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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
38
1 mg/kg administered intravenously weekly x 4 then every other week until progression
Aarhus University Hospital
Aarhus, Denmark
CHU Henri Mondor
Créteil, France
CHRU Lille
Lille, France
Overall Response Rate
Time frame: every 8 weeks
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Hopital Saint-Louis
Paris, France
Centre Hospitaliser de Lyon Sud
Pierre-Bénite, France
Centre Henri Becquerel
Rouen, France
Università di Bologna
Bologna, Italy
Vrije Universiteit Medisch Centrum (VUMC)
Amsterdam, Netherlands
Universitair Medisch Centrum Groningen (UMCG)
Groningen, Netherlands
Institut Catalá D'Oncologia, Hospital Duran y Reynals
Barcelona, Spain
...and 5 more locations