run by Kyowa Kirin Co., Ltd. at 1 site in United States.
Trial summary
This study will enroll subjects with either Peripheral T-Cell Lymphoma (PTCL) or Cutaneous T-Cell Lymphoma(CTCL),including mycosis fungoides (MF) and Sezary Syndrome (SS), who have relapsed after achieving a complete response in study, KW-0761-001. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral T-cell Lymphoma, Cutaneous T-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
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Sep 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. The subject has relapsed after achieving a complete response to treatment with KW 0761 for PTCL or CTCL on study, KW-0761-001.
- 2. The subject has an Eastern Cooperative Oncology Group (ECOG) performance status score of < 2 at study entry.
- 3. The subject is >18 years of age. 4. The subject has adequate hematological function: absolute neutrophil count [ANC] >1,500 cells/uL and platelets >100,000 cells/uL,except in patients with known bone marrow involvement where absolute neutrophil count [ANC] must be > 1,000 cells/uL and platelets >75,000 cells/uL.
- 5. The subject has adequate hepatic function: bilirubin ≤ 1.5 times the specific institutional upper limit of normal [ULN]; aspartate transaminase [AST] and alanine transaminase [ALT] each ≤ 2.5 x ULN or ≤ 5.0 x ULN in the presence of known hepatic malignancy.
- 6. The subject has serum creatinine ≤1.5 x ULN or a calculated creatinine clearance >60 mL/min.
- 7. Subjects with MF and a history of staphylococcus colonization are eligible provided they continue to receive stable doses of prophylactic antibiotics.
Who cannot join
- The subject has received any type of treatment for their disease since completing study, KW-0761-001.
- The subject has a significant uncontrolled intercurrent illness including, but not limited to: uncontrolled infection requiring antibiotics; clinically significant cardiac disease (class III or IV of the New York Heart Association [NYHA] classification); unstable angina pectoris; angioplasty, stenting, or myocardial infarction within 6 months; uncontrolled hypertension (systolic blood pressure >160 mmHg, diastolic BP >100 mmHg, found on two consecutive measurements separated by a 1 week period) despite two anti-hypertensive medications; clinically significant cardiac arrhythmia; or uncontrolled diabetes.
- Subjects on any immunomodulatory drug, (other than low dose corticosteroids equivalent to a daily dose of 10 mg of prednisone
- The subject has a psychiatric illness, disability or social situation that would compromise the subject's safety or ability to provide consent, or limit his or her compliance with study requirements.
- The subject has experienced allergic reactions to monoclonal antibodies or other therapeutic proteins.
- Subjects with active herpes simplex or herpes zoster.
- Subjects with known autoimmune diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-Label Extension Study of Anti-CCR4 Monoclonal Antibody KW-0761 as Monotherapy in Subjects Who Relapsed After Complete Response on Study KW-0761-001
This study will enroll subjects with either Peripheral T-Cell Lymphoma (PTCL) or Cutaneous T-Cell Lymphoma(CTCL),including mycosis fungoides (MF) and Sezary Syndrome (SS), who have relapsed after achieving a complete response in study, KW-0761-001.
- Being tested
- KW-0761
- Keywords
- PTCL, CTCL, MF, SS
- Medical subject headings
- Lymphoma, T-Cell, Peripheral, Lymphoma, T-Cell, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KW-0761Biological
In the first treatment course KW-0761 will be administered i.v. once a week for four weeks, followed by a 2-week observation period. Subsequent treatment courses are permissible for subjects demonstrating a response or maintaining stable disease and will consist of an infusion of KW-0761 every other week.
| 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.
Global Composite Response (Skin, Blood, Lymph Nodes)as Determined by Skin Evaluations, Blood Counts and PET/CT Imaging
Measured: one year
Secondary outcomes (1)
Number of Participants With Adverse Events as a Measure of Safety and Tolerability.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2010 (estimated)
- Study startAug 2010
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peripheral T-cell LymphomaStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kyowa Hakko Kirin Pharma, Inc.
