Brentuximab Vedotin Plus AVD in Limited-stage Hodgkin Lymphoma

• Investigate clinical activity of Brentuximab w/AVD in cHL [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  Primary clinical endpoint is complete remission rate measured by PET/CT. Overall response rate, Failure-free survival and overall survival will also be assessed.
  
  

• Estimate clinical activity of Brentuximab after one cycle [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  Measured via PET/CT response
  
  
• Safety and Tolerability of Brentuximab [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  Measured by rate of adverse events and discontinuation of therapy due to toxicity.
  
  
• Correlation of serum soluble CD30 and/or TARC and clinical response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  To investigate whether elevated baseline serum soluble CD30 and/or the chemokine ligand 17/thymus activation-related chemokine (TARC) correlate with clinical response, PET-CT results or rate of relapse
  
  

Each treatment cycle is 28 days. You will receive brentuximab alone on Day 1 and 15 of the first cycle (lead-in cycle). After cycle 1, you will receive brentuximab combined with AVD on Day 1 and 15 for 4-6 cycles, depending on your response to therapy. Brentuximab and AVD will be given to you by intravenous infusion (IV).

The following test and procedures will be performed on Days 1 and 15 of each cycle:

• Review of any side effects you have experienced and all medications you are taking
• Performance Status
• Physical exam and vital signs
• Routine blood tests
• Questionnaire to evaluate symptoms of neuropathy
• Research blood sample to look at markers to see how your body is responding to study medication
• PET-CT scan prior to completing cycle 2 of combination brentuximab/AVD

After the final dose of the study drug: The following assessments will be performed within one month of your last dose of study medication:

• Review of any side effects you have experienced and all medications you are taking
• Performance Status
• Physical exam and vital signs
• Routine blood tests
• Questionnaire to evaluate symptoms of neuropathy
• Research blood sample to look at markers to see how your body is responding to study medication
• PET-CT scan Follow up will include the following
• Review of any side effects you have experienced and all medications you are taking
• Performance Status
• Review and Physical exam
• Routine blood tests
• Questionnaire to evaluate symptoms of neuropathy
• CT scans