Orelabrutinib in the Treatment of HP-positive Gastric MALT Lymphoma

February 21, 2024 updated by: Yizhen Liu, Fudan University

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

Describe the efficacy and safety of Orelabrutinib in the treatment of HP-positive gastric MALT lymphoma

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yizhen Liu, M.D., Ph.D.
  • Phone Number: 85100 021-64175590
  • Email: aliuyz@126.com

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
Triple therapy for eradication of Helicobacter Pylori+Orelabrutinib
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)
Other Names:
  • anti-HP and Orelabrutinib
Active Comparator: Control group
Triple therapy for eradication of Helicobacter Pylori
Drug: Triple therapy for eradication of Helicobacter Pylori
Triple therapy for H. pylori (oral administration for 2 weeks, followed by a 1-week break)
Other Names:
  • anti-HP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6-months CR rate
Time Frame: up to 6 months
the ratio of numbers of patients with complete response to all the participants receiving treatment
up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2-year progression-free survival (PFS)
Time Frame: 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
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
2-year event-free survival (EFS)
Time Frame: 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
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
3-months CR rate
Time Frame: up to 3 months
the ratio of numbers of patients with complete response to all the participants
up to 3 months
2-year overall survival rate
Time Frame: 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
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
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time Frame: Throughout the treatment period, up to 6 months
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exploratory biomarkers
Time Frame: Throughout the treatment period, up to 2 years
Biomarkers for predictive factors of efficacy at baseline or during the treatment
Throughout the treatment period, up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

  • Principal Investigator: Yizhen Liu, M.D., Ph.D., Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

January 12, 2024

First Submitted That Met QC Criteria

January 25, 2024

First Posted (Actual)

January 29, 2024

Study Record Updates

Last Update Posted (Estimated)

February 23, 2024

Last Update Submitted That Met QC Criteria

February 21, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • iNHL-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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