A Phase 2 interventional study of Azacitidine and Chidamide in Angioimmunoblastic T-cell Lymphoma, sponsored by Peking Union Medical College Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-05.
Sponsored by Peking Union Medical College Hospital · Phase 2, Interventional, and Treatment
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.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's planned enrollment of 20 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients in the experimental arm will received azacytidine plus chidamide treatment. This regimen was repeated every 28 days.
Drug: Azacitidine · Drug: Chidamide
75 mg/m2 subcutaneously on days 1-7
20mg orally per week continuously
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
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Peking Union Medical College Hospital