Clinical Trial: A Study of Treatment ALK(+) Systemic Anaplastic Large Cell Lymphoma With Crizotinib
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: A Multicenter Prospective Study of Treatment ALK(+) Systemic Anaplastic Large Cell Lymphoma With Crizotinib
Brief Summary: The purpose of this study is to determine the efficacy and safety of crizotinib combined with CHOP chemotherapy for patients with ALK(+) Systemic Anaplastic Large Cell Lymphoma.
Detailed Summary: ALK(+) Systemic Anaplastic Large Cell Lymphoma patients are treated with crizotinib when they receive CHOP chemotherapy. crizotinib 250mg twice a day is administrated from day 1 of chemotherapy to 18 weeks. standard CHOP chemotherapy (cyclophosphamide, 750mg per square meter of body-surface area,d1, vincristine, 1.4mg per square meter of body-surface area, maximal dose is 2mg d1, doxorubicin, 50mg per square meter of body-surface area d1, plus prednison, 100 mg d1-5) every 3 weeks for up to six cycles.
Sponsor: Jun Zhu
Current Primary Outcome: complete remission rate [ Time Frame: 2 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- disease-free survival [ Time Frame: 2 years ]
- overall survival [ Time Frame: 2 years ]
- objective response rate [ Time Frame: 2 years ]
- incidence of >/Grade 3 non-hematology toxicity adverse events [ Time Frame: 2 years ]
- QOL assessment [ Time Frame: 2 years ]using a battery of cognitive and quality-of-life (QoL) measures
Original Secondary Outcome: Same as current
Information By: Peking University
Dates:
Date Received: June 30, 2015
Date Started: July 2015
Date Completion: December 2017
Last Updated: December 28, 2016
Last Verified: December 2016