Treatment of HP-positive gastric MALT lymphoma with Orelabrutinib
Orelabrutinib in the First-line Treatment of HP-positive Gastric MALT Lymphoma: a Multicenter, Open-label, Randomized Controlled Trial
This study is testing if a new treatment called Orelabrutinib, combined with standard therapy for Helicobacter pylori, can help people with HP-positive gastric MALT lymphoma feel better compared to usual treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | Orelabrutinib |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06228963 on ClinicalTrials.gov |
What this trial studies
This multicenter, open-label, randomized controlled trial evaluates the efficacy and safety of Orelabrutinib in patients with HP-positive gastric MALT lymphoma. Participants will receive a combination of triple therapy for Helicobacter pylori eradication along with Orelabrutinib as a first-line treatment. The study aims to determine how well this treatment works compared to standard approaches. Patients will be monitored for both effectiveness and safety throughout the trial.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with histologically confirmed gastric MALT lymphoma and current Helicobacter pylori infection.
Not a fit: Patients who are negative for Helicobacter pylori or have a history of other tumors may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients suffering from HP-positive gastric MALT lymphoma.
How similar studies have performed: While there have been studies on MALT lymphoma treatments, the specific use of Orelabrutinib in this context is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Shanghai, Shanghai Municipality
- Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: Yizhen Liu, M.D., Ph.D. — Fudan University
- Study coordinator: Yizhen Liu, M.D., Ph.D.
- Email: aliuyz@126.com
- Phone: 021-64175590
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.