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

Not Applicable

Recruiting

• Conditions: Diffuse Large B-cell Lymphoma (DLBCL)
• Interventions: Drug: Pomalidomide Combination With Rituximab and Anti-PD-1 Antibody （PPR）

• Registration Number: NCT06832228
• Lead Sponsor: Zhejiang Cancer Hospital

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)

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study Start: 2024-09-01
• Study First Submitted: 2025-02-12
• Study First Submitted QC: 2025-02-12
• Last Update Submitted: 2025-02-12
• Study First Posted: 2025-02-18
• Last Update Posted: 2025-02-18
• Primary Completion: 2025-09-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
pomalidomide combination with rituximab and Anti-PD-1 Antibody	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. Patients who achieved PR or CR after 6 cycles were treated with maintenance therapy at the investigator's discretion (1-2 years).

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China