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Orelabrutinib in the Treatment of HP-positive Gastric MALT Lymphoma

Orelabrutinib in the Treatment of HP-positive Gastric MALT Lymphoma

Recruiting
18 years and older
All
Phase 2

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Overview

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

Description

This multicenter, open-label, randomized controlled trial is trying to evaluate the efficacy and safety of Orelabrutinib in the first-line treatment of HP-positive gastric MALT lymphoma

Eligibility

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.

Study details
    MALT Lymphoma of Stomach
    Helicobacter Pylori Infection

NCT06228963

Fudan University

7 March 2024

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