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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06228963
Other study ID # iNHL-02
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


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
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