Actively Recruiting
A Multicenter, Prospective, Single-arm Clinical Study on the Treatment of Refractory/Relapsed Follicular Lymphoma With Chidamide Combined With Linperlisib
Led by The First Affiliated Hospital of Xiamen University · Updated on 2025-02-19
33
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
T
The First Affiliated Hospital of Xiamen University
Lead Sponsor
F
Fujian Provincial Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the safety and effectiveness of combining Chidamide with Linperlisib to treat patients with refractory and relapsed follicular lymphoma. This Phase 2, open-label trial aims to assess how well this drug combination works by measuring outcomes like complete response, overall survival, and progression-free survival. Participants will receive Chidamide orally twice a week at 20mg and Linperlisib once daily at 80mg following a schedule of two weeks on treatment and two weeks off, repeating every 28 days. This study is conducted at multiple centers under the sponsorship of The First Affiliated Hospital of Xiamen University. During the study, participants will undergo evaluations including imaging scans like CT or MRI to measure tumor lesions, as well as assessments of response rates and survival over up to 24 months. Researchers will monitor for any side effects and treatment safety throughout the trial period. Participants must be able to follow the study protocol and provide informed consent to join.
CONDITIONS
Brief Title
Chidamide Combined With Linperlisibon for the Treatment of Refractory/Relapsed Follicular Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with follicular lymphoma grade 1 to 3a and received at least second-line systemic treatment including anti-CD20 monoclonal antibody
- Age 18 years or older, any gender
- Estimated survival time of more than 3 months
- ECOG performance status of 2 or less
- Able to follow the study plan requirements
- At least one measurable lesion larger than specified sizes on CT or MRI
- Able to understand and voluntarily provide informed consent
You will not qualify if you...
- Central nervous system involvement, current or previous
- Evidence of transformation to more aggressive lymphoma subtype
- Impaired bone marrow or liver function beyond specified blood count and enzyme levels
- Abnormal coagulation tests or elevated serum amylase or lipase
- Active infections with HIV, hepatitis B or C, or CMV (with some exceptions for controlled HBV)
- Significant cardiovascular diseases or abnormal heart rhythms
- History of recent stroke or intracranial hemorrhage
- Major surgery within 4 weeks before enrollment
- Prior use of PI3K inhibitors with disease progression during treatment
- Recent systemic anti-tumor therapy or radiotherapy within 4 weeks
- Recent participation in other clinical trials or use of small molecular drugs
- Recent hematopoietic stem cell transplantation or active graft-versus-host disease
- Use of strong CYP3A4 inducers or inhibitors shortly before treatment
- Unrecovered toxic reactions from prior anti-tumor therapy except alopecia
- Uncontrolled systemic infections requiring intravenous antibiotics
- Other primary tumors needing active treatment
- Inability to take oral drugs due to gastrointestinal issues
- Pregnant or breastfeeding women
- Any other conditions judged by researchers to pose high risk or affect study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants receive Chidamide combined with Linperlisib in repeated 2-week on and 2-week off cycles as specified.
Regular visits during treatment cycles as per protocol
Trial Site Locations
Total: 1 location
1
Bing Xu
Xiamen, Fujian, China, 361000
Actively Recruiting
Research Team
B
Bing Xu
Z
Zhifeng Li
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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