Study on Brentuximab Vedotin for Early Stage Hodgkin Lymphoma

Sponsor: University College, London

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04685616

Provider View

This clinical trial is testing two different chemotherapy treatments for early stage Hodgkin Lymphoma to see which is more effective. Patients will receive either ABVD or A2VD chemotherapy, and their treatment will be adjusted based on PET-CT scan results.

Patient Parameters

Program Overview

The RADAR study is an international clinical trial testing two chemotherapy treatments for early stage Hodgkin Lymphoma. Patients will be randomly assigned to receive either ABVD or A2VD chemotherapy. After two cycles of treatment, a PET-CT scan will help determine the next steps in their treatment. Patients will be monitored for at least five years after completing treatment to track their progress.

Description

In this study, patients with early stage Hodgkin Lymphoma will receive one of two chemotherapy treatments: ABVD (which includes doxorubicin, bleomycin, vinblastine, and dacarbazine) or A2VD (which includes doxorubicin, brentuximab vedotin, vinblastine, and dacarbazine, with growth factor support). After two cycles of treatment, all patients will have a PET-CT scan to assess their response to the treatment.

Based on the scan results, patients will continue with their assigned chemotherapy as follows:

  • If the scan shows a Deauville score of 1-3, patients will have one more cycle of chemotherapy and then enter follow-up.
  • If the scan shows a Deauville score of 4, patients will have two more cycles of chemotherapy followed by targeted radiotherapy.
  • If the scan shows a Deauville score of 5, patients will stop the trial treatment and receive further care as decided by their doctor.

Patients with a Deauville score of 4 will have a final PET-CT scan to confirm their response to treatment. All participants will be followed for at least five years after treatment to monitor their health and any long-term effects.

Eligibility Criteria

Inclusion Criteria

  • Men and women aged 16-69 years (18-69 in the US and EU)
  • Confirmed diagnosis of classical Hodgkin Lymphoma
  • Stage I or II disease above the diaphragm without large tumors in the chest
  • No previous treatment for Hodgkin Lymphoma
  • Good overall health and able to receive chemotherapy
  • Adequate kidney, liver, and bone marrow function
  • Willing to follow study requirements, including contraceptive advice if applicable
  • Able to provide written informed consent

Exclusion Criteria

  • Previous treatment for Hodgkin Lymphoma, except short courses of steroids
  • Disease below the diaphragm
  • Specific types of Hodgkin Lymphoma not included in the study
  • No detectable cancer on initial PET scan
  • Age 70 or older, or 15 or younger
  • Other cancers diagnosed in the last 5 years, except certain skin cancers
  • Pre-existing nerve damage or brain conditions
  • Active infections like HIV, hepatitis B or C
  • Recent use of other investigational drugs
  • Pregnant or breastfeeding women
  • Allergies to study drugs or their components
  • Significant heart or lung conditions that prevent chemotherapy use
  • Other serious medical or psychiatric conditions that make the study treatment unsafe

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