Conditions: Adult T-cell Leukemia-Lymphoma
Keywords: Adult T cell Leukemia-Lymphoma (ATL)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 71
Healthy volunteers: no

Brief summary:
The purpose of this study is to estimate the overall response rate of subjects with relapsed or refractory Adult T-cell Leukemia-Lymphoma (ATL).

Detailed description:
CCR4 expression in ATL patients has been demonstrated to be very high and has been associated with shorter survival compared with CCR4-negative patients. KW-0761, a monoclonal antibody targeted to CCR4, has been shown to be safe and tolerable in several clinical trials in subjects with a variety of T-cell malignancies, including ATL, mycosis fungoides and Sézary syndrome. The objective of this study is to estimate the overall response rate of KW-0761 for subjects with relapsed or refractory ATL.

Arms:
arm 1: anti-CCR4 monoclonal antibody KW-0761 (mogamulizumab) arm 2: Comparator is investigator's choice of pralatrexate or gemcitabine plus oxaliplatin or DHAP

Interventions: intervention 1: KW-0761 intervention 2: Pralatrexate intervention 3: gemcitabine plus oxaliplatin intervention 4: DHAP
Intervention descriptions: intervention 1: 1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression intervention 2: 30 mg/m2 weekly for 3 weeks followed by 1 week of no therapy until progression intervention 3: gemcitabine 1000 mg/m2, followed by oxaliplatin 100 mg/m2 every 2 weeks until progression intervention 4: dexamethasone 40 mg on Day 1-4, cisplatin 100 mg/m2 on Day 1 followed by 2 doses of cytarabine 2000 mg/m2 every 4 weeks until progression

Protocol document: