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NCT Number: NCT06228963

Orelabrutinib in the Treatment of HP-positive Gastric MALT Lymphoma

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

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Key information

Conditions

MALT Lymphoma of Stomach Helicobacter Pylori Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location status: Recruiting

Location contact

Yizhen Liu

CONTACT

[email protected]

021-64175590 ext. 85100

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Triple therapy for eradication of Helicobacter Pylori and Orelabrutinib

Drug

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

Triple therapy for eradication of Helicobacter Pylori

Drug

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

Other names: anti-HP

Primary outcomes

  1. 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

Secondary outcomes

  1. 3-months CR rate

    Time frame: up to 3 months

    the ratio of numbers of patients with complete response to all the participants

  2. 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

  3. 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

  4. 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

  5. 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

Other outcomes

  1. Exploratory biomarkers

    Time frame: Throughout the treatment period, up to 2 years

    Biomarkers for predictive factors of efficacy at baseline or during the treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Yizhen Liu, M.D., Ph.D.

CONTACT

[email protected]

021-64175590 ext. 85100

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Jan 29, 2024
Registry last updated
Feb 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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