This is a multicenter prospective single arm phase II study. The purpose of this study is to evaluate the safety and efficiency of azacytidine combined with CAOLD Regimen in the treatment of relapsed/refractory peripheral t-cell lymphomas.
The investigators will evaluate response rate, progression free survival (PFS), overall survival (OS), and toxicity of azacytidine combined with CAOLD Regimen in relapsed/refractory peripheral t-cell lymphomas.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
52
Patients were treated by Azacytidine(75 mg/m2 on days 1-7) plus CAOLD regimen (cyclophosphamide 400mg/m2 qd d1; cytarabine 30mg/m2 qd d1-d4; vindesine 2mg/m2 qd d1; pegaspargase 2500iu/m2 qd d2; dexamethasone 7.5mg/m2 qd d1-d5)
Navy General Hospital
Beijing, Beijing Municipality, China
RECRUITINGOverall Response Rate (ORR)
ORR was defined as the proportion of patients who achieved CR or PR as their best response
Time frame: 1 year
Overall Survival (OS)
OS was defined as time from diagnosis to death from any cause or the last follow-up
Time frame: through study completion, an average of 2 year
Progression Free Survival (PFS)
PFS using local assessment of progressive disease according to Lugano Response Criteria (2014)
Time frame: 18 months
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