Combining Pomalidomide, Rituximab, and Anti-PD-1 for DLBCL Treatment
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 is testing a new combination of three medications to see if it can help people with hard-to-treat diffuse large B-cell lymphoma feel better when other treatments haven't worked.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Zhejiang Cancer Hospital Academic / other |
| Drugs / interventions | rituximab |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06832228 on ClinicalTrials.gov |
What this trial studies
This study explores the effectiveness and safety of a combination therapy using pomalidomide, rituximab, and an anti-PD-1 antibody for patients with diffuse large B-cell lymphoma (DLBCL) who have not responded to previous treatments. It targets individuals in the third or later line of therapy, aiming to provide a new treatment option for those with relapsed or refractory disease. The study will assess patient outcomes and monitor for any adverse effects associated with this combination therapy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with histopathologically confirmed DLBCL who have not achieved complete remission after second-line therapy.
Not a fit: Patients with primary central nervous system DLBCL or primary mediastinal large B-cell lymphoma will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with advanced DLBCL who have limited alternatives.
How similar studies have performed: While this specific combination has not been widely tested, similar approaches using immunotherapy and targeted agents have shown promise in treating DLBCL.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Hangzhou, Zhejiang
- Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: Haiyan Yang, PhD — Zhejiang Cancer Hospital
- Study coordinator: Haifeng Yu, MD
- Email: yuhaifeng5533@dingtalk.com
- Phone: 15157155533
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.