IBI376 Plus Rituximab in Patients With Untreated Indolent Lymphoma.

Sponsor
Chinese PLA General Hospital
Study ID
NCT05073250
Phase
PHASE2
Status
Unknown

Conditions

  • Inert Non Hodgkin's Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IBI376 — DRUG
    IBI376 is administered orally once daily at a dose of 20 mg for 8 weeks, followed by an oral dose of 2.5 mg once daily. Patients assessed as PR after 6 cycles of induction therapy will receive another 6 cycles of IBI376 at an oral dose of 2.5 mg once daily.
  • Rituximab — BIOLOGICAL
    Rituximab is administered at a dose of 375 mg/m\^2 intravenously in the first 4 weeks, once a week. Subsequently, rituximab will be dosed once every 4 weeks. Patients assessed as PR after 6 cycles of induction therapy will receive another 6 cycles of rituximab at a dose of 375 mg/m\^2 intravenously once every 4 weeks.

Study Details

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.

Key Dates

Start date
Dec 31, 2021
Status verified
May 2023
Primary completion
Dec 31, 2023
Completion
Nov 1, 2024

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental arm
    Enrolled patients will be administered IBI376 plus rituximab, induction therapy for 6 cycles (28-day cycle). Patients assessed as partial response (PR) after 6 cycles of induction therapy will receive another 6 cycles of IBI376 combined with rituximab induction therapy.

Primary Outcome Measure

Complete response (CR) rate [ Time Frame: Within 6 months of induction therapy completion ]

Central Contacts