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New treatment option for Diffuse Large B-Cell Lymphoma (DLBCL)
Official title Chidamide Combination With R-mini CHOP Followed by Chidamide+CD20 Maintenance in Elderly Newly Diagnosed MYC/BCL2+ DLBCL
ClinicalTrials.gov ID: NCT07493148
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 (dlbcl).
Also referred to as CS055, HBI-8000.
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
- Efficacy and safety of chidamide in combination with the R-mini CHOP regimen, followed by chidamide plus CD20 monoclonal antibody as maintenance therapy, in elderly patients with newly diagnosed MYC/BCL2 double-expressor DLBCL.
- 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 70 and older
You may be able to join if
- Age ≥ 70 years;
- No prior treatment for DLBCL;
- Histopathologically confirmed diagnosis (all of the following conditions must be met simultaneously): ① Diffuse large B-cell lymphoma, not otherwise...
- At least one 18F-fluorodeoxyglucose (18FDG)-avid lesion on positron emission tomography-computed tomography (PET-CT) according to the 2014 Lugano...
- International Prognostic Index (IPI) score \> 1;
You likely can't join if
- Central nervous system (CNS) involvement;
- Transformed lymphoma, i.e., lymphoma transformed from other lymphoma types such as follicular lymphoma, marginal zone B-cell lymphoma, or chronic...
- Uncontrolled cardiovascular or cerebrovascular diseases, coagulation disorders, autoimmune diseases, or severe infectious diseases;
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies, or known sensitivity or allergic reactions to...
- HIV/HCV infection;
- If HBsAg is positive, HBV DNA testing is required; patients with negative DNA may be enrolled. If HBsAg is negative but HBcAb is positive (regardless...
See the full eligibility criteria
- Age ≥ 70 years;
- No prior treatment for DLBCL;
- Histopathologically confirmed diagnosis (all of the following conditions must be met simultaneously): ① Diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS), and CD20-positive; ② "MYC/BCL2...
- At least one 18F-fluorodeoxyglucose (18FDG)-avid lesion on positron emission tomography-computed tomography (PET-CT) according to the 2014 Lugano classification for Hodgkin and non-Hodgkin lymphoma;
- International Prognostic Index (IPI) score \> 1;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2;
- At screening, laboratory tests must meet the following criteria, unless judged by the investigator to be due to lymphoma (no corrective or supportive treatment for the indicators below within 2 weeks prior to...
- Life expectancy ≥ 6 months;
- Understand and voluntarily sign a written informed consent form.
- Central nervous system (CNS) involvement;
- Transformed lymphoma, i.e., lymphoma transformed from other lymphoma types such as follicular lymphoma, marginal zone B-cell lymphoma, or chronic lymphocytic leukemia/small lymphocytic lymphoma; specific subtypes of...
- Uncontrolled cardiovascular or cerebrovascular diseases, coagulation disorders, autoimmune diseases, or severe infectious diseases;
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies, or known sensitivity or allergic reactions to murine products; contraindications to any component of the CHOP regimen or...
- HIV/HCV infection;
- If HBsAg is positive, HBV DNA testing is required; patients with negative DNA may be enrolled. If HBsAg is negative but HBcAb is positive (regardless of HBsAb status), HBV DNA testing is required; patients with negative...
- Uncontrolled cardiovascular or cerebrovascular diseases, coagulation disorders, autoimmune diseases, or severe infectious diseases;
- Inability to comply with the study protocol due to psychiatric or other unknown reasons;
- For female patients of childbearing potential or male patients with partners of childbearing potential, unwillingness or inability to use effective contraception throughout the study treatment period and for 12 weeks...
- Other conditions deemed unsuitable for participation in this trial.
The study team makes the final eligibility decision.
Where it's taking place
- Changchun, Jilin, 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, 70 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Changchun, Jilin, 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.