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New treatment option for Diffuse Large B-Cell Lymphoma
Official title Chidamide Maintenance for MRD-Positive Double-Expressor DLBCL in First Complete Remission
ClinicalTrials.gov ID: NCT07507318
What this study is testing
What is Chidamide?
Chidamide is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for diffuse large b-cell 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
- This is a prospective, multicenter, single-arm, open-label phase 2 study designed to evaluate the efficacy and safety of chidamide maintenance in adults with newly diagnosed double-expressor diffuse large B-cell lymphoma (DLBCL) who achieve complete response after induction therapy but remain ctDNA minimal residual disease (MRD)-positive. Eligible participants will receive oral chidamide 20 mg on Days 1, 4, 8, and 11 of each 21-day cycle.
- 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 to 80
You may be able to join if
- Histologically confirmed diffuse large B-cell lymphoma, CD20-positive.
- Double-expressor lymphoma confirmed by pathology, defined as MYC expression \>=40% and BCL2 expression \>=50% by immunohistochemistry.
- Complete response after initial induction therapy.
- Age \>=18 and \<=80 years.
- ECOG performance status 0-2.
You likely can't join if
- Failure to achieve complete response after initial induction therapy.
- Prior organ transplantation.
- Uncontrolled coagulopathy or active bleeding.
- Uncontrolled cardiovascular or cerebrovascular disease, including left ventricular ejection fraction \<50%, connective tissue disease, or severe...
- Major organ surgery within 6 weeks before screening.
- Screening laboratory abnormalities not attributable to lymphoma, including: neutrophil count \ 1.5 x upper limit of normal; ALT/AST \>2.5 x upper...
See the full eligibility criteria
- Histologically confirmed diffuse large B-cell lymphoma, CD20-positive.
- Double-expressor lymphoma confirmed by pathology, defined as MYC expression \>=40% and BCL2 expression \>=50% by immunohistochemistry.
- Complete response after initial induction therapy.
- Age \>=18 and \<=80 years.
- ECOG performance status 0-2.
- No prior history of malignant tumor and no concurrent malignancy.
- International Prognostic Index (IPI) score \>1.
- ctDNA MRD-positive at screening/enrollment.
- Life expectancy of at least 6 months, in the opinion of the investigator.
- Written informed consent provided before any study-specific procedure.
- Failure to achieve complete response after initial induction therapy.
- Prior organ transplantation.
- Uncontrolled coagulopathy or active bleeding.
- Uncontrolled cardiovascular or cerebrovascular disease, including left ventricular ejection fraction \<50%, connective tissue disease, or severe active infection.
- Major organ surgery within 6 weeks before screening.
- Screening laboratory abnormalities not attributable to lymphoma, including: neutrophil count \ 1.5 x upper limit of normal; ALT/AST \>2.5 x upper limit of normal, or \>5 x upper limit of normal in patients with hepatic...
- Active hepatitis B not meeting protocol-defined virologic criteria for enrollment; patients with positive HBsAg or positive HBcAb require HBV DNA testing and must meet protocol-specified thresholds.
- HIV infection.
- Ongoing antitumor therapy for lymphoma or another malignancy.
- Drug abuse or chronic alcohol abuse that may interfere with study evaluation.
- Psychiatric illness or any condition resulting in inability to comply with the protocol.
- Requirement for ongoing treatment with strong or moderate CYP3A inhibitors or inducers; patients exposed to these agents within 7 days before first study dose, or within fewer than 5 half-lives, are not eligible.
- Inability to swallow capsules or clinically significant gastrointestinal disorders that may affect drug absorption, including malabsorption syndrome, bariatric surgery, inflammatory bowel disease, or partial/complete...
- Any other uncontrolled medical condition that, in the investigator's judgment, may compromise safety, interfere with oral drug absorption or metabolism, or place the participant at excessive risk.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, 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 all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, 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.