MALT Lymphoma of StomachPhase 2NCT06228963
Orelabrutinib in the Treatment of HP-positive Gastric MALT Lymphoma
A Phase 2 study testing Triple therapy for eradication of Helicobacter Pylori and Orelabrutinib and Triple therapy for eradication of Helicobacter Pylori in people with MALT Lymphoma of Stomach and Helicobacter Pylori Infection, run by Fudan University at 1 site in China.
Trial summary
Describe the efficacy and safety of Orelabrutinib in the treatment of HP-positive gastric MALT lymphoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MALT Lymphoma of Stomach, Helicobacter Pylori Infection
- What is being tested?
- Triple therapy for eradication of Helicobacter Pylori and Orelabrutinib and Triple therapy for eradication of Helicobacter Pylori
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- Mar 2024to Jan 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Yizhen Liu, 021-64175590 ext. 85100, aliuyz@126.com
About this study
Official title: 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
Read the 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
- Being tested
- Triple therapy for eradication of Helicobacter Pylori and Orelabrutinib, Triple therapy for eradication of Helicobacter Pylori
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triple therapy for eradication of Helicobacter Pylori and OrelabrutinibDrug
Also called anti-HP 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 PyloriDrug
Also called anti-HP
Triple therapy for H. pylori (oral administration for 2 weeks, followed by a 1-week break)
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Triple therapy for eradication of Helicobacter Pylori+Orelabrutinib Receives: Drug: Triple therapy for eradication of Helicobacter Pylori and Orelabrutinib |
| Control group | Active comparator | Triple therapy for eradication of Helicobacter Pylori Receives: Drug: Triple therapy for eradication of Helicobacter Pylori |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-months CR rate
the ratio of numbers of patients with complete response to all the participants receiving treatment
Measured: up to 6 months
Secondary outcomes (5)
3-months CR rate
the ratio of numbers of patients with complete response to all the participants
Measured: up to 3 months
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
Measured: 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)
the period from the date of patients sign informed consent to the observed event for any reason
Measured: 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
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
Measured: 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
Record the name of adverse events and number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: Throughout the treatment period, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study startMar 2024 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MALT Lymphoma of StomachStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yizhen Liu, Fudan University
- Investigators
- Yizhen Liu, M.D., Ph.D., Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06228963
- Sponsor's protocol ID
- iNHL-02
- Status last verified
- Feb 2024
- First submitted
- 12 Jan 2024
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orelabrutinib in the First-line Treatment of HP-positive Gastric MALT Lymphoma: a Multicenter, Open-label, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06228963
- Acronym / sponsor ID
- iNHL-02
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Mar 2024 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 29 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Triple therapy for eradication of Helicobacter Pylori and OrelabrutinibTriple therapy for eradication of Helicobacter Pylori+Orelabrutinib |
| Control group | Active comparator | Drug: Triple therapy for eradication of Helicobacter PyloriTriple therapy for eradication of Helicobacter Pylori |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triple therapy for eradication of Helicobacter Pylori and OrelabrutinibAlso: anti-HP and OrelabrutinibTriple 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) | Drug | Experimental group |
| Triple therapy for eradication of Helicobacter PyloriAlso: anti-HPTriple therapy for H. pylori (oral administration for 2 weeks, followed by a 1-week break) | Drug | Control group |
Primary outcome
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
5 secondary outcomes
3-months CR rate
Time frame: up to 3 months
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
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
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
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Throughout the treatment period, up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yizhen Liu, M.D., Ph.D. principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Triple therapy for eradication of Helicobacter Pylori and Orelabrutinib and Triple therapy for eradication of Helicobacter Pylori in people with MALT Lymphoma of Stomach and Helicobacter Pylori Infection, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yizhen Liu, M.D., Ph.D. (021-64175590 ext. 85100, aliuyz@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-months CR rate (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.