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 chidamide in the treatment of relapsed/refractory angioimmunoblastic T-cell lymphoma.
Azacytidine was given subcutaneously at a dose of 75 mg/m2 on days 1-7. Chidamide was an oral tablet which was administered 20mg twice weekly. This regimen was repeated every 28 days. Treatment was given until disease progression, unacceptable toxicity, or patient/investigator discretion.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
75 mg/m2 subcutaneously on days 1-7
20mg orally per week continuously
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Overall Response Rate (ORR)
ORR was defined as the proportion of patients who achieved CR or PR as their best response
Time frame: 1year
progression-free survival (PFS)
PFS was defined as time from diagnosis to the date of disease progression or death from any cause or the last follow-up.
Time frame: 1 year
Duration of response (DOR)
DOR was defined as the time from the first occurrence of CR or PR to the first diagnosis of PD or relapse.
Time frame: through study completion, an average of 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
Adverse Events
Graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Time frame: During the whole treatment
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