Pediatric Classical Hodgkin Lymphoma Study: cHOD17

Sponsor: St. Jude Children's Research Hospital

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT03755804

Provider View

This study is testing different chemotherapy treatments based on risk levels for children and young adults with classical Hodgkin lymphoma. It aims to find the best treatment approach for low, intermediate, and high-risk patients.

Patient Parameters

Program Overview

This study is designed to test different chemotherapy treatments for children and young adults with classical Hodgkin lymphoma, based on their risk level. Low and intermediate-risk patients will receive a combination of chemotherapy drugs known as BEABOVP, while high-risk patients will receive a different combination called AEPA and CAPDac. Radiation therapy will be added if needed, based on how well the cancer responds after two cycles of chemotherapy.

Description

The main goals of this study are to see how well the BEABOVP chemotherapy works for low and intermediate-risk patients and to measure the event-free survival for high-risk patients. Researchers will also look at the side effects of the treatments, such as blood and nerve-related issues, and compare the results with past studies.

For low and intermediate-risk patients, the BEABOVP treatment includes several drugs given in cycles, with specific schedules for each drug. High-risk patients will receive AEPA and CAPDac treatments, which also involve multiple drugs given in cycles. Radiation therapy will be used if the cancer does not respond well after two cycles of chemotherapy.

The study will also explore various scientific aspects, such as how the drugs are processed in the body and how the immune system responds to the treatment. Participants will undergo various tests to monitor their health and the effects of the treatment.

Low-risk patients will receive 2 cycles of BEABOVP, while intermediate-risk patients will receive 3 cycles. High-risk patients will receive 2 cycles of AEPA and 4 cycles of CAPDac. Radiation therapy will be added if needed, based on the response after two cycles of chemotherapy.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with CD30+ classical Hodgkin lymphoma and have not received prior treatment, except for limited emergency radiation or steroids.
  • Age 21 or younger for low and intermediate-risk patients, and 25 or younger for high-risk patients.
  • All stages of Hodgkin lymphoma are eligible, with specific criteria for low, intermediate, and high-risk groups.
  • Must have good kidney and liver function, as well as adequate blood cell counts.
  • Must have good heart and lung function, unless affected by the lymphoma.
  • Female participants who have started menstruating must have a negative pregnancy test.
  • Participants of reproductive age must agree to use effective birth control during the study.

Exclusion Criteria

  • Diagnosed with CD30 negative Hodgkin lymphoma.
  • Have received prior treatment for Hodgkin lymphoma.
  • Have inadequate organ function.
  • High-risk patients with significant nerve damage or active neurological disease.
  • Unable or unwilling to provide informed consent.

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