Sintilimab Combined With Chidamide in Treating Peripheral T Cell Lymphoma
ConditionPeripheral T-cell Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFudan University
About this trial
This is a single-center, single-arm, phase 2 study to evaluate the efficacy and safety of Anti-PD-1 antibody(Sintilimab) plus HDAC inhibitor(Chidamide) in patients with relapsed/refractory peripheral T-cell lymphoma (r/r PTCL).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age range from 18 to 75 years;
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
Pathologically confirmed relapsed/refractory Peripheral T-cell lymphoma (Including PTCL-NOS, AITL, anaplastic large cell lymphoma（ALTL）, excluding Nature Killer（NK）/T cell lymphoma);
At least one two-dimensional measurable lesion with a length diameter of at least 1.5cm and vertical diameter of at least 1.0cm (measured by CT or MRI);
Disqualifiers
Patients allergic of any drug in this regimen;
Previous treatment with anti-PD-1 antibody combined with HDAC inhibitor (Patients only received single agent of treatment regime or sequentially received anti-PD-1 and HDAC inhibitor are allowed to enroll);
Patients with clinically significant heart disease, including severe cardiac insufficiency: New York Heart Disease Association (NYHA) grade IV cardiac insufficiency, unstable angina. And myocardial infarction, congestive heart failure, and QTC interphase > 500ms which occurred before 6 month of screening;
Patients who have received grade II or above surgery within 3 weeks before enrollment;
Trial design
Design model
Single group
Treatments tested in this trial
PD-1 antibody+ HDAC inhibitor
DrugPatients receive anti-PD-1 antibody Sintilimab+ HDAC inhibitor Chidamide three weeks for a cycle, detailed as follows: * Anti-PD-1 antibody (Sintilimab): Fixed dose of 200 mg every 3 weeks, intravenous drip (without pretreatment), infusion time: 30 minutes (no less than 20 mins, no more than 60 mins), the maximum treatment period is 2 years (up to 35 doses), complete remission（CR）patients confirmed by imaging assessment can be considered off anti-PD-1 treatment after 12 treatment cycles. * Chidamide: Chidamide is administered orally at a dose of 30mg (initial dose). It is recommended to be administered within 0.5h after a meal with a fixed time. Chidamide will be given until disease progression or intolerant toxicity. The maximum treatment is 2 years. If chidamide therapy requires to be continued over 2 years due to clinical benefit, the prescription/decision should be made after discussion with the principal investigator.
Treatment groups
51 Participants
are divided into 1 treatment groupGroup A: Sinitilimab+ChidamideExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Progression Free Survival (PFS)
Time from the data of enrollment to of disease progression, or death of any cause, or date of lost follow-up, whichever comes first, otherwise subject data were censored at time last known disease free.
Time frame
Up to two years after the start of the studySecondary outcomes
1
Overall Survival (OS)
Time from the date of enrollment to data of death from any cause, or date of lost follow-up, whichever comes first, and otherwise censored at time last known alive.
Time frame
Up to two years after the start of the study2
incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
All the adverse events of the patients related will be assessed and graded by NCI CTCAE v 5.0\]
Time frame
Since the signing of informed consent forms to 30 days after the last cycle of treatment and 90 days after last dose of anti-PD-1 antibodyOther outcomes
1
biomarker
PD-L1, HDAC 3/4/10 expression, circulation tumor DNA（ctDNA）
Time frame
the collection of the samples will begin from the signing of informed consent forms（ICF）, and the detection will be competed within 3 months after the last patient discontinued the treatmentSponsors and contacts
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Source ClinicalTrials.gov