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

Prospective Single-center Study of Pomalidomide Combination with Rituximab and Anti-PD-1 Antibody （PPR） in Third or Later Line Therapy of Diffuse Large B-cell Lymphoma (DLBCL)

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)

Study Overview

• Status: Recruiting
• Conditions: Diffuse Large B-cell Lymphoma (DLBCL)
• Intervention / Treatment: Drug: Pomalidomide Combination With Rituximab and Anti-PD-1 Antibody （PPR）

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Haiyan Yang, PhD; Phone Number: 0571-88122192; Email: yanghy@zjcc.org.cn
• Study Contact Backup: Name: Haifeng Yu, MD; Phone Number: 15157155533; Email: yuhaifeng5533@dingtalk.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Recruiting
      • Zhejiang Cancer Hospital
      • Contact: Haiyan Yang, PhD; Phone Number: 0571-88122192; Email: yanghy@zjcc.org.cn
      • Contact: Haifeng Yu, MD; Phone Number: 15157155533; Email: yuhaifeng5533@dingtalk.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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).

Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Response Rate (ORR)	The proportion of subjects who achieves a best overall response of CR or PR.	28days after the end of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival（PFS）	From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first	Up to 2 years
Adverse event rate	The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).	From date of first day of treatment until 30 day after last treatment
Complete Remission Rate（CRR）	The proportion of subjects who achieves a best overall response of CR.	28days after the end of treatment
Disease-control Rate（DCR）	The proportion of subjects response of CR, PR, or SD	28days after the end of treatment
overall survival（OS）	The overall survival time refers to the time from therapy to death due to any cause.	Up to 2 years

Collaborators and Investigators

• Sponsor: Zhejiang Cancer Hospital
• Investigators: Principal Investigator: Haiyan Yang, PhD, Zhejiang Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: February 12, 2025
• First Submitted That Met QC Criteria: February 12, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 12, 2025
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse; Antineoplastic Agents, Immunological; Antineoplastic Agents; Immunologic Factors; Physiological Effects of Drugs; Antirheumatic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Rituximab; Antibodies; Pomalidomide
• Other Study ID Numbers: PPR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No