Peripheral T-Cell LymphomaPhase 2NCT01611142
Study of KW-0761 (Mogamulizumab) in Subjects With Previously Treated Peripheral T-cell Lymphoma (PTCL)
A Phase 2 study testing KW-0761 (mogamulizumab) in people with Peripheral T-Cell Lymphoma, run by Kyowa Kirin Co., Ltd. at 15 sites in 6 countries.
Trial summary
The primary objective of this study is to determine the overall response rate of KW-0761 for the treatment of patients with relapsed or refractory PTCL. KW-0761 targets CCR4. CCR4 is the receptor for macrophage derived chemokines MDC/CCL22 and TARC/CCL17. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral T-Cell Lymphoma
- What is being tested?
- KW-0761 (mogamulizumab)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 15 sitesin 6 countries
- Study dates
- Apr 2012to May 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years of age at the time of enrollment;
- Histologically confirmed diagnosis of PTCL as specified below:
- PTCL-NOS
- Angioimmunoblastic T-cell lymphoma
- Anaplastic large cell lymphoma, ALK-positive
- Anaplastic large cell lymphoma, ALK-negative
Show all 13Show fewer
- Transformed mycosis fungoides
- Failed or intolerant of at least one prior systemic anticancer therapy;
- ECOG performance status score of ≤ 2 at study entry;
- At least one site of disease measurable in two dimensions by computed tomography (CT);
- Subjects who are positive for CCR4 by immunohistochemistry;
- Resolution of all clinically significant toxic effects of prior cancer therapy to grade ≤1 (NCI-CTCAE, v.4.0);
- Adequate hematological hepatic and renal function.
Who cannot join
- Subject with the following PTCL diagnoses are excluded;
- Precursor T/NK neoplasms
- Adult T-cell leukemia-lymphoma
- T-cell prolymphocytic leukemia
- T-cell large granular lymphocytic leukemia
- Aggressive NK-cell leukemia
Show all 36Show fewer
- Systemic EBV-positive T-cell lymphoproliferative disorder of childhood
- Hydroa vacciniforme-like lymphoma
- Mycosis fungoides, other than transformed mycosis fungoides
- Sezary Syndrome
- Primary cutaneous CD30+ disorders: Anaplastic large cell lymphoma and lymphatoid papulosis
- Primary cutaneous CD8+ aggressive epidermotropic cytoxic T-cell lymphoma
- Primary cutaneous CD4+ small/medium T-cell lymphoma
- Primary cutaneous gamma-delta T-cell lymphoma
- Extranodal NK/T T-cell lymphoma-nasal type
- Enteropathy-associated T-cell lymphoma
- Hepatosplenic T-cell lymphoma
- Subcutaneous panniculitis -like T-cell lymphoma
- Chronic lymphoproliferative disorder of NK cells
- Have had an invasive solid tumor malignancy in the past five years except non-melanoma skin cancers, melanoma in situ, cervical carcinoma in situ, ductal/lobular carcinoma in situ of the breast, or localized prostate cancer with a current PSA of ≤ 0.1 ng/ml who is currently without evidence of disease;
- Relapsed less than 75 days of autologous stem cell transplant;
- History of allogeneic stem cell transplant;
- Evidence of central nervous system (CNS) metastasis;
- Psychiatric illness, disability or social situation that would compromise the subject's safety or ability to provide consent, or limit compliance with study requirements;
- Subjects with a history of moderate or severe psoriasis or with psoriasis associated with systemic symptoms e.g. arthropathy), or with a 1st degree relative with history of psoriasis that required medical intervention;
- Significant uncontrolled intercurrent illness;
- Known or tests positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C;
- Active herpes simplex or herpes zoster;
- Experienced allergic reactions to monoclonal antibodies or other therapeutic proteins;
- Known active autoimmune disease will be excluded (For example: Grave's disease; systemic lupus erythematosus; rheumatoid arthritis; Crohn's disease);
- Is pregnant (confirmed by beta human chorionic gonadotrophin [β-HCG]) or lactating; Prohibited Therapies and/or Medications
- Prior treatment with KW-0761;
- Initiation of treatment with systemic steroids while on study is only permitted for acute and brief complications of underlying disease (e.g., hypercalcemia) or for treatment related side effects;
- Initiation of treatment with topical steroids while on study is not permitted except to treat an acute rash;
- Have had anti-neoplastic chemotherapy, radiation, immunotherapy, or investigational medications within 4 weeks of screening visit;
- Subjects on any immunomodulatory drug.
