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New treatment option for Follicular Lymphoma
Official title Chidamide Combined With Linperlisibon for the Treatment of Refractory/Relapsed Follicular Lymphoma
ClinicalTrials.gov ID: NCT06158386
What this study is testing
What is Chidamide combined with Linperlisib?
Chidamide combined with Linperlisib is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for follicular lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To observe the safety and efficacy of Chidamide combined with Linperlisib in the treatment of refractory and relapsed follicular lymphoma.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join 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...
- 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.
You likely can't join if
- CNS involvement (current or previous).
- Clinical evidence of transformation to a more aggressive subtype of lymphoma
- Impaired bone marrow function: neutrophils \ 1.5 x ULN or serum ALT and AST \> 2.5x ULN, Patients with liver infiltration by lymphoma, AST and ALT \>...
- 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...
- Patients with CMV infection (IgM positive or CMV DNA was positive by PCR.)
See the full eligibility criteria
- 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...
- 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.
- CNS involvement (current or previous).
- Clinical evidence of transformation to a more aggressive subtype of lymphoma
- Impaired bone marrow function: neutrophils \ 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...
- 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...
- 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 study team makes the final eligibility decision.
Where it's taking place
- Xiamen, Fujian, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Xiamen, Fujian, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.