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Orelabrutinib in the Treatment of HP-positive Gastric MALT Lymphoma | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

NCT06228963•Fudan University

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

March 1, 2024

Primary Completion Date

January 1, 2026

Completion Date

January 1, 2028

Last Updated

February 23, 2024

Enrollment

160

ESTIMATED participants

Conditions

MALT Lymphoma of StomachHelicobacter Pylori Infection

Interventions

Triple therapy for eradication of Helicobacter Pylori and Orelabrutinib

DRUG

Triple therapy for eradication of Helicobacter Pylori

DRUG

Contacts

Yizhen Liu, M.D., Ph.D.

CONTACT

021-64175590 aliuyz@126.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 23, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Orelabrutinib in the Treatment of HP-positive Gastric MALT Lymphoma

Inclusion Criteria

Exclusion Criteria

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