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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OGL | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orelabrutinib, obinutuzumab, lenalidomide | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| the best complete response rate | CRR is defined as the proportion of patients with a best response of CR | At the end of cycle 12(the first 6 cycles are 21 days each, and the following 6 cycles are 28 days each) |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | ORR is defined as the proportion of patients with a response of CR or PR | At the end of therapy(up to 42 weeks) |
| CRR | CRR is defined as the proportion of patients with a best response of CR |
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Inclusion Criteria:
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:
ECOG performance status (PS) score of 0-2.
Expected survival time is ≥3 months
Sign the Informed consent
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiayue Li | Contact | +86 1069156874 | pumchkyc@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100730 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40550489 | Derived | 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. |
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| ID | Term |
|---|---|
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C000729508 | orelabrutinib |
| C543332 | obinutuzumab |
| D000077269 | Lenalidomide |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
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| At the end of therapy(up to 42 weeks) |
| The best ORR | The best ORR is defined as the proportion of patients with a best response of CR or PR | At the end of cycle 12(the first 6 cycles are 21 days each, and the following 6 cycles are 28 days each) |
| 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. | 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] |
| 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. | From date of signing the informed consent until the date of death from any cause, whichever came first, assessed up to 2 years] |
| TTR | TTR is defined as the time from registration to the first response. | Up to 2 years |
| 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. | Up to 2 years |
| 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. | One month after the end of treatment（up to 46 weeks） |
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D009930 |
| Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |