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IBI376 Plus Rituximab in Patients With Untreated Indolent Lymphoma.

NCT05073250 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-05-12

No results posted yet for this study

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.

Conditions

  • Inert Non Hodgkin's Lymphoma

Interventions

DRUG

IBI376

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.

BIOLOGICAL

Rituximab

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.

Sponsors & Collaborators

  • Chinese PLA General Hospital

    lead OTHER

Principal Investigators

  • Weidong Han, Ph.D · Biotherapeutic Department, Chinese PLA General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05073250 on ClinicalTrials.gov