Clinical trial · Interventional
Orelabrutinib Combined With Obinutuzumab and Lenalidomide (OGL Regimen) as First-line Treatment for Marginal Zone Lymphoma.
Orelabrutinib Combined With Obinutuzumab and Lenalidomide (OGL Regimen) as First-line Treatment for Marginal Zone Lymphoma：a Multicenter Prospective Single Arm Trial
NCT06454968CI-TRIAL-00078029recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Marginal Zone Lymphoma | Marginal Zone Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Orelabrutinib, obinutuzumab, lenalidomide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- OGL
- description
- 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
- interventionNames
- Drug: Orelabrutinib, obinutuzumab, lenalidomide
Primary outcomes (1)
- measure
- the best complete response rate
- timeFrame
- At the end of cycle 12(the first 6 cycles are 21 days each, and the following 6 cycles are 28 days each)
- description
- CRR is defined as the proportion of patients with a best response of CR
Secondary outcomes (8)
- measure
- ORR
- timeFrame
- At the end of therapy(up to 42 weeks)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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: * Ann Arbor non-continuous Stage II or Stage III-IV non-gastric MALT and nodal MZL * 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 Exclusion Criteria: * 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.
References
Publications (1)
- DERIVEDSharp 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. PMID 40550489