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Recruiting NCT06228963

Orelabrutinib in the Treatment of HP-positive Gastric MALT Lymphoma

Phase II Interventional MALT Lymphoma of Stomach Helicobacter Pylori Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Triple therapy for eradication of Helicobacter Pylori and Orelabrutinib, Triple therapy for eradication of Helicobacter Pylori.
Who it may be relevant to
Registry conditions: MALT Lymphoma of Stomach, Helicobacter Pylori Infection. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Detailed 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

Interventions

  • Drug Triple 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)
  • Drug Triple therapy for eradication of Helicobacter Pylori
    Triple therapy for H. pylori (oral administration for 2 weeks, followed by a 1-week break)

Primary outcome measures

  • 6-months CR rate [Time frame: up to 6 months]
Secondary outcome measures (5)
  • 3-months CR rate [Time frame: up to 3 months]
  • 2-year progression-free survival (PFS) [Time frame: From date of patients sign informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years]
  • 2-year event-free survival (EFS) [Time frame: From date of patients sign informed consent until the date of first documented event, progression or date of death from any cause, whichever came first, assessed up to 2 years]
  • 2-year overall survival rate [Time frame: From date of patients sign informed consent until the date of death or the date of last follow-up time, whichever came first, assessed up to 2 years]
  • Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [Time frame: Throughout the treatment period, up to 6 months]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Fudan University Shanghai Cancer Center — Shanghai

Identifiers

NCT: NCT06228963 · iNHL-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