At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Multi-Center, Open-Label, Randomized Study of Anti-CCR4 Monoclonal Antibody KW-0761 or Investigator's Choice in Subjects With Previously Treated Adult T-cell Leukemia-Lymphoma (ATL)
In Brief
A Phase 2 clinical trial evaluating KW-0761, Pralatrexate, and 2 other interventions for Adult T-cell Leukemia-Lymphoma. Completed, enrolled 71 participants across 20 sites in 6 countries.
Detailed 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).
Study Details
Timeline
Interventions
1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression
30 mg/m2 weekly for 3 weeks followed by 1 week of no therapy until progression
gemcitabine 1000 mg/m2, followed by oxaliplatin 100 mg/m2 every 2 weeks until progression
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