Chidamide Combined With Linperlisibon for the Treatment of Refractory/Relapsed Follicular Lymphoma

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorThe First Affiliated Hospital of Xiamen University

About this trial

To observe the safety and efficacy of Chidamide combined with Linperlisib in the treatment of refractory and relapsed follicular lymphoma.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Chidamide combined with Linperlisib

Treatment groups

33 Participants
are divided into 1 treatment group

Sponsors and collaborators

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