Study on Polatuzumab Vedotin, Rituximab, and Reduced Dose CHP in Older Patients with DLBCL

Sponsor: University of Rochester

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04594798

Provider View

This clinical trial is testing the safety and effectiveness of a new treatment combination for patients aged 75 and older with Diffuse Large B-Cell Lymphoma (DLBCL). The treatment includes polatuzumab vedotin, rituximab, and a reduced dose of chemotherapy drugs.

Patient Parameters

Program Overview

The purpose of this study is to see if adding polatuzumab vedotin to a treatment plan that includes rituximab and a reduced dose of chemotherapy drugs (R-miniCHP) is safe and effective for patients aged 75 and older with Diffuse Large B-Cell Lymphoma (DLBCL).

Description

In this study, researchers want to understand how well polatuzumab vedotin works when added to a treatment plan with rituximab and a reduced dose of chemotherapy drugs (R-miniCHP) in patients aged 75 and older. The study will look at the safety and effectiveness of this combination in treating DLBCL, a type of aggressive lymphoma. Participants will receive the treatment and be monitored for any side effects and how well the cancer responds.

Eligibility Criteria

Inclusion Criteria

  • Must be 75 years or older.
  • Must have a confirmed diagnosis of DLBCL or related types of lymphoma.
  • Must not have received prior treatment for aggressive B-cell lymphoma, except for certain allowed medications.
  • Must not be a candidate for standard dose R-CHOP due to age or other health conditions.
  • Must have a heart function of at least 45%.
  • Must have adequate blood cell counts and organ function.
  • Men must agree to use contraception during treatment and for 5 months after.

Exclusion Criteria

  • History of lymphoma affecting the brain or spinal cord.
  • Specific types of lymphoma like primary mediastinal B-cell lymphoma.
  • Currently on dialysis.
  • Severe nerve damage.
  • Severe heart failure or low heart function.
  • Recent use of other experimental drugs.
  • Previous treatment with anthracycline, except for one urgent cycle.
  • Other active cancers that may interfere with the study.
  • Known HIV positive status.
  • Active hepatitis B infection.
  • History of organ or stem cell transplant.
  • Serious medical or psychiatric conditions that may affect participation.

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