A Phase 2 interventional study of Chidamide in Angioimmunoblastic T-cell Lymphoma, sponsored by Qingdao University. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-09-25.
Sponsored by Qingdao University · Phase 2, Interventional, and Treatment
This study aims to investigate the efficacy and safety of PET regimen combined with Chidamide for angioimmunoblastic T cell lymphoma patients.
Patients enrolled in the trial would be given prednisone, etoposide, thalidomide and Chidamide, and the response and side effects are observed and documented.
Exclusion Criteria:
In this group, patients will be given prednisone 100mg,qd,d1-5; etoposide 100mg,qd,d1-5; thalidomide 100mg,qn,d1-14; Chidamide 30mg,biw;
Drug: Chidamide
Chidamide will be given orally 30mg,biw, along with PET regimen (prednisone 100mg,po,qd,d1-5; etoposide 100mg,po,qd,d1-5; thalidomide 100mg,po,qn,d1-14;)
Also known as: PCT regimen
Objective remission rate(ORR)
the rate of patients who achieve objective remission after the treatment,including CR (complete remission),CRu (complete remission with unrecovered platelet count) and PR (partial remission).
Time frame: every 3 months until 24 months after the last patient's enrollment
duration of remission
from date of complete remission to date of progression, relapse, or death from any cause
Time frame: from the day of remission to the date of first documented progression,up to 24 months after the last patient's enrollment
progression free survival
from date of inclusion to date of progression, relapse, or death from any cause
Time frame: from the day of treatment to the date of first documented progression,up to 24 months after the last patient's enrollment
overall survival
from the date of inclusion to date of death, irrespective of cause
Time frame: 24 months after the last patient's enrollment
Plan to share: Yes — After the trial is finished, all the data would be available at the principle investigator's location.
Supporting information: Study protocol, Sap, Icf
This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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Qingdao University