New treatment for relapsed or refractory diffuse large B-cell lymphoma
A Phase II Trial Evaluating the Efficacy of Polatuzumab Vedotin With Rituximab, Gemcitabine, Dexamethasone, and Cisplatin (PV-RGDP) Chemotherapy for Relapsed or Refractory Diffuse Large B-cell Lymphoma
This study is testing a new combination treatment for patients with diffuse large B-cell lymphoma that has come back or hasn’t responded to previous treatments, to see if it works better than standard options.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | UNC Lineberger Comprehensive Cancer Center Academic / other |
| Drugs / interventions | polatuzumab, rituximab |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT05498220 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a new treatment regimen combining polatuzumab vedotin with rituximab, gemcitabine, dexamethasone, and cisplatin for patients with diffuse large B-cell lymphoma that has relapsed or is refractory to previous treatments. The trial focuses on patients who have experienced their first relapse and includes both those eligible and ineligible for stem cell transplant. The goal is to improve response rates compared to standard salvage therapies, which have not been sufficient for many patients.
Who should consider this trial
Good fit: Ideal candidates are patients with biopsy-proven diffuse large B-cell lymphoma in their first relapse who have received only one prior line of therapy.
Not a fit: Patients with Burkitt's lymphoma or those who have had more than one prior line of therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective option for patients with relapsed or refractory diffuse large B-cell lymphoma.
How similar studies have performed: Other studies have shown promising results with similar antibody-drug conjugate approaches, indicating potential for success in this novel combination.
Eligibility criteria
Show full inclusion / exclusion criteria
In order to participate in this study, a subject must meet all of the eligibility criteria outlined below. Inclusion Criteria: 1. Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information. 2. Biopsy proven diffuse large B-cell lymphoma (DLBCL) in the first relapse (biopsy can be from initial diagnosis). The study will allow high-grade B cell lymphoma, but not including Burkitt's lymphoma. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2. 4. Radiologic evidence of active disease within 28 days of starting trial therapy. 5. Only one prior line of therapy. 6. Prior cancer treatment must be completed at least 14 days prior to the start of treatment and the subject must have recovered from all reversible acute toxic effects of the regimen (other than alopecia) to ≤ Grade 1 or start of treatment. 7. Subjects may be eligible or ineligible for autologous stem cell transplant Exclusion Criteria: 1. Known severe, active bacterial, viral, fungal, mycobacterial, parasitic, or other infections at study enrollment that may put the subject at undue risk as determined by the investigator. 2. Subjective hearing loss interfering with daily activities or evidence of greater than mild hearing loss compared to age appropriate normal on screening audiometry are excluded. 3. Women who are pregnant or breastfeeding or who intend to become pregnant within a year of the last dose of study treatment. 4. Subjects with a history of prior or concurrent second primary malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the study drugs are eligible for enrollment in the trial. 5. Previous exposure to polatuzumab vedotin. 6. History of severe allergic or anaphylactic reaction to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine. 7. Contraindication to gemcitabine or cisplatin, or dexamethasone or similar corticosteroid. 8. Symptomatic cardiac disease including ventricular dysfunction, left ventricular ejection fraction \< 40%, symptomatic coronary artery disease or symptomatic arrhythmias. 9. Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygenation \> 91% on room air.
Where this trial is running
Chapel Hill, North Carolina
- Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Christopher Dittus, DO, MPH — Division of Hematology | Lymphoma Program Lineberger Comprehensive Cancer Center
- Study coordinator: Leah Randolph
- Email: Leah_Randolph@med.unc.edu
- Phone: 919-966-4432
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.