Polatuzumab, Rituximab and Orelabrutinib Combination Regimen (PRO) in the Treatment of Elderly Frail Patients with Treatment-naive Non-GCB DLBCL

Affiliated Hospital of Nantong University

Status and phase: Enrolling; Phase 2

Conditions: Diffuse Large B Cell Lymphoma

Treatments: Drug: Rituximab; Drug: Polatuzumab vedotin; Drug: Orelabrutinib

Study type: Interventional

Funder types: Other

Identifiers

NCT06530511

JCLG-24-7

Details and patient eligibility

About

This prospective, single-arm, multicenter clinical study aims to enroll 30 frail elderly patients with Non-GCB DLBCL. This study is to evaluate the preliminary efficacy and safety of the combination of Polatuzumab, Rituximab, and orelabrutinib in this population. The primary endpoint is CR rate after induction therapy.

Enrollment: 30 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with histopathologically confirmed DLBCL;

  • The sGA evaluation result of octogenarians or 60-79 years old is unfit or f RA il;

    • Non-germinal center (Non-GCB) type;

      • ECOG performance status score of 0-3 points; ⑤ No previous treatment for Lymphoma (unless glucocorticoid); 6 Radiographic Investigation to measurable disease, defined as the longest diameter with at least one Lymph node disorder > 1.5 cm, or at least one extranodal lesion > 1.0 cm in the longest diameter; ⑦ Adequate organ function;

        • Life expectancy ≥ 12 weeks; ⑨ Signed written informed consent.

Exclusion criteria

• Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, Coagulopathy diseases, autoimmune diseases and severe Immunization diseases, etc.;

  • Laboratory abnormalities at screening (unless caused by Lymphoma) A) ANC < 1.5 x 109/L, PLT < 80 x 109/L b） Coagulation: INR greater than 1.5 x upper limit of normal; PT and APTT greater than 1.5 x upper limit of normal c） Liver function: ALT or AST 2 times higher than upper limit of normal, AKP and Bilirubin 1.5 times higher than upper limit of normal d） Renal function: Creatinine high 1.5 times the upper limit of normal, Creatinine clearance < 60 mL/min (estimated by C OC kcroft-Gault formula); ③ HIV Infection;

    • HbsAg positive patients should be HBV DNA negative before enrollment; in addition, if the patients are HBsAg negative but HBcAb positive (regardless of HBsAb status), HBV DNA detection is still required; if the results are positive, antiviral therapy is required, and HBV DNA negative before enrollment;

      • Requires continuous treatment with strong and moderate CYP3A inhibitors or CYP3A Induction agents. Patients who have taken strong and moderate CYP3A inhibitors or CYP3A Induction agents (or have taken these agents within 5 half-lives) within 7 days prior to the first dose of study drug should not be enrolled; ⑥ Inability to swallow capsules or suffering from diseases that seriously affect gastrointestinal function, such as Syndrome malabsorption, gastric or Small intestinal resection, symptomatic Inflammatory bowel disease or partial or complete Intestinal obstruction; ⑦ Other concurrent and uncontrolled medical conditions that, in the opinion of the investigators, would affect the patients' participation in the study, including patients with Psychosis or other patients known or suspected to be unable to fully comply with the study protocol.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

PRO

Experimental group

Description:

The drugs involved in this trial include Polatuzumab, Rituximab, and orelabrutinib in 21-day cycles. The dose and administration method of the study drug were as follows: * Polatuzumab: 1.8 mg/kg, IV, D1; * Rituximab: 375 mg/m2, IV, D1; * Orelabrutinib: 150 mg/time, qd, po, D1-21;

Treatment:

Drug: Orelabrutinib

Drug: Polatuzumab vedotin

Drug: Rituximab