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Marginal Zone LymphomaPhase 2NCT06454968

Orelabrutinib Combined With Obinutuzumab and Lenalidomide (OGL Regimen) as First-line Treatment for Marginal Zone Lymphoma.

A Phase 2 study testing Orelabrutinib, obinutuzumab, lenalidomide in people with Marginal Zone Lymphoma, run by Peking Union Medical College 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 multicenter prospective single arm phase II study, and the purpose of this study is to evaluate the safety and efficacy of orelabrutinib combined with obinutuzumab and lenalidomide in untreated marginal zone lymphoma. The primary objective was the best complete response rate (CRR). 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, lenalidomide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteChina
Study dates
20 Jun 2024to 1 Jun 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, either sex.
  • Histopathologically confirmed B-cell non-Hodgkin lymphoma MZL (splenic, nodal, or extra-nodal).
  • At least 1 measurable lesion
  • Eligible for treatment: meets the GELF criteria, or has clinical symptoms/organ dysfunction related to the disease
  • Patients who are not suitable for local radiotherapy or whose condition progresses after local treatment, and those not suitable for local radiotherapy include the following situations:
  • Ann Arbor non-continuous Stage II or Stage III-IV non-gastric MALT and nodal MZL
Show all 11Show fewer
  • SMZL (Splenic Marginal Zone Lymphoma)
  • Gastric MALT with Lugano Stage II2/IIE/IV
  • ECOG performance status (PS) score of 0-2.
  • Expected survival time is ≥3 months
  • Sign the Informed consent

Who cannot join

  • Currently has other malignant tumors;
  • Lymphoma involving the central nervous system
  • Allergic to any of the study drugs;
  • Active infection or uncontrolled HBV infection (DNA\>105/ml), HIV/AIDS, or other severe infectious diseases;
  • Pregnant or lactating women and women of childbearing age who are unwilling to use contraception;
  • Any other conditions deemed unsuitable for participation in this trial by the investigator.

Trial locations and contacts

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

Jiayue Li contact

+86 1069156874

pumchkyc@126.com

China1 site, 1 recruiting

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

    wei Wang, +86 13810131294, wangweipumc@163.com

    Recruiting

Other trials in China

About this study

Official title: Orelabrutinib Combined With Obinutuzumab and Lenalidomide (OGL Regimen) as First-line Treatment for Marginal Zone Lymphoma：a Multicenter Prospective Single Arm Trial

This is a multicenter prospective single arm phase II study, and the purpose of this study is to evaluate the safety and efficacy of orelabrutinib combined with obinutuzumab and lenalidomide in untreated marginal zone lymphoma. The primary objective was the best complete response rate (CRR).

Read the detailed description

Marginal zone lymphomas (MZL) are a type of lymphoma that originates from the marginal zone tissue of the lymphoid follicles (Mucosa-associated lymphoid tissue, MALT), and include three subtypes: MALT lymphoma, nodal MZL, and splenic MZL. The incidence of MZL is second only to diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL), accounting for approximately 7.8% of all non-Hodgkin lymphomas (NHL). MZL is considered an indolent lymphoma, with patients generally having a better overall survival prognosis. Despite this, some patients still face the challenges of disease relapse or transformation into large cell lymphoma, leading to a poor prognosis.

We conduct this prospective, phase II, single-arm clinical study to initially explore the efficacy and safety of Orelabrutinib combined with obinutuzumab and lenalidomide in patients with previously untreated marginal zone lymphoma. The patients will be treated with 6 cycles of OGL regimen. Patients with CR/PR after 6 cycles of OGL treatment will be treated with 6 cycles of single-agent orelabrutinib regimen.

Being tested
Orelabrutinib, obinutuzumab, lenalidomide
Keywords
Orelabrutinib, Marginal Zone Lymphoma, obinutuzumab, lenalidomide
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, obinutuzumab, lenalidomideDrug

    Orelabrutinib: 150mg qd d1-d21/C1-C6 obinutuzumab: 1000mg iv d1,d8,d15/c1, 1000mg iv d1/C2-C6 lenalidomide：25mg po qd d1-14/C1-C6 Orelabrutinib: 150mg qd d1-d28/C7-C12

Study groups in NCT06454968
Study groupRoleWhat they receive
OGLExperimentalOrelabrutinib: 150mg qd d1-d21/C1-C6 obinutuzumab: 1000mg iv d1,d8,d15/c1, 1000mg iv d1/C2-C6 lenalidomide：25mg po qd d1-14/C1-C6 Orelabrutinib: 150mg qd d1-d28/C7-C12
Receives: Drug: Orelabrutinib, obinutuzumab, lenalidomide

What is being measured

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

  1. the best complete response rate

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

    Measured: At the end of cycle 12(the first 6 cycles are 21 days each, and the following 6 cycles are 28 days each)

Secondary outcomes (8)

  1. ORR

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

    Measured: At the end of therapy(up to 42 weeks)

  2. CRR

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

    Measured: At the end of therapy(up to 42 weeks)

  3. The best ORR

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

    Measured: At the end of cycle 12(the first 6 cycles are 21 days each, and the following 6 cycles are 28 days each)

  4. 2 years progression-free survival Progression free survival (PFS)

    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: 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]

  5. 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: From date of signing the informed consent until the date of death from any cause, whichever came first, assessed up to 2 years]

  6. TTR

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

    Measured: Up to 2 years

  7. 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. Patients alive without progression and relapse will be censored at the latest tumor assessment date or the stopping date.

    Measured: Up to 2 years

  8. The occurrence of adverse events and serious adverse events

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

    Measured: One month after the end of treatment（up to 46 weeks）

Timeline

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

  1. First posted12 Jun 2024
  2. Study start20 Jun 2024 (estimated)
  3. Primary completion1 Jun 2026 (estimated)
  4. Study completion1 Jun 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
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06454968
Sponsor's protocol ID
PUMCH-NHL-017
Status last verified
May 2024
First submitted
27 May 2024
Last updated
18 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
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, lenalidomide in people with Marginal Zone Lymphoma, run by Peking Union Medical College 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 11 inclusion and 6 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 18 Jun 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 Jiayue Li (+86 1069156874, pumchkyc@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the best complete response rate (time frame: At the end of cycle 12(the first 6 cycles are 21 days each, and the following 6 cycles are 28 days each)). 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 NCT06454968, 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 18 Jun 2024.

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