Trial locations and contacts
15 sites in 6 countries.
15 sites in 6 countries
France5 sites
CHU Henri Mondor
Créteil, 94010
CHRU Lille
Lille, 59037
Hopital Saint-Louis
Paris, 75010
Centre Hospitaliser de Lyon Sud
Pierre-Bénite, 69310
Centre Henri Becquerel
Rouen, 76038
Spain3 sites
Institut Catalá D'Oncologia, Hospital Duran y Reynals
Barcelona, 08908
Hospital Univesitario 12 de Octubre
Madrid, 28041
Hospital Clínico Universitario de Salamanca
Salamanca, 37191
United Kingdom3 sites
Guy's Hospital
London, SE1 9RT
Christie Hospital
Manchester, M20 4BX
Cancer Research UK Centre/Southhampton General Hospital
SouthHampton, SO16 6YD
Netherlands2 sites
Vrije Universiteit Medisch Centrum (VUMC)
Amsterdam, 1081 HV
Universitair Medisch Centrum Groningen (UMCG)
Groningen, 9713 GZ
About this study
Official title: Open-Label, Multi-Center, Phase 2 Study of Anti-CCR4 Monoclonal Antibody KW-0761 (Mogamulizumab) in Subjects With Previously Treated Peripheral T-cell Lymphoma (PTCL)
The primary objective of this study is to determine the overall response rate of KW-0761 for the treatment of patients with relapsed or refractory PTCL. KW-0761 targets CCR4. CCR4 is the receptor for macrophage derived chemokines MDC/CCL22 and TARC/CCL17. Chemokines are considered to play a role both in the recruitment of immune and inflammatory cells for anti-tumor response and in the selective homing of neoplastic B and T cells.
Read the detailed description
PTCL is a rare and heterogeneous disease that remains difficult to diagnose and treat. In the majority of PTCL subtypes, patients are of older age (>60 years) and present with advanced stage disease.With the exception of the ALCL-ALK-positive subtype that responds well to CHOP combined chemotherapy, most PTCL subtypes become refractory even to aggressive chemotherapy regimens or relapse. Overall survival of PTCL patients is poor compared with that of aggressive B-cell lymphomas.Thus, novel and effective therapies are needed.KW-0761(mogamulizumab) is a defucosylated, humanized, IgG1 mAb with enhanced antibody dependent cellular cytotoxicity (ADCC)that binds to CCR4, a molecule that is suggested to be significantly involved in patients with PTCL.
- Conditions
- Peripheral T-Cell Lymphoma
- Being tested
- KW-0761 (mogamulizumab)
- Keywords
- Monoclonal antibody, Peripheral T-cell Lymphoma, cancer, hematologic malignancy
- Medical subject headings
- Lymphoma, T-Cell, Peripheral, Neoplasms, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KW-0761 (mogamulizumab)Biological
Also called mogamulizumab, POTELIGEO®
1 mg/kg administered intravenously weekly x 4 then every other week until progression
| Study group | Role | What they receive |
|---|---|---|
| KW-0761 | Experimental | Not described Receives: Biological: KW-0761 (mogamulizumab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate
Measured: every 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2012 (estimated)
- Study startApr 2012
- Primary completionMay 2015
- Study completionMay 2015
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-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
- Masking
- None (open label)
- Enrolment
- 38 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
- Pier Luigi Zinzani, M.D., PhD, Principal investigator, Universita di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01611142
- Sponsor's protocol ID
- PROTOCOL 0761-007
- Status last verified
- Jun 2024
- First submitted
- 30 May 2012
- Last updated
- 17 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Zinzani PL, Karlin L, Radford J, Caballero D, Fields P, Chamuleau ME, d'Amore F, Haioun C, Thieblemont C, Gonzalez-Barca E, Garcia CG, Johnson PW, van Imhoff GW, Ng T, Dwyer K, Morschhauser F. European phase II study of mogamulizumab, an anti-CCR4 monoclonal antibody, in relapsed/refractory peripheral T-cell lymphoma. Haematologica. 2016 Oct;101(10):e407-e410. doi: 10.3324/haematol.2016.146977. Epub 2016 Jul 14. No abstract available.
