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

NCT06158386 | Recruiting Phase 2

• 1 other identifier: XMDYYYXYK-03
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Follicular Lymphoma; Refractory B-Cell Lymphoma; Relapsed Non-Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

• Complete response rate (CR)

  CR was defined as the percentage of participants who achieved CR, using the Lugano criteria.

  Up to 24 months

Secondary Outcomes (3)

• Overall response rate (ORR)

  Up to 24 months

• Progressive free survival (PFS)

  Up to 24 months

• Overall survival (OS)

  Up to 24 months

Study Arms (1)

Chidamide combined with Linperlisib

EXPERIMENTAL

Drug: Chidamide combined with Linperlisib

Interventions

Chidamide combined with Linperlisib DRUG

Specified 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.

Chidamide combined with Linperlisib

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Be able to follow the requirements of the research plan.
• The patients have at least one measurable lesion (any length of lymph node lesion \> 1.5cm or any length of extranodal lesion \> 1 cm) examined by computed tomography (CT)/ magnetic resonance imaging (MRI).
• Be able to understand and voluntarily provide informed consent.

You may not qualify if:

• 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.
• Patients with active infection of the human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV), if patients with HBV infection with HBsAg or hepatitis B core antibody (HBcAb) positive\] but HBV DNA negative can be included, However, these patients need continuous antiviral treatment and HBV DNA PCR detection every cycle after enrollment.
• Patients with CMV infection (IgM positive or CMV DNA was positive by PCR.)
• Meet any of the following criteria related to visceral function: all kinds of clinically significant abnormal rhythm or conduction need clinical pre-diagnosis Hereditary QT interval syndrome or QTcF\>480 msec or taking drugs that may cause Qt interval delay or torsade de pointes. A variety of clinically significant cardiovascular diseases, including acute myocardial infarction, unstable angina, and coronary artery bypass grafting in the first 6 months of the group, with New York's cardiology (NYHA) classification of grade 3 or above. Left ventricular ejection fraction (LVEF )\<40%, or uncontrolled blood pressure controlled by drugs (Systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mgHg).
• Have a history of stroke or intracranial hemorrhage within 6 months before drug administration for the first time.
• Major surgery was performed within 4 weeks before enrollment.
• Any PI3K inhibitor has been used before and the disease has progressed during the treatment period (within 6 months after the last use).
• Received systemic anti-tumor therapy or radiotherapy within 4 weeks before enrollment.
• The last time you participated in clinical trials of other drugs before enrollment was less than 2 weeks or the last time you used small molecular drugs (such as antibody drugs) was less than 4 weeks.
• The patients received the transplantation of somatic hematopoietic stem cells within 3 months before enrollment.
• Patients received allogeneic hematopoietic stem cell transplantation or had any active graft-versus-host disease within 6 months before drug administration.
• Take a strong inducer or inhibitor of cytochrome P4503A4 (CYP3A4) within 2 weeks before the first drug administration (3 weeks for Hypericum perforatum)

Sponsors & Collaborators

• The First Affiliated Hospital of Xiamen University: lead
• 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

Study Sites (1)

Bing Xu

Xiamen, Fujian, 361000, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Follicular; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Bing Xu

CONTACT

+8618750918842; xubingzhangjian@126.com

Zhifeng Li

CONTACT

+8613606901162; lzf_xm@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: December 6, 2023
• Study Start: November 22, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)