RecruitingPhase 2NCT06228963

Orelabrutinib in the Treatment of HP-positive Gastric MALT Lymphoma

Orelabrutinib in the First-line Treatment of HP-positive Gastric MALT Lymphoma: a Multicenter, Open-label, Randomized Controlled Trial

Sponsor

Fudan University

Enrollment

160 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

MALT Lymphoma of Stomach Helicobacter Pylori Infection

Summary

Describe the efficacy and safety of Orelabrutinib in the treatment of HP-positive gastric MALT lymphoma

Eligibility

Min Age: 18 Years

Inclusion Criteria7

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 Criteria7

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.

Interventions

DRUGTriple therapy for eradication of Helicobacter Pylori and Orelabrutinib

Triple therapy for H. pylori (oral administration for 2 weeks, followed by a 1-week break) plus Orelabrutinib for 8 weeks (or until progression, intolerable toxicity, death, or withdrawal from the study)

DRUGTriple therapy for eradication of Helicobacter Pylori

Triple therapy for H. pylori (oral administration for 2 weeks, followed by a 1-week break)