drugset / Trial / NCT05073250

IBI376 Plus Rituximab in Patients With Untreated Indolent Lymphoma.

NCT05073250

Phase 2 Unknown 40 enrolled Chinese PLA General Hospital
NaSingle-groupOpen-labelTreatment

Summary

Follicular lymphoma (FL) and marginal zone lymphoma (MZL) are the most common inert non Hodgkin's lymphoma (iNHL). The standard first-line treatment of advanced FL / MZL is based on rituximab. Whether combined with chemotherapy or not, iNHL can induce lasting remission, but most of it is usually incurable. Therefore, early treatment of advanced iNHL should focus on protecting the bone marrow function of patients. Although the first-line immunochemotherapy offer high efficacy but also high incidence of toxicity. Phosphatidylinositol 3-kinase (PI3K) pathway plays an important role in the occurrence and development of B-cell malignant tumors. Studies have shown that PI3K inhibitor alone has good antitumor effect and tolerance in patients with recurrent refractory iNHL. In addition, PI3K inhibitor combined with rituximab showed better prognosis compared with rituximab monotherapy in FL / MZL patients. Therefore, the chemo-free regime, PI3K inhibitor in combination with rituximab may explore a new avenue for FL and MZL patients.

Timeline

Start
2021-12-31
Primary completion
2023-12-31
Completion
2024-11-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Parsaclisib Small molecule 2.5 mg Oral
Subject Rituximab Monoclonal antibody 375 mg/m2 Intravenous