To observe the safety and efficacy of Chidamide combined with Linperlisib in the treatment of refractory and relapsed follicular lymphoma.
The patients diagnosed with follicular lymphoma with grade 1-3a, have received at least second-line systemic treatment, and at least one of the first-line treatments includes anti-CD20 monoclonal antibody (anti-CD20 monoclonal antibody monotherapy or combined chemotherapy). If the latest histopathological diagnosis is more than 6 months, a lymph node or tissue puncture or biopsy (resection or coarse needle puncture) must be performed.
Age ≥18 years old, regardless of gender.
The estimated survival time is more than 3 months.
ECOG ≤ 2.
CNS involvement (current or previous).
Clinical evidence of transformation to a more aggressive subtype of lymphoma
Impaired bone marrow function: neutrophils < 1.5× 10*9/L, HB < 80 g/L, PLT < 75×10*9 /L, Impaired liver function, defined as serum total bilirubin > 1.5 x ULN or serum ALT and AST > 2.5x ULN, Patients with liver infiltration by lymphoma, AST and ALT > 5x ULN, Renal glomerular filtration rate (eGFR) < 30 ml/min.
PT INR>1.5ULN or APTT> 1.5 ULN, Serum amylase or lipase > 1ULN.
Single group
Chidamide combined with Linperlisib
DrugSpecified dose on specified days: Cedarbenzamide (C) 20mg orally twice weekly, Limplica (L) 80mg once daily, 2 weeks on 2 weeks off, Repeat on day 28.
Complete response rate (CR)
CR was defined as the percentage of participants who achieved CR, using the Lugano criteria.
Overall response rate (ORR)
Percentage of participants with best overall response of partial response (PR) and complete response (CR), using the Lugano criteria.
Progressive free survival (PFS)
PFS was defined as the time from the date of treatment initiation to the date of first documentation of definitive disease progression (PD) or date of death from any cause, whichever occurs first.
Overall survival (OS)
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.
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The First Affiliated Hospital of Xiamen University
Lead sponsor
Fujian Provincial Hospital
Collaborator
Fujian Cancer Hospital
Collaborator
Zhangzhou Affiliated Hospital of Fujian Medical University
Collaborator
Jieyang People's Hospital
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
