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

Launched by ZHEJIANG CANCER HOSPITAL · Feb 12, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment approach for patients with diffuse large B-cell lymphoma (DLBCL), which is a type of blood cancer. The study is testing a combination of three medications: pomalidomide, rituximab, and an anti-PD-1 antibody. This trial aims to see how well this combination works and how safe it is for patients who have already received two or more therapies for their cancer.

To participate in this study, patients need to be between 18 and 80 years old and have been diagnosed with DLBCL that has not responded to previous treatments or has come back after treatment. Participants must also be in decent health overall, as determined by a rating scale used by doctors. Women must agree to use birth control during the study, and men should also use contraception. If you join the study, you will be closely monitored for any side effects and how well the treatment is working. It's important to know that certain health conditions might prevent someone from participating in the trial, so a thorough health review will be conducted.

Gender

ALL

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.