A Phase 4 interventional study of crizotinib in Systemic Anaplastic Large-Cell Lymphoma, sponsored by Jun Zhu. Withdrawn at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-12-30.
Sponsored by Jun Zhu · Phase 4, Interventional, and Treatment
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.
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.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
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Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
crizotinib 250mg, bid from day 1 to 18 weeks. cyclophosphamide, 750mg/m2,d1, vincristine, 1.4mg/m2, maximal dose is 2mg d1, doxorubicin, 50mg/m2d1, prednison, 100 mg d1-5) every 3 weeks for up to six cycles.
Drug: crizotinib
crizotinib 250mg, oral, bid from day 1 to 18 weeks. cyclophosphamide, 750mg/m2,d1, vincristine, 1.4mg/m2, maximal dose is 2mg d1, doxorubicin, 50mg/m2d1, prednison, 100 mg d1-5) every 3 weeks for up to six cycles.
Also known as: CHOP chemotherapy
complete remission rate
Time frame: 2 years
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
using a battery of cognitive and quality-of-life (QoL) measures
Time frame: 2 years
This study is withdrawn, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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Jun Zhu