Golidocitinib With Azacitidine and Chidamide in Patients With Peripheral T-cell Lymphoma.
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRuijin Hospital
About this trial
In decades, the outcome of patients with peripherial T-cell lymphomas is dismal, especially in relapsed or refractory population. After failure to the frontline treatment, patients have limited treatment options and elderly population usually have no chance to undergo transplantation due to age or comorbidity, etc. Golidocitinib and chidamide were approved in treating r/r PTCL in China, while azacytidine has been demonstrated its anti-tumor activity in PTCL as well.
This study aims to explore the efficacy and safety of golidocitinib combined with azacytidine and chidamide in the patients with peripheral T-cell lymphoma who are eligible for intensive chemotherapy or transplantation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histopathologically confirmed peripheral T-cell lymphoma;
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2;
Expected survival of ≥12 weeks;
Measurable disease lesions;
Disqualifiers
Involvement of the central nervous system (CNS);
History of malignancies except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix;
Uncontrolled cardio- and cerebro-vascular disease, blood clotting disorders, connective tissue diseases, serious infectious diseases and other diseases
Left ventricular ejection fraction<50%
Trial design
Design model
Single group
Treatments tested in this trial
golidocitinib with azacytidine and chidamide
DrugIn Phase I, a "3+3" dose-escalation design will be adopted to enroll 3 to 12 participants, exploring the recommended Phase II dose (RP2D) at two dose levels of golidocitinib: 150 mg every other day (QOD) and 150 mg once daily (QD). In Phase II, we aim to evaluate the efficacy and safety of golidocitinib RP2D po in combination with chidamide 20mg biw po and azacytidine 100mg d1-7, SC in patients with peripheral T-cell lymphoma
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: golidocitinib with azacytidine and chidamideExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Overall Response Rate
Percentage of participants with complete response or partial response was determined on the basis of investigator assessments according to 2014 Lugano criteria
Time frame
Tumor evaluation was assessed at screening and at the end of treatment (around 3 cycles) then every 12-24 weeks until disease progression (each cycle is 21 days) through study completion, an average of 1 yearSecondary outcomes
1
Progression-free survival
Progression-free survival was defined as the time from the date of enrollment 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
Baseline up to data cut-off(up to approximately 3 years)2
Complete Response Rate
Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
Time frame
Tumor evaluation was assessed at screening and at the end of treatment (around 3 cycles) then every 12-24 weeks until disease progression (each cycle is 21 days) through study completion, an average of 1 year.3
Duration of Response
Applicable to complete or partial response participants. DoR was defined as the time from the first documented date of complete or partial response until the date of the disease progression or death from any causes.
Time frame
Baseline up to data cut-off(up to approximately 3 years)4
Overall survival
Overall survival was defined as the time from the date of enrollment to the date of death from any cause.
Time frame
Baseline up to data cut-off(up to approximately 3 years)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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