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Marginal Zone LymphomaPhase 2NCT06566807

Oxygen Study-Orelabrutinib Combined With Obinutuzumab(O2) for First-Line Treatment of Marginal Zone Lymphoma

A Phase 2 study testing Orelabrutinib, obinutuzumab in people with Marginal Zone Lymphoma, run by Huai'an First People's Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a multi-center, prospective study. The main purpose is to evaluate the efficacy and safety of Orelabrutinib combined with Obinutuzumab for previously untreated MZL. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Marginal Zone Lymphoma
What is being tested?
Orelabrutinib, obinutuzumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
1 siteChina
Study dates
25 Aug 2024to 10 Aug 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

  • Aged ≥18 years, gender not limited;
  • Histopathologically confirmed CD20-positive marginal zone lymphoma including MALT, SMZL, NMZL;
  • MZL that has progressed, recurred, or is not suitable for local treatment after previous local treatment (local treatments include surgery, radiotherapy, Helicobacter pylori treatment, and hepatitis C treatment);
  • ECOG 0-2;
  • Indication for treatment as judged by the investigator (symptomatic, with cytopenia, at risk of end-organ damage, bulky disease, persistent progression, or patient\'s desire for treatment);
  • Major organ function meets the following criteria: a) Complete blood count: Absolute neutrophil count ≥1.5×10^9/L, platelets ≥75×10^9/L, hemoglobin ≥75g/L; if accompanied by bone marrow invasion, absolute neutrophil count ≥1.0×10^9/L, platelets ≥50×10^9/L, hemoglobin ≥50g/L; b) Blood biochemistry: Total bilirubin ≤1.5 ULN, AST or ALT ≤2 ULN; serum creatinine ≤1.5 ULN; serum amylase ≤ULN; c) Coagulation function: International normalized ratio (INR) ≤1.5 ULN.
  • Expected survival time ≥3 months;
  • Voluntarily sign a written informed consent form before the trial screening.

Who cannot join

  • Currently or previously diagnosed with other malignant tumors, unless curative treatment has been performed and there is evidence of no recurrence or metastasis within the last 5 years;
  • Lymphoma involving the central nervous system or transformation to a higher grade;
  • Active bleeding within 2 months prior to screening, or currently taking anticoagulant medications, or the investigator considers there to be a definite bleeding tendency;
  • Major surgery within 6 weeks prior to screening or minor surgery within 2 weeks prior to screening;
  • Active infection or uncontrolled HBV (positive for HBsAg and/or HBcAb and positive for HBV DNA titer), HCV Ab positive, HIV/AIDS, or other serious infectious diseases;
  • Any mental or cognitive disorder that may limit the understanding, execution, and compliance with the informed consent form and the study;
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  • Pregnant or lactating women and women of childbearing age who are unwilling to take contraceptive measures;
  • Need to continuously take drugs with moderate to severe inhibitory or strong inductive effects on cytochrome P450 CYP3A;
  • Other conditions that the investigator considers unsuitable for participating in this trial.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Chunling Wang contact

15189552696

wcl6506@163.com

China1 site, 1 recruiting

  • The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University#Huai'an First People's Hospital#

    Huai'an, Jiangsu, 210000

    Chunling Wang, 15189552696 wcl6, wcl6506@163.com

    Recruiting

Other trials in China

About this study

Official title: Oxygen Study-Orelabrutinib Combined With Obinutuzumab(O2) for First-Line Treatment of Marginal Zone Lymphoma: A Phase 2, Single-Arm, Prospective, Multicenter Clinical Study

This is a multi-center, prospective study. The main purpose is to evaluate the efficacy and safety of Orelabrutinib combined with Obinutuzumab for previously untreated MZL.

Read the detailed description

Marginal zone lymphoma (MZL) is a relatively common type of B-cell non-Hodgkin lymphoma (B-NHL), with an incidence rate second only to diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL). It is divided into three subtypes based on different clinical manifestations and pathological characteristics: mucosa-associated lymphoid tissue lymphoma (MALT), also known as extranodal marginal zone lymphoma, nodal marginal zone lymphoma (NMZL), and splenic marginal zone lymphoma (SMZL). Currently, there is no unified and standardized treatment plan for newly diagnosed MZL. Although high-intensity immunochemotherapy regimens have a high remission rate, they also bring higher treatment-related safety risks. Therefore, exploring effective chemotherapy-free regimens for MZL patients is an attempt with scientific value and clinical significance. With the development of new drugs, new drug regimens have become prominent in the treatment of MZL, and there is an increasing amount of research data on BTK inhibitors in the field of MZL. The BTK inhibitor Orelabrutinib has shown good efficacy in MZL and has been approved by the NMPA for the treatment of MZL in patients who have received at least one prior treatment.

This study is a multi-center, prospectivet clinical study for previously untreated MZL.

The patients will be treated with 6 cycles of O2 regimen. Patients with CR/PR after 6 cycles of O2 treatment will be treated with 1 year of single-agent orelabrutinib regimen.

Being tested
Orelabrutinib, obinutuzumab
Keywords
orelabrutinib, Marginal Zone Lymphoma
Medical subject headings
Lymphoma, B-Cell, Marginal Zone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Orelabrutinib, obinutuzumabDrug

    orelabrutinib，150mg，D1-D28 obinutuzumab，1000mg，D1、D8、D15/cycle1 D1/cycle2-6 . The patients will be treated with 6 cycles of O2 regimen. Patients with CR/PR after 6 cycles of O2 treatment will be treated with 1 year of single-agent orelabrutinib regimen.

Study groups in NCT06566807
Study groupRoleWhat they receive
O2ExperimentalNot described
Receives: Drug: Orelabrutinib, obinutuzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall response rate (ORR)

    The ORR is defined as the proportion of patients with a response of CR or PR

    Measured: At the end of Cycle 6 (each cycle is 28 days)

Secondary outcomes (9)

  1. the complete response rate

    CRR is defined as the proportion of patients with a response of CR

    Measured: (up to 2 year)

  2. BOR

    The BOR is defined as the proportion of patients with a best response of CR or PR

    Measured: Up to 2 years

  3. Duration of Response (DOR)

    Duration of response as defined as the period from the first response (at least PR) to treatment until evidence of disease progression, relapse or death of any cause.

    Measured: [ Time Frame: Up to 3 years ]

  4. TTR

    TTR is defined as the time from registration to the first response.

    Measured: [ Time Frame: Up to 3 years ]

  5. 24-month time to CR TTCR24

    TTCR24 is defined as the time from registration to the first complete response Within 24 months.

    Measured: Up to 2 years

  6. CR at 24 months (CR24)

    CR24 is defined as the proportion of patients with a response of CR at 24 months

    Measured: at 24 months

  7. 2 years progression-free survival

    Progression free survival (PFS) is defined as the time from registration to the first occurrence of progression or relapse as assessed by the investigator, or death from any cause. PFS for patients without disease progression, relapse, or death will be censored at the time of the last tumor assessment.

    Measured: [Time Frame: From date of signing the informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years]

  8. 2 years overall survival

    Overall survival is defined as the period from the induction registration to death from any cause. Patients who have not died until the time of the analysis will be censored at their last contact date.

    Measured: [Time Frame: From date of signing the informed consent until the date of death from any cause, whichever came first, assessed up to 2 years]

  9. The occurrence of adverse events

    Adverse events will be graded by the investigator according to the NCI-CTCAE Version 5.0.

    Measured: One month after discontinuation of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2024
  2. Study start25 Aug 2024 (estimated)
  3. Primary completion10 Aug 2026 (estimated)
  4. Study completion10 Aug 2028 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
51 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06566807
Sponsor's protocol ID
KY-2024-180-01
Status last verified
Aug 2024
First submitted
14 Aug 2024
Last updated
22 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sharp J, Shana'ah AY, Voorhees TJ, Bond DA, Sawalha Y, Sigmund A, Hanel W, Sehgal L, Alinari L, Baiocchi R, Maddocks K, Jones D, Christian B, Epperla N. Resistance Mechanism for Zanubrutinib in Marginal Zone Lymphoma. J Natl Compr Canc Netw. 2025 Jun 23;23(7):e257045. doi: 10.6004/jnccn.2025.7045.

    PubMed 40550489

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Orelabrutinib, obinutuzumab in people with Marginal Zone Lymphoma, run by Huai'an First People's Hospital 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 8 inclusion and 9 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 22 Aug 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 Chunling Wang (15189552696, wcl6506@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (ORR) (time frame: At the end of Cycle 6 (each cycle is 28 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06566807, which also lists 1 linked publication.

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 22 Aug 2024.

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