- Responsible party
- Sponsor
- Investigators
- Michael Kurman, M.D., Study director, Kyowa Hakko Kirin Pharma, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01226472
- Sponsor's protocol ID
- KW-0761-002
- Status last verified
- Apr 2024
- First submitted
- 19 Oct 2010
- Last updated
- 25 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Extension Study of Anti-CCR4 Monoclonal Antibody KW-0761 as Monotherapy in Subjects Who Relapsed After Complete Response on Study KW-0761-001
- ClinicalTrials.gov ID
- NCT01226472
- Acronym / sponsor ID
- KW-0761-002
- Keywords
- PTCL, CTCL, MF, SS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Kyowa Hakko Kirin Pharma, Inc.
- Study start
- Aug 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 22 Oct 2010 (estimated)
- Results
- Posted 29 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will enroll subjects with either Peripheral T-Cell Lymphoma (PTCL) or Cutaneous T-Cell Lymphoma(CTCL),including mycosis fungoides (MF) and Sezary Syndrome (SS), who have relapsed after achieving a complete response in study, KW-0761-001.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KW-0761 | Experimental | Biological: KW-0761 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1. The subject has relapsed after achieving a complete response to treatment with KW 0761 for PTCL or CTCL on study, KW-0761-001.
- 2. The subject has an Eastern Cooperative Oncology Group (ECOG) performance status score of < 2 at study entry.
- 3. The subject is >18 years of age. 4. The subject has adequate hematological function: absolute neutrophil count [ANC] >1,500 cells/uL and platelets >100,000 cells/uL,except in patients with known bone marrow involvement where absolute neutrophil count [ANC] must be > 1,000 cells/uL and platelets >75,000 cells/uL.
- 5. The subject has adequate hepatic function: bilirubin ≤ 1.5 times the specific institutional upper limit of normal [ULN]; aspartate transaminase [AST] and alanine transaminase [ALT] each ≤ 2.5 x ULN or ≤ 5.0 x ULN in the presence of known hepatic malignancy.
- 6. The subject has serum creatinine ≤1.5 x ULN or a calculated creatinine clearance >60 mL/min.
Key exclusion criteria (7 listed)
- The subject has received any type of treatment for their disease since completing study, KW-0761-001.
- The subject has a significant uncontrolled intercurrent illness including, but not limited to: uncontrolled infection requiring antibiotics; clinically significant cardiac disease (class III or IV of the New York Heart Association [NYHA] classification); unstable angina pectoris; angioplasty, stenting, or myocardial infarction within 6 months; uncontrolled hypertension (systolic blood pressure >160 mmHg, diastolic BP >100 mmHg, found on two consecutive measurements separated by a 1 week period) despite two anti-hypertensive medications; clinically significant cardiac arrhythmia; or uncontrolled diabetes.
- Subjects on any immunomodulatory drug, (other than low dose corticosteroids equivalent to a daily dose of 10 mg of prednisone
- The subject has a psychiatric illness, disability or social situation that would compromise the subject's safety or ability to provide consent, or limit his or her compliance with study requirements.
- The subject has experienced allergic reactions to monoclonal antibodies or other therapeutic proteins.
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-0761In the first treatment course KW-0761 will be administered i.v. once a week for four weeks, followed by a 2-week observation period. Subsequent treatment courses are permissible for subjects demonstrating a response or maintaining stable disease and will consist of an infusion of KW-0761 every other week. | Biological | KW-0761 |
Primary outcome
Global Composite Response (Skin, Blood, Lymph Nodes)as Determined by Skin Evaluations, Blood Counts and PET/CT Imaging
Time frame: one year
1 secondary outcome
Number of Participants With Adverse Events as a Measure of Safety and Tolerability.
Time frame: one year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Michael Kurman, M.D. study director
Kyowa Hakko Kirin Pharma, Inc.
1 site 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-cell Lymphoma and Cutaneous T-cell Lymphoma, run by Kyowa Kirin Co., Ltd. at 1 site in United States.
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 6 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 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Yes. Results are posted in the registry (first posted 29 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Global Composite Response (Skin, Blood, Lymph Nodes)as Determined by Skin Evaluations, Blood Counts and PET/CT Imaging (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Apr 2024.