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Follicular LymphomaPhase 2NCT06158386

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

A Phase 2 study testing Chidamide combined with Linperlisib in people with Follicular Lymphoma and Refractory B-Cell Lymphoma, run by The First Affiliated Hospital of Xiamen University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

To observe the safety and efficacy of Chidamide combined with Linperlisib in the treatment of refractory and relapsed follicular lymphoma. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Chidamide combined with Linperlisib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteChina
Study dates
22 Nov 2023to 31 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.)
Show all 21Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Bing Xu contact

+8618750918842

xubingzhangjian@126.com

Zhifeng Li contact

+8613606901162

lzf_xm@163.com

China1 site, 1 recruiting

  • Bing Xu

    Xiamen, Fujian, 361000

    Bing Xu, +8618750918842, xubingzhangjian@126.com

    Zhifeng Li, +8613606901162, lzf_xm@163.com

    Recruiting

Other trials in China

About this study

Official title: A Multicenter, Prospective, Single-arm Clinical Study on the Treatment of Refractory/Relapsed Follicular Lymphoma (R/RFL) With Chidamide Combined With Linperlisib

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

Read the 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 with Linperlisib in the treatment of refractory and relapsed follicular lymphoma.

Being tested
Chidamide combined with Linperlisib
Medical subject headings
Lymphoma, Follicular, Lymphoma, B-Cell, Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chidamide combined with LinperlisibDrug

    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.

Study groups in NCT06158386
Study groupRoleWhat they receive
Chidamide combined with LinperlisibExperimentalNot described
Receives: Drug: Chidamide combined with Linperlisib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete response rate (CR)

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

    Measured: Up to 24 months

Secondary outcomes (3)

  1. Overall response rate (ORR)

    Percentage of participants with best overall response of partial response (PR) and complete response (CR), using the Lugano criteria.

    Measured: Up to 24 months

  2. 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.

    Measured: Up to 24 months

  3. 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.

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2023
  2. Study start22 Nov 2023
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
33 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06158386
Sponsor's protocol ID
XMDYYYXYK-03
Status last verified
Feb 2025
First submitted
21 Nov 2023
Last updated
19 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Chidamide combined with Linperlisib in people with Follicular Lymphoma and Refractory B-Cell Lymphoma, run by The First Affiliated Hospital of Xiamen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Bing Xu (+8618750918842, xubingzhangjian@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete response rate (CR) (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06158386.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.

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