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

NCT06832228 | Recruiting

• 1 other identifier: PPR
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Complete Remission Rate（CRR）

  28days after the end of treatment

• Disease-control Rate（DCR）

  28days after the end of treatment

• Progression-Free Survival（PFS）

  Up to 2 years

• overall survival（OS）

  Up to 2 years

• Adverse event rate

  From date of first day of treatment until 30 day after last treatment

Study Arms (1)

pomalidomide combination with rituximab and Anti-PD-1 Antibody

EXPERIMENTAL

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）

Interventions

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

pomalidomide combination with rituximab and Anti-PD-1 Antibody

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

Rituximab

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Haiyan Yang, PhD

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haifeng Yu, MD

CONTACT

15157155533; yuhaifeng5533@dingtalk.com

Haiyan Yang, PhD

CONTACT

0571-88122192; yanghy@zjcc.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: February 18, 2025
• Study Start: September 1, 2024
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 18, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)