Study of Pomalidomide Combination with Rituximab and Anti-PD-1 Antibody （PPR） in Third or Later Line Therapy of DLBCL

NCT ID: NCT06832228

Last Updated: 2025-02-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2026-09-01

Brief Summary

This study aims to observe and explore the efficacy and safety of pomalidomide combination with rituximab and Anti-PD-1 Antibody in Third or Later Line Therapy of diffuse large B-cell lymphoma (DLBCL)

Conditions

Diffuse Large B-cell Lymphoma (DLBCL)

Study Design

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

Study Groups

pomalidomide combination with rituximab and Anti-PD-1 Antibody

All patients will receive the PPR regimen (a total of 4-6 cycles, 28 days for each cycle):

• pomalidomide: 4 mg, orally, once daily from Day 1 to Day 21.
• Rituximab: 375 mg/m², administered on Day 1.
• PD-1: 200 mg, administered on Days 1. Patients who achieved PR or CR after 6 cycles were treated with maintenance therapy at the investigator's discretion (1-2 years).

Group Type: EXPERIMENTAL

Pomalidomide Combination With Rituximab and Anti-PD-1 Antibody （PPR）

Intervention Type: DRUG

All patients will receive the PPR regimen (a total of 4-6 cycles, 28 days for each cycle):

• pomalidomide: 4 mg, orally, once daily from Day 1 to Day 21.
• Rituximab: 375 mg/m², administered on Day 1.
• PD-1: 200 mg, administered on Days 1.

Interventions

Pomalidomide Combination With Rituximab and Anti-PD-1 Antibody （PPR）

All patients will receive the PPR regimen (a total of 4-6 cycles, 28 days for each cycle):

• pomalidomide: 4 mg, orally, once daily from Day 1 to Day 21.
• Rituximab: 375 mg/m², administered on Day 1.
• PD-1: 200 mg, administered on Days 1.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients voluntarily joined the study, signed the informed consent, and had good compliance;
• Patients with 18 Years to 80 Years(at the time of signing the informed consent); Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score: 0-2;
• Patients with histopathologically confirmed diffuse large B-cell lymphoma with evaluable lesions who did not achieve CR or relapsed after second-line therapy
• Female patients of reproductive age should agree that birth control (such as intrauterine device, birth control pills, or condoms) must be used during the study period and for six months after completion; Having a negative serum pregnancy test within 7 days prior to study enrollment, and must be non-lactating; Male patients should agree to use contraception during the study period and for six months after the end of the study.

Exclusion Criteria

• Pathological subtypes: primary central nervous system DLBCL or primary mediastinal large B-cell lymphoma.
• Presence of severe or uncontrolled comorbid conditions including, but not limited to, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina, active peptic ulcer disease, or severe hemorrhagic disorders such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring transfusion or other medical interventions.
• A history of any active immune or autoimmune disease, or a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
• Any active infection requiring systemic antimicrobial therapy within 14 days before starting study treatment, including, but not limited to, bacterial, fungal, and viral infections.
• Current participation in other clinical studies, or initiation of study drugs administration less than 4 weeks after completion of previous clinical study treatment.
• Patients with concomitant diseases that, in the investigator's judgment, may seriously endanger patients' safety or may interfere with the completion of the study, or are deemed unsuitable for inclusion for other reasons.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yang haiyan

Chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Haiyan Yang, PhD

Role: PRINCIPAL_INVESTIGATOR

Zhejiang Cancer Hospital

Locations

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Haifeng Yu, MD

Role: CONTACT

yuhaifeng5533@dingtalk.com

15157155533

Haiyan Yang, PhD

Role: CONTACT

yanghy@zjcc.org.cn

0571-88122192

Facility Contacts

Haiyan Yang, PhD

Role: primary

yanghy@zjcc.org.cn

0571-88122192

Haifeng Yu, MD

Role: backup

yuhaifeng5533@dingtalk.com

15157155533

Other Identifiers

PPR

Identifier Type: -

Identifier Source: org_study_id