Status:
RECRUITING
Chidamide Combined With Linperlisibon for the Treatment of Refractory/Relapsed Follicular Lymphoma
Lead Sponsor:
The First Affiliated Hospital of Xiamen University
Collaborating Sponsors:
Fujian Provincial Hospital
Fujian Cancer Hospital
Conditions:
Follicular Lymphoma
Refractory B-Cell Lymphoma
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
To observe the safety and efficacy of Chidamide combined with Linperlisib in the treatment of refractory and relapsed follicular lymphoma.
Detailed Description
This is a Phase 2, open-label clinical trial study that aims to evaluate the efficacy (eg. Complete response, Overall Survival, Progression Free Survival) and adverse effects of Chidamide combined wit...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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)
- Before the first drug administration, the toxic reaction of previous anti-tumor therapy has not recovered to ≤1 level (except alopecia).
- Patients with uncontrolled systemic infection requiring intravenous antibiotic treatment.
- Currently suffering from other primary tumors that need active treatment according to the guidelines.
- Inability to take drugs orally, previous surgical history, or serious gastrointestinal diseases such as dysphagia and active gastric ulcer may affect the absorption of drugs.
- Pregnant (serum pregnancy test results are positive) or lactating women
- Any other diseases, abnormal metabolism, abnormal physical examination, or abnormal laboratory examination with significant clinical significance, according to the researcher's judgment, it is reasonable to suspect that the patient has a certain disease or state that is not suitable for using these two drugs, or it will affect the interpretation of the research results or put the patient in a high-risk situation.
Key Trial Info
Start Date :
November 22 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT06158386
Start Date
November 22 2023
End Date
December 31 2027
Last Update
February 19 2025
Active Locations (1)
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1
Bing Xu
Xiamen, Fujian, China, 361000