Orelabrutinib in the Treatment of HP-positive Gastric MALT Lymphoma

Recruiting now · Phase 2

Conditions studied: MALT Lymphoma of Stomach, Helicobacter Pylori Infection

In brief

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

Key facts

Study ID

NCT06228963

Run by

Fudan University

People needed

160

Starts

2024-03-01

Expected to finish

2028-01-01

Last updated by the study team

2024-02-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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