Split-Dose R-CHOP Chemotherapy for Older Adults with Diffuse Large B-Cell Lymphoma (DLBCL)

Sponsor: University of Wisconsin, Madison

Sponsor score: 0

ClinicalTrials ID:NCT03943901

Provider View

This study is exploring a new way to give R-CHOP chemotherapy to older adults with Diffuse Large B-Cell Lymphoma (DLBCL). It focuses on patients aged 75 and older, and some aged 70-74, who are often not included in clinical trials. The study lasts for 2.5 years, including 6 months of treatment and 2 years of follow-up.

Patient Parameters

Program Overview

The study aims to test a new schedule for giving R-CHOP chemotherapy to older adults with newly diagnosed DLBCL. This involves splitting the doses of certain chemotherapy drugs and giving them every 14 days, with Rituximab given once a month. The goal is to see if this method is safe and effective for older patients, allowing them to receive treatment that aims to cure the cancer.

Description

In this study, older adults with a new diagnosis of DLBCL will receive a modified version of R-CHOP chemotherapy. This involves giving half doses of the chemotherapy drugs Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone every 14 days, with a full dose of Rituximab once a month, for up to 6 months. If patients show no signs of cancer after 2 months, they may receive a shorter course of treatment. The study hopes to show that this approach is safe and effective for older patients, allowing them to receive treatment with the intent to cure their cancer.

Eligibility Criteria

Inclusion Criteria

  • Must sign a consent form to participate.
  • Aged 75 or older, or aged 70-74 if considered frail based on a specific health assessment.
  • Newly diagnosed with untreated DLBCL, confirmed by a biopsy.
  • Must have measurable disease by scans or bone marrow biopsy.
  • Heart function must be adequate, with a specific test showing at least 50% function.
  • Must be able to perform daily activities with some assistance.
  • Must have a life expectancy of more than 3 months.
  • Must test negative for HIV.
  • If positive for hepatitis B or C, must have a negative viral load and follow a treatment plan during chemotherapy.
  • May receive additional chemotherapy to prevent cancer spread to the brain, if recommended by the doctor.

Exclusion Criteria

  • Previous treatment with certain chemotherapy drugs.
  • Cancer spread to the brain or spinal cord.
  • Poor kidney function.
  • Poor liver function unless related to lymphoma.
  • Severe lung problems requiring oxygen.
  • Recent heart attack.
  • Active, uncontrolled infections.
  • Other active cancers or blood disorders.
  • Recent treatment with experimental drugs.
  • Unable or unwilling to sign consent.

Locations

FACILITYZIPCITYSTATE
University of Wisconsin Carbone Cancer Center53705MadisonWisconsin

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