Study on Polatuzumab Vedotin with R-GDP for Treating Relapsed or Hard-to-Treat Diffuse Large B-cell Lymphoma

Sponsor: UNC Lineberger Comprehensive Cancer Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05498220

Provider View

This clinical trial is testing a new treatment combination for patients with diffuse large B-cell lymphoma (DLBCL) that has returned or not improved after previous treatments. The study aims to see if adding polatuzumab vedotin to a standard therapy can improve outcomes.

Patient Parameters

Program Overview

The purpose of this study is to evaluate a new treatment combination for diffuse large B-cell lymphoma (DLBCL) that has either come back or not responded to previous treatments. The treatment includes polatuzumab vedotin, a new drug that targets cancer cells, combined with rituximab, gemcitabine, dexamethasone, and cisplatin (PV-RGDP). This combination is not yet approved by the FDA for this type of lymphoma. The study will include patients who are experiencing their first relapse and will consider both those who can and cannot undergo a stem cell transplant.

Eligibility Criteria

Inclusion Criteria

  • Must provide written consent to participate and allow access to personal health information.
  • Have a confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) that has returned after initial treatment.
  • Have a performance status score of 0 to 2, indicating full activity or some restriction in strenuous activities.
  • Show evidence of active disease on scans within 28 days before starting the trial.
  • Have only received one previous line of treatment.
  • Must have completed prior cancer treatment at least 14 days before starting the study and recovered from any side effects to a mild level.
  • Can be eligible or ineligible for a stem cell transplant.

Exclusion Criteria

  • Have severe or active infections that could pose a risk during the study.
  • Have significant hearing loss that affects daily life.
  • Are pregnant, breastfeeding, or planning to become pregnant within a year after the last treatment dose.
  • Have another type of cancer that could interfere with the study.
  • Have previously been treated with polatuzumab vedotin.
  • Have had severe allergic reactions to certain antibodies or have known allergies to similar treatments.
  • Cannot take gemcitabine, cisplatin, or dexamethasone due to contraindications.
  • Have serious heart conditions, such as heart failure or abnormal heart rhythms.
  • Must have adequate lung function, with mild or no breathing difficulties and good oxygen levels.

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