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

NCT ID: NCT07072208

Last Updated: 2025-07-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2027-05-01

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).

Detailed Description

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 with a lesion reduction of ≥25% received Pro-pola(Pro regimen plus polatuzumab vedotin), in a 21-day cycle for 6 cycles.

Conditions

Diffuse Large B-Cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pro-pola regimen

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complete remission \[CR\], partial remission \[PR\], and mini response \[miniR; lesion reduction: 25.0%-50.0%\]) were withdrawn from the study.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.

Group Type: EXPERIMENTAL

Induction therapy-Pro regimen

Intervention Type: 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

Consolidation therapy-Pro-pola regimen

Intervention Type: 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

Interventions

Induction therapy-Pro regimen

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

Intervention Type: DRUG

Consolidation therapy-Pro-pola regimen

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age ≥70 years unfit or frail

2. There is at least one image-measurable lesion with a measurable lesion of at least 15 mm.

3. Histologically confirmed treatment-naive DLBCL.

4. Life expectancy is>3 months.

5. 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

6. 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.

7. Patients have the ability to understand and are willing to provide written informed consent.

8. 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.

Exclusion Criteria

1. Severe abnormal liver and kidney function (alanine aminotransferase, bilirubin, creatinine>3 times the upper limit of normal);

2. Presence of organic heart disease or severe arrhythmia leading to clinical symptoms or abnormal cardiac function (NYHA Functional Class Grade ≥2);

3. Uncontrolled active infection;

4. Co-existence of other tumors requiring treatment or intervention;

5. DLBCL involving central nervous system;

6. Current or expected need for systemic corticosteroid treatment;

7. Previous or current history of vascular embolism;

8. Other psychological conditions that prevent the patient from participating in the study or signing informed consent.

9. 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.

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Soochow University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhengming Jin

Role: STUDY_CHAIR

The First Affiliated Hospital of Soochow University

Changju Qu

Role: STUDY_DIRECTOR

The First Affiliated Hospital of Soochow University

Nana Ping

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Soochow University

Locations

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhengming Jin

Role: CONTACT

jinzhengming519519@163.com

67781856

Changju Qu

Role: CONTACT

qcj310@163.com

67781865

Facility Contacts

Zhengming Jin

Role: primary

jinzhengming519519@163.com

67781856

Changju Qu

Role: backup

qcj310@163.com

67781856

Other Identifiers

2024471

Identifier Type: -

Identifier Source: org_study_id