Orelabrutinib in the Treatment of HP-positive Gastric MALT Lymphoma (NCT06228963) | Clinical Trial Compass
RecruitingPhase 2
Orelabrutinib in the Treatment of HP-positive Gastric MALT Lymphoma
China160 participantsStarted 2024-03
Plain-language summary
Describe the efficacy and safety of Orelabrutinib in the treatment of HP-positive gastric MALT lymphoma
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18 years old
* Histologically confirmed gastric mucosa-associated lymphoid tissue (MALT) lymphoma;
* Current infection with Helicobacter pylori (Hp): Diagnosis can be made if any of the following criteria are met: a) Positive result in at least one of the following: RUT (rapid urease test), histological staining, or bacterial culture of gastric mucosal tissue; b) Positive result in 13C or 14C-UBT (urea breath test); c) Positive result in HpSA detection. A positive result in serum Hp antibody test indicates past infection, and patients who have never been treated can be considered as having current infection.
* ECOG (Eastern Cooperative Oncology Group) performance status 0-2.
* Lugano staging I-II1.
* Signed informed consent form.
* Evaluable lesions present.
Exclusion Criteria:
* Negative for Helicobacter pylori (HP);
* History of other tumors, except for cured cervical cancer or basal cell carcinoma of the skin;
* Patients with active HIV and syphilis infections;
* Pregnant or lactating women;
* Patients with severe active infections;
* Patients with multiple factors affecting oral medication (such as dysphagia, nausea, vomiting, chronic diarrhea, and intestinal obstruction);
* Other comorbidities or conditions that may prevent patients from completing the clinical trial.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.