Study on Brentuximab Vedotin with Chemotherapy for Children with Advanced Hodgkin Lymphoma

Sponsor: Takeda

Sponsor score: 60

ClinicalTrials ID:NCT02979522

Provider View

This clinical trial is testing a new treatment combining brentuximab vedotin with chemotherapy drugs to see if it is safe and effective for children with advanced stage Hodgkin Lymphoma that has just been diagnosed.

Patient Parameters

Program Overview

The aim of this study is to find out if a new treatment using brentuximab vedotin, combined with chemotherapy drugs doxorubicin, vinblastine, and dacarbazine, is safe and effective for children with advanced stage Hodgkin Lymphoma. Researchers want to determine the best dose and see how well the treatment works in shrinking tumors.

Description

This study is testing a drug called brentuximab vedotin to treat children with advanced stage Hodgkin Lymphoma that has just been diagnosed. The study will check if the drug is safe, how well it is tolerated, and how effective it is in combination with standard chemotherapy drugs.

The study will include about 55 children and will be conducted in two phases. In Phase 1, at least 6 children will receive the treatment to find the best dose. In Phase 2, more children will be treated with this dose to see how well it works. The treatment involves giving brentuximab vedotin at a dose of 48 mg/m² along with doxorubicin, vinblastine, and dacarbazine.

This study will take place in the United States, Italy, Brazil, and Japan. Participation will last about 55 months, including follow-up. After the last dose, children will be monitored for 30 days and then every 12 weeks for a year, and every 24 weeks for up to 2 years to check on their health and cancer status.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with classical Hodgkin Lymphoma that is CD30 positive.
  • Have advanced stage Hodgkin Lymphoma (Stage III or IV) that is newly diagnosed.
  • Have not received any treatment for Hodgkin Lymphoma before.
  • Have a performance score of 50 or higher, indicating they can perform daily activities.
  • Have measurable disease as shown by scans.
  • Have adequate blood counts and kidney and liver function.

Exclusion Criteria

  • Have a type of Hodgkin Lymphoma called nodular lymphocyte predominant.
  • Have active brain or spinal cord disease or a history of certain brain diseases.
  • Have nerve damage affecting movement or sensation.
  • Have serious nerve problems affecting daily life or needing medication.
  • Have an active infection needing antibiotics within 2 weeks before starting the study.
  • Have allergies to certain proteins or ingredients in the study drugs.
  • Have HIV or active hepatitis B or C infections.
  • Have had another cancer within the last 3 years, except for certain skin cancers or carcinoma in situ that have been completely removed.
  • Are taking certain medications that affect how the study drugs work.
  • Have serious heart conditions or poor heart function.

Locations

FACILITYZIPCITYSTATE
Children's Hospital Colorado80045AuroraColorado
Cincinnati Children's Hospital Medical Center45229CincinnatiOhio

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