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New treatment option for Diffuse Large B-Cell Lymphoma (DLBCL)
Official title Genetic Subtype-matched Targeted Therapy for the Treatment of Newly Diagnosed DLBCL With TP53 Mutation
ClinicalTrials.gov ID: NCT07499271
What this study is testing
What is POLA-R-CHP?
POLA-R-CHP is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for diffuse large b-cell lymphoma (dlbcl).
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 evaluate the efficacy and safety of Genetic subtype-matched targeted therapy in the treatment of treatment-naive diffuse large B-cell lymphoma with TP53 mutation.
- 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 70
You may be able to join if
- Patients aged 18 years and older, up to 70 years.
- Participants must be able to understand and willing to sign the written informed consent form.
- Eastern Cooperative Oncology Group performance status 0 to 3.
- Life expectancy ≥3 months (as determined by the investigator).
- Pathologically (histologically or cytologically) confirmed treatment-naive CD20-positive diffuse large B-cell lymphoma.
You likely can't join if
- Patients who have previously received systemic anti-tumor therapy.
- Patients with central nervous system involvement.
- Patients who received systemic adrenal corticosteroids for more than 5 days within 14 days prior to study drug administration, or who require daily...
- Active concurrent malignancy requiring active treatment.
- Uncontrolled or severe cardiovascular disease, including (but not limited to) any of the following: congestive heart failure (NYHA class III or IV)...
- Uncontrolled infection or infection requiring intravenous antibiotic therapy.
See the full eligibility criteria
- Patients aged 18 years and older, up to 70 years.
- Participants must be able to understand and willing to sign the written informed consent form.
- Eastern Cooperative Oncology Group performance status 0 to 3.
- Life expectancy ≥3 months (as determined by the investigator).
- Pathologically (histologically or cytologically) confirmed treatment-naive CD20-positive diffuse large B-cell lymphoma.
- Measurable disease defined by PET-CT as a short-axis diameter of at least ≥1.5 cm.
- Bone marrow and organ function meeting the following criteria (without blood transfusion, G-CSF, or medication correction within 14 days prior to screening): Bone marrow function: Absolute neutrophil count ≥1.5×10⁹/L...
- Females of childbearing potential must agree to use highly effective contraceptive methods during the treatment period and for 5 weeks after the last dose of study drug. Sexually active males must agree to use highly...
- No difficulty swallowing oral tablets/capsules.
- Good compliance and willingness to adhere to visit schedules, dosing schedules, laboratory tests, and other examination procedures.
- Patients who have previously received systemic anti-tumor therapy.
- Patients with central nervous system involvement.
- Patients who received systemic adrenal corticosteroids for more than 5 days within 14 days prior to study drug administration, or who require daily doses of \>10 mg of dexamethasone or equivalent drugs to control...
- Active concurrent malignancy requiring active treatment.
- Uncontrolled or severe cardiovascular disease, including (but not limited to) any of the following: congestive heart failure (NYHA class III or IV); myocardial infarction; unstable angina; or presence of arrhythmia...
- Uncontrolled infection or infection requiring intravenous antibiotic therapy.
- Chronic hepatitis B carriers with active hepatitis B or hepatitis C infection (hepatitis B: acute hepatitis B, untreated chronic hepatitis B virus infection, HBV-DNA ≥ the detection limit of the respective center...
- Clinically significant gastrointestinal abnormalities that may affect drug intake, transport, or absorption (such as active gastrointestinal inflammation, chronic diarrhea, intestinal obstruction, etc.), or patients...
- Patients with a history of bleeding disorders, or patients requiring long-term oral anticoagulation due to comorbidities.
- Female people who are currently pregnant or breastfeeding.
- Allergy to the study drug or excipients.
- Patients with active psychiatric disorders, alcohol dependence, drug dependence, or substance abuse.
- Presence of any life-threatening disease, medical condition, or organ system dysfunction that, in the investigator's opinion, may affect patient safety or compliance with study procedures.
- Other conditions that, in the investigator's opinion, make the patient unsuitable for participation in this clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- Suzhou, Jiangsu, 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 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Suzhou, Jiangsu, 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.