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).
Peripheral T-cell lymphoma accounts for 12-15% of non-Hodgkin's lymphomas in western countries, however, this number is up to 35% or more in some Asian countries, including China. According to the 2016 World Health Organization annual classification, there are 29 subtypes of peripheral T cell lymphoma, among which the most common types are peripheral T cell lymphoma non-specific type (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL) and anaplastic large cell lymphoma (ALCL). For r/r PTCL, the prognosis was poor with objective response rate range from 8-50% and median progression free survival(PFS)range from 3.2-5 months for chemotherapy. Thus, the treatment of this patient population remained clinically unmet need. This clinical trial will be conducted under Simon's optimal two-stage design. The first stage needs 15 participants, if ≥5 participants acquire remission, the study will move on to the second stage and enroll another 36 patients to achieve a total number of 51 participants enrolled. Drop rate is assumed to be 10%, to insure 47 participants involving the efficacy evaluation statistically. Participants will receive anti-PD-1 antibody plus HDAC inhibitor every three weeks for a cycle, until disease progression or severe/ intolerant toxicity, the maximum treatment period is 2 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
51
Patients 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.
Dongmei Ji
Shanghai, Shanghai Municipality, China
RECRUITINGProgression 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 study
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 study
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 antibody
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.