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Trial Title:
Orelabrutinib in the Treatment of HP-positive Gastric MALT Lymphoma
NCT ID:
NCT06228963
Condition:
MALT Lymphoma of Stomach
Helicobacter Pylori Infection
Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell, Marginal Zone
Lymphoma, Non-Hodgkin
Stomach Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Triple therapy for eradication of Helicobacter Pylori and Orelabrutinib
Description:
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)
Arm group label:
Experimental group
Other name:
anti-HP and Orelabrutinib
Intervention type:
Drug
Intervention name:
Triple therapy for eradication of Helicobacter Pylori
Description:
Triple therapy for H. pylori (oral administration for 2 weeks, followed by a 1-week
break)
Arm group label:
Control group
Other name:
anti-HP
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
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Yizhen Liu
Phone:
021-64175590
Phone ext:
85100
Email:
aliuyz@126.com
Start date:
March 2024
Completion date:
January 2028
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06228963
