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

NCT06530511 | Recruiting Phase 2

• 1 other identifier: JCLG-24-7
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Diffuse Large B Cell Lymphoma

Keywords

elderly; frail; PRO; Non-GCB; DLBCL

Outcome Measures

Primary Outcomes (1)

• CRR

  Complete response rate (CRR) at the end of Induction treatment (6 cycles)

  6 months

Secondary Outcomes (5)

• ORR

  6 months

• 2y-PFS rate

  24 months

• OS

  24 months

• EFS

  24 months

• Safety profile

  24 months

Other Outcomes (1)

• Potential predictive factors

  24 months

Study Arms (1)

PRO

EXPERIMENTAL

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;

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

Interventions

Polatuzumab vedotin DRUG

Polatuzumab: 1.8 mg/kg, IV Drip infusion, D1;

PRO

Rituximab DRUG

Rituximab: 375 mg/m2, IV Drip infusion, D1

PRO

Orelabrutinib DRUG

Orelabrutinib: 150 mg/time, qd, po, D1-21

PRO

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Affiliated Hospital of Nantong University: lead

Study Sites (2)

Affiliated hospital of Nantong University

Nantong, Jiangsu, 226005, China

RECRUITING

Jiangsu Province Hospital

Nanjing, China

NOT YET RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

polatuzumab vedotin; Rituximab; orelabrutinib

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Wenyu Shi

CONTACT

+86 13515203737; shiwenyu@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Oncology

Study Record Dates

• First Submitted: July 23, 2024
• First Posted: July 31, 2024
• Study Start: August 1, 2024
• Primary Completion: February 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 4, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: starting 6 months after publication
• Access Criteria: IPD could be shared by contacting the corresponding author via email after publication

Locations

CN (2)