Study on Brentuximab Vedotin, Rituximab, and Modified CHP for Elderly Patients with Diffuse Large B-Cell Lymphoma (DLBCL)

Sponsor: Patrick Reagan

Sponsor score: 0

ClinicalTrials ID:NCT02734771

Provider View

This clinical trial is testing a new treatment combination for elderly patients with Diffuse Large B-Cell Lymphoma (DLBCL). The study aims to see if adding brentuximab vedotin to a modified chemotherapy regimen can be effective and safe.

Patient Parameters

Program Overview

The study is exploring a new treatment approach for elderly patients with Diffuse Large B-Cell Lymphoma (DLBCL). It combines brentuximab vedotin with a modified version of the standard chemotherapy regimen, which includes rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP). Vincristine, a drug usually part of the standard treatment, is not included due to potential overlapping side effects with brentuximab vedotin. Patients will be grouped based on whether their cancer cells have a specific marker called CD30. A comprehensive assessment of each patient's health will be conducted, but it won't affect treatment decisions.

Description

This study is being conducted at multiple centers and involves a single group of participants. It aims to test a new treatment combination for elderly patients with Diffuse Large B-Cell Lymphoma (DLBCL). The treatment includes brentuximab vedotin and a modified chemotherapy regimen (R-CHP), which excludes vincristine to avoid overlapping side effects. Patients will be divided into two groups based on the presence of a marker called CD30 on their cancer cells. A comprehensive health assessment will be performed for all participants, but it will not influence the treatment plan. The study seeks to determine the safety and effectiveness of this new treatment approach.

Eligibility Criteria

Inclusion Criteria

  • Must provide written consent to participate and understand they can withdraw at any time.
  • Men and women aged 75 years or older.
  • Have a performance status score of 0 to 3, indicating varying levels of activity.
  • Have a confirmed diagnosis of DLBCL, including certain transformed or composite types.
  • Have not received prior treatment for DLBCL, except for a short course of prednisone.
  • If previously treated for follicular lymphoma, must not have received anthracycline-based therapy.
  • Hepatitis B carriers must be monitored for signs of active infection.
  • Liver function tests must be within specified limits, with some allowances for liver involvement by DLBCL.

Exclusion Criteria

  • Low platelet count (≤50,000/mm3) or low neutrophil count (<1,000/mm3) within 14 days before joining the study.
  • Poor kidney function (creatinine clearance <30 mL/minute) or on dialysis.
  • Significant nerve damage (Grade 2 or higher) within 14 days before joining the study.
  • Serious medical or psychiatric conditions that could interfere with the study.
  • Severe heart failure or low heart function.
  • Recent use of other investigational drugs.
  • Previous treatment with anthracyclines.
  • Active cancer that could interfere with study outcomes, except for certain skin cancers or early-stage cancers treated with surgery.
  • Known HIV positive status.
  • History of organ or stem cell transplantation.
  • History of central nervous system lymphoma.
  • Significant abnormalities in blood tests that could affect study participation.

Locations

FACILITYZIPCITYSTATE
James P. Wilmot Cancer Institute, University of Rochester Medical Center14642RochesterNew York
University of Virginia Cancer Center22908CharlottesvilleVirginia

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