Chidamide and Duvalisibon for the Treatment of Refractory/Relapsed Peripheral T-cell Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe First Affiliated Hospital of Xiamen University
About this trial
To determine the efficacy and safety of Chidamide combined with Duvalisib in the treatment of refractory/relapsed peripheral T-cell lymphoma.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Peripheral T-cell lymphoma (PTCL) or NK/T-cell lymphoma confirmed by histopathology/cytology according to the classification standard of the World Health Organization in 2008
Relapsed and refractory patients who have received at least first-line systemic treatment with anthracycline-containing drugs in the past. Recurrence is defined as relapse after CR or progression after PR, SD. The refractory disease was defined as previous systemic chemotherapy, PD in response evaluation for 2 cycles or SD in response evaluation for 4 cycles.
There must be at least one evaluable or measurable lesion meeting Lugano2014 standard: lymph node lesion and the measurable lymph node length should be > 1.5cm;
Patients aged at 18-75 years old;
Disqualifiers
Patients with central nervous system (CNS) or meningeal invasion
Any of the following laboratory abnormalities: absolute neutrophil count (ANC) < 1.5× 10*9/L, Hb< 80 g/L, PLT < 75×10 9 /L, organ dysfunction, are defined as follows: total bilirubin (TBiL) > 1.5 upper limit of normal value (ULN), or AST or ALT >2.5ULN, except the following situations. if patients with liver infiltrated by lymphoma cells, AST and ALT < 5ULN could be enrolled.
International normalized ratio (INR)>1.5ULN or partially activated prothrombin time (APTT) > 1.5 ULN
The active infection of human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) should be excluded except for the following patients: patients with HBV infection (HBsAg or HBcAg positive) but HBV DNA negative. These patients need continuous antiviral treatment and HBV DNA PCR detection every cycle. additionally, patients with HCV serology positive but HCV RNA negative can be enrolled.
Trial design
Design model
Single group
Treatments tested in this trial
Chidamide combined with Duvillisib
DrugSpecified dose on specified days
Treatment groups
33 Participants
are divided into 1 treatment groupGroup A: Chidamide combined with DuvillisibExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Overall Response Rate
Percentage of participants with best overall response of partial response (PR) and complete response (CR), using the Lugano criteria.
Time frame
Up to 27 months2
Complete Response Rate
Complete response (CR) is evaluated according to the Lugano criteria for lymphoma response.
Time frame
Up to 27 monthsSecondary outcomes
1
Partial Response Rate
Partial response (PR) is evaluated according to the Lugano criteria for lymphoma response.
Time frame
Up to 27 months2
Progression Free Survival
Progression-free survival was defined as the time from the date of diagnosis until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first.
Time frame
Up to 27 months3
Overall Survival
OS will be measured from the date of registration to the date of the event (i.e., death) or the date of last follow-up to evaluate that event. Patients who are event-free at their last follow-up evaluation will be censored at that time point.
Time frame
Up to 27 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
The First Affiliated Hospital of Xiamen University
Lead sponsor
Fujian Cancer Hospital
Collaborator
Zhangzhou Affiliated Hospital of Fujian Medical University
Collaborator
Dongguan People's Hospital
Collaborator
Huizhou Municipal Central Hospital
Collaborator
The First Affiliated Hospital with Nanjing Medical University
Collaborator
Sun Yat-sen University
Collaborator
Shanxi Province Cancer Hospital
Collaborator
Source ClinicalTrials.gov