Pomalidomide, Rituximab and Orelabrutinib Combined With Polatuzumab Vedotin in the Treatment of Newly Diagnosed Elderly Patients With DLBCL

NCT07072208 | Recruiting

• 1 other identifier: 2024471
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy and safety of the Pro-Pola （Pomalidomide, rituximab, orelabrutinib and polatuzumab vedotin) regimen in elderly patients (aged ≥70 years) with newly diagnosed diffuse large B-cell lymphoma (DLBCL).

Conditions

Diffuse Large B-Cell Lymphoma

Keywords

Polatuzumab vedotin; pomalidomide; rituximab; Diffuse Large B-Cell Lymphoma; elderly patients; orelabrutinib

Outcome Measures

Primary Outcomes (1)

• Complete response rate(CRR)

  The rate of patients who achieved CR after 6 cycles of Pro-pola regimen

  At the end of 6 cycles of Pro-pola regimen (each cycle is 21 days)

Secondary Outcomes (4)

• Objective response rate(ORR)

  At the end of 6 cycles of Pro-pola regimen (each cycle is 21 days)

• 2-year progression-free survival(PFS)

  From the enrollment to 2-year after the treatment of last patient

• 2-year overall survival(OS)

  From the enrollment to 2-year after the treatment of last patient

• Main adverse reactions

  From the enrollment to 1 months after 6 cycles of Pro-pola regimen of the last patient (each cycle is 21 days)

Study Arms (1)

Pro-pola regimen

EXPERIMENTAL

The study will start with an initial 21-days of induction therapy with Pro regimen (Pomalidomide, rituximab and orelabrutinib)，following imaging examinations to evaluate response rates. Patients not achieving mRR (defined as complete remission \[CR\], partial remission \[PR\], and mini response \[miniR; lesion reduction: 25.0%-50.0%\]) were withdrawn from the study. Patients achieving mRR (with a lesion reduction of ≥25%) received Pro-pola(Pro regimen plus polatuzumab vedotin), in a 21-day cycle for 6 cycles.

Drug: Induction therapy-Pro regimen; Drug: Consolidation therapy-Pro-pola regimen

Interventions

Induction therapy-Pro regimen DRUG

Pro regimen induction(21days per cycle\*1 cycle) * Pomalidomide 4mg per tablet 4mg orally from Days 1 to 7 of each cycle * Rituximab 100mg per vial 375mg/m2, intravenous drip, Day 1 of each cycle * Orelabrutinib 50mg per tablet 150mg orally per day from Days 1 to 21 of each cycle

Pro-pola regimen

Consolidation therapy-Pro-pola regimen DRUG

Pro-pola regimen consolidation(21days per cycle\*6 cycle) -Pomalidomide 4mg per tablet 4mg orally from Days 1 to 7 of each cycle -Rituximab 100mg per vial 375mg/m2, intravenous drip, Day 1 of each cycle -Orelabrutinib 50mg per tablet 150mg orally per day from Days 1 to 21 of each cycle -Polatuzumab vedotin 30mg per vial 1.8 mg/kg, intravenous drip, Day 1 of each cycle

Pro-pola regimen

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥70 years unfit or frail
• There is at least one image-measurable lesion with a measurable lesion of at least 15 mm.
• Histologically confirmed treatment-naive DLBCL.
• Life expectancy is\>3 months.
• appropriate organ function: Cardiac function: Cardiac ejection fraction ≥50%; Liver function: alanine aminotransferase and aspartate aminotransferase ≤3 times the upper limit of normal; Renal function: Serum creatinine clearance ≥30mL/min; Lung function: SPO2 \>90% without oxygen inhalation
• Adequate bone marrow reserve is defined as:
• Hemoglobin ≥8g/dL, platelet count ≥75×10\^9/L, Absolute neutrophil value ≥1.0×10\^9/L, If accompanied by bone marrow invasion, platelet count ≥50×10\^9/L, absolute neutrophil count ≥0.75×10\^9/L.
• Patients have the ability to understand and are willing to provide written informed consent.
• Subjects with childbearing or childbearing potential must be willing to practice birth control from the date of registration in this study to the follow-up period of the study.

You may not qualify if:

• Severe abnormal liver and kidney function (alanine aminotransferase, bilirubin, creatinine\>3 times the upper limit of normal);
• Presence of organic heart disease or severe arrhythmia leading to clinical symptoms or abnormal cardiac function (NYHA Functional Class Grade ≥2);
• Uncontrolled active infection;
• Co-existence of other tumors requiring treatment or intervention;
• DLBCL involving central nervous system;
• Current or expected need for systemic corticosteroid treatment;
• Previous or current history of vascular embolism;
• Other psychological conditions that prevent the patient from participating in the study or signing informed consent.
• In the investigator's judgment, it is unlikely that the subject will complete all protocol-required study visits or procedures, including follow-up visits, or will not meet the requirements for participation in the study.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

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

Study Officials

• Zhengming Jin

  The First Affiliated Hospital of Soochow University

  STUDY CHAIR

• Changju Qu

  The First Affiliated Hospital of Soochow University

  STUDY DIRECTOR

• Nana Ping

  The First Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhengming Jin

CONTACT

67781856; jinzhengming519519@163.com

Changju Qu

CONTACT

67781865; qcj310@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: July 18, 2025
• Study Start: November 1, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)