Combination 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
This study is testing a new combination of three medications to see if it can help people with untreated marginal zone lymphoma get better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Drugs / interventions | obinutuzumab, orelabrutinib |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06454968 on ClinicalTrials.gov |
What this trial studies
This multicenter, prospective, single-arm phase II study evaluates the safety and efficacy of a combination of orelabrutinib, obinutuzumab, and lenalidomide in patients with untreated marginal zone lymphoma. The study aims to determine the best complete response rate after administering six cycles of the OGL regimen. Patients who achieve a complete or partial response will continue treatment with orelabrutinib alone for an additional six cycles. The study focuses on a specific type of B-cell non-Hodgkin lymphoma that can be challenging to treat effectively.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histopathologically confirmed marginal zone lymphoma and measurable lesions.
Not a fit: Patients with other malignant tumors, central nervous system involvement, or severe allergies to the study drugs may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve response rates and outcomes for patients with marginal zone lymphoma.
How similar studies have performed: While there have been studies on individual components, this specific combination approach is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Beijing, Beijing Municipality
- Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Jiayue Li
- Email: pumchkyc@126.com
- Phone: +86 1069156874
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.