Study of KW-0761 (Mogamulizumab) in Subjects With Previously Treated Peripheral T-cell Lymphoma (PTCL)

NCT01611142 | Completed Phase 2

• 1 other identifier: PROTOCOL 0761-007
• Study Type: interventional
• Target: 38
• Locations: 6 countries
• Sites: 15

Brief 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. 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.

Conditions

Peripheral T-Cell Lymphoma

Keywords

Monoclonal antibody; Peripheral T-cell Lymphoma; cancer; hematologic malignancy

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  every 8 weeks

Study Arms (1)

KW-0761

EXPERIMENTAL

Biological: KW-0761 (mogamulizumab)

Interventions

KW-0761 (mogamulizumab) BIOLOGICAL

1 mg/kg administered intravenously weekly x 4 then every other week until progression

Also known as: mogamulizumab, POTELIGEO®

KW-0761

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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
• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Kyowa Kirin Co., Ltd.: lead
• Kyowa Hakko Kirin Pharma, Inc.: collaborator

Study Sites (15)

Aarhus University Hospital

Aarhus, 8000, Denmark

Location

CHU Henri Mondor

Créteil, 94010, France

Location

CHRU Lille

Lille, 59037, France

Location

Hopital Saint-Louis

Paris, 75010, France

Location

Centre Hospitaliser de Lyon Sud

Pierre-Bénite, 69310, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

Università di Bologna

Bologna, Italy

Location

Vrije Universiteit Medisch Centrum (VUMC)

Amsterdam, 1081 HV, Netherlands

Location

Universitair Medisch Centrum Groningen (UMCG)

Groningen, 9713 GZ, Netherlands

Location

Institut Catalá D'Oncologia, Hospital Duran y Reynals

Barcelona, 08908, Spain

Location

Hospital Univesitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Clínico Universitario de Salamanca

Salamanca, 37191, Spain

Location

Guy's Hospital

London, SE1 9RT, United Kingdom

Location

Christie Hospital

Manchester, M20 4BX, United Kingdom

Location

Cancer Research UK Centre/Southhampton General Hospital

SouthHampton, SO16 6YD, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 27418646 DERIVED

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral; Neoplasms; Hematologic Neoplasms

Interventions

mogamulizumab

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms by Site; Hematologic Diseases

Study Officials

• Pier Luigi Zinzani, M.D., PhD

  Universita di Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2012
• First Posted: June 4, 2012
• Study Start: April 1, 2012
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: June 17, 2024

Record last verified: 2024-06

Locations

GB (3); DK (1); NL (2); IT (1); FR (5); ES (3)