Clinical trial NCT06228963: Orelabrutinib in the Treatment of HP-positive Gastric MALT Lymphoma
Official title: Orelabrutinib in the First-line Treatment of HP-positive Gastric MALT Lymphoma: a Multicenter, Open-label, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: MALT Lymphoma of Stomach
Helicobacter Pylori Infection
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2024-01-29
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: 6-months CR rate
timeFrame: up to 6 months
Secondary outcomes:
measure: 3-months CR rate
timeFrame: up to 3 months
measure: 2-year progression-free survival (PFS)
timeFrame: 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
measure: 2-year event-free survival (EFS)
timeFrame: 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
measure: 2-year overall survival rate
timeFrame: 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
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
timeFrame: Throughout the treatment period, up to 6 months
Other outcomes:
measure: Exploratory biomarkers
timeFrame: Throughout the treatment period, up to 2 years
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Fudan University
name: Yizhen Liu, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: