Orelabrutinib in the Treatment of HP-positive Gastric MALT Lymphoma

Helicobacter Pylori Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06228963
• Other study ID #: iNHL-02
• Status: Recruiting
• Phase: Phase 2
• Start date: March 2024
• Est. completion date: January 2028

Study information

• Verified date: February 2024
• Source: Fudan University
• Contact: Yizhen Liu, M.D., Ph.D.
• Phone: 021-64175590
• Email: aliuyz[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: January 2028
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• Helicobacter Pylori Infection
• Lymphoma
• Lymphoma, B-Cell, Marginal Zone
• Lymphoma, Non-Hodgkin
• Stomach Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory biomarkers	Biomarkers for predictive factors of efficacy at baseline or during the treatment	Throughout the treatment period, up to 2 years
Primary	6-months CR rate	the ratio of numbers of patients with complete response to all the participants receiving treatment	up to 6 months
Secondary	3-months CR rate	the ratio of numbers of patients with complete response to all the participants	up to 3 months
Secondary	2-year progression-free survival (PFS)	the period from the date of patients sign informed consent to the observed progression of the disease or the occurrence of death for any reason	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
Secondary	2-year event-free survival (EFS)	the period from the date of patients sign informed consent to the observed event for any reason	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
Secondary	2-year overall survival rate	time between the date of patients sign informed consent and the date of death or the date of last follow-up time	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
Secondary	Number of participants with treatment-related adverse events as assessed by CTCAE v5.0	Record the name of adverse events and number of participants with treatment-related adverse events as assessed by CTCAE v5.0	Throughout the treatment period, up to 6 months