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New treatment option for Marginal Zone Lymphoma(MZL)
Official title Application of Orelabrutinib With or Without CD20 Monoclonal Antibody in Previously Untreated Marginal Zone Lymphoma
ClinicalTrials.gov ID: NCT07355699
What this study is testing
What is Orelabrutinib?
Orelabrutinib is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for marginal zone lymphoma(mzl).
Also referred to as Rituximab, Obinutuzumab.
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 study focuses on treatment-naïve marginal zone lymphoma (MZL) patients and aims to investigate the efficacy and safety of orelabrutinib combined with or without CD20 monoclonal antibody. This is a single-arm study without a control group.
- Phase 4: studies an already-approved treatment
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
You may be able to join if
- Age ≥ 18 years;
- Pathologically confirmed marginal zone lymphoma;
- Presence of evaluable lesions;
- Meets indications for treatment: Fulfills the GELF criteria OR has disease-related clinical symptoms/organ function impairment;
- Patients who are unsuitable for local radiotherapy, refuse local radiotherapy, or have disease progression after local therapy. Cases considered...
You likely can't join if
- Currently diagnosed with another malignant tumor;
- Central nervous system involvement by lymphoma or transformation to a higher grade;
- Allergy to any of the investigational drugs;
- Active infection or uncontrolled HBV infection, HIV/AIDS, or other serious infectious diseases;
- Pregnancy, lactating women, or people of childbearing potential unwilling to use contraception;
- Other situations deemed by the investigator as unsuitable for participation in this trial.
See the full eligibility criteria
- Age ≥ 18 years;
- Pathologically confirmed marginal zone lymphoma;
- Presence of evaluable lesions;
- Meets indications for treatment: Fulfills the GELF criteria OR has disease-related clinical symptoms/organ function impairment;
- Patients who are unsuitable for local radiotherapy, refuse local radiotherapy, or have disease progression after local therapy. Cases considered unsuitable for local radiotherapy include the following: Gastric MALT MZL...
- ECOG score of 0-3;
- Expected survival time ≥ 3 months;
- Ability to provide signed informed consent.
- Currently diagnosed with another malignant tumor;
- Central nervous system involvement by lymphoma or transformation to a higher grade;
- Allergy to any of the investigational drugs;
- Active infection or uncontrolled HBV infection, HIV/AIDS, or other serious infectious diseases;
- Pregnancy, lactating women, or people of childbearing potential unwilling to use contraception;
- Other situations deemed by the investigator as unsuitable for participation in this trial.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, 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.