NCT06592170 Linperlisib Combination With Obinutuzumab Frontline Treatment of Marginal Zone Lymphoma Patients (MZL)
| NCT ID | NCT06592170 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | The First Hospital of Jilin University |
| Condition | Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 35 participants |
| Start Date | 2024-08-13 |
| Primary Completion | 2025-08-13 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
This is a single arm, open label, national multicenter clinical study included patients with marginal zone lymphoma patients (MZL) , aim is to evaluate the efficacy and safety of first-line treatment with Linperlisib combined with obinutuzumab in patients with marginal zone lymphoma (MZL).
Eligibility Criteria
Inclusion Criteria: * 1\. Age ≥ 18 years old, both male and female are acceptable; 2. Newly diagnosed marginal zone lymphoma confirmed by histopathology. Including extranodal MZL, intranodal MZL, and splenic MZL; 3. There is at least one measurable lesion: the longest diameter (LDi) of a lymph node lesion is greater than 1.5 cm or the LDi of an extra lymph node lesion is greater than 1 cm (according to the 2014 Lugano classification); 4. The physical status score of the Eastern Cooperative Oncology Group (ECOG) is ≤ 2; 5. Expected lifespan ≥ 12 weeks; 6. Have not received any previous anti-tumor treatment; 7. Possess sufficient bone marrow and organ functions; 8. All screening laboratory tests must be conducted according to the protocol requirements, and must be conducted within 7 days prior to enrollment. The values of laboratory tests conducted for screening must meet the following standards: Blood routine examination (no blood transfusion within 14 days before screening, no use of g