PubMed 27418646
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Multi-Center, Phase 2 Study of Anti-CCR4 Monoclonal Antibody KW-0761 (Mogamulizumab) in Subjects With Previously Treated Peripheral T-cell Lymphoma (PTCL)
- ClinicalTrials.gov ID
- NCT01611142
- Acronym / sponsor ID
- PROTOCOL 0761-007
- Conditions
- Peripheral T-Cell Lymphoma
- Keywords
- Monoclonal antibody, Peripheral T-cell Lymphoma, cancer, hematologic malignancy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Kyowa Hakko Kirin Pharma, Inc.
- Study start
- Apr 2012
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 4 Jun 2012 (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 primary objective of this study is to determine the overall response rate of KW-0761 for the treatment of patients with relapsed or refractory PTCL. KW-0761 targets CCR4. CCR4 is the receptor for macrophage derived chemokines MDC/CCL22 and TARC/CCL17. Chemokines are considered to play a role both in the recruitment of immune and inflammatory cells for anti-tumor response and in the selective homing of neoplastic B and T cells.
Detailed description
PTCL is a rare and heterogeneous disease that remains difficult to diagnose and treat. In the majority of PTCL subtypes, patients are of older age (>60 years) and present with advanced stage disease.With the exception of the ALCL-ALK-positive subtype that responds well to CHOP combined chemotherapy, most PTCL subtypes become refractory even to aggressive chemotherapy regimens or relapse. Overall survival of PTCL patients is poor compared with that of aggressive B-cell lymphomas.Thus, novel and effective therapies are needed.KW-0761(mogamulizumab) is a defucosylated, humanized, IgG1 mAb with enhanced antibody dependent cellular cytotoxicity (ADCC)that binds to CCR4, a molecule that is suggested to be significantly involved in patients with PTCL.
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 (mogamulizumab) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- ≥18 years of age at the time of enrollment;
- Histologically confirmed diagnosis of PTCL as specified below:
- Failed or intolerant of at least one prior systemic anticancer therapy;
- ECOG performance status score of ≤ 2 at study entry;
- At least one site of disease measurable in two dimensions by computed tomography (CT);
Key exclusion criteria (36 listed)
- Subject with the following PTCL diagnoses are excluded;
- Have had an invasive solid tumor malignancy in the past five years except non-melanoma skin cancers, melanoma in situ, cervical carcinoma in situ, ductal/lobular carcinoma in situ of the breast, or localized prostate cancer with a current PSA of ≤ 0.1 ng/ml who is currently without evidence of disease;
- Relapsed less than 75 days of autologous stem cell transplant;
- History of allogeneic stem cell transplant;
- Evidence of central nervous system (CNS) metastasis;
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-0761 (mogamulizumab)Also: mogamulizumab, POTELIGEO®1 mg/kg administered intravenously weekly x 4 then every other week until progression | Biological | KW-0761 |
Primary outcome
Overall Response Rate
Time frame: every 8 weeks
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 17 Jun 2024.
- Derived from this study: PubMed 27418646Zinzani PL, Karlin L, Radford J, Caballero D, Fields P, Chamuleau ME, d'Amore F, Haioun C, Thieblemont C, Gonzalez-Barca E, Garcia CG, Johnson PW, van Imhoff GW, Ng T, Dwyer K, Morschhauser F. European phase II study of mogamulizumab, an anti-CCR4 monoclonal antibody, in relapsed/refractory peripheral T-cell lymphoma. Haematologica. 2016 Oct;101(10):e407-e410. doi: 10.3324/haematol.2016.146977. Epub 2016 Jul 14. No abstract available.
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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.
Pier Luigi Zinzani, M.D., PhD principal investigator
Universita di Bologna
15 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KW-0761 (mogamulizumab) in people with Peripheral T-Cell Lymphoma, run by Kyowa Kirin Co., Ltd. at 15 sites in 6 countries.
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 13 inclusion and 36 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 17 Jun 2024. 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 France, Spain, United Kingdom, Netherlands, Denmark and 1 more country. 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?
Overall Response Rate (time frame: every 8 weeks). 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 NCT01611142, 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 17 Jun 2024.