Duke logo

AHOD1331 Randomized Phase III Study for Newly Diagnosed Classical Hodgkin Lymphoma - Clinical Trial

What is the Purpose of this Study?

We are doing this study to compare the effects (good and/or bad) of standard treatment and when brentuximab vedotin is added to standard treatment in newly diagnosed high-risk Hodgkin lymphoma patients to find out which one is better.

What is the Condition Being Studied?

Newly Diagnosed High-Risk Classical Hodgkin Lymphoma (cHL) in Children and Young Adults

Who Can Participate in the Study?

Children or young adults who:
- Are age 2-22
- Are newly diagnosed Classical Hodgkin Lymphoma
- Have no previous chemo or radiation therapy

Age Group
Adults, Children

What is Involved?

If you choose to be in the study, you will:

- Be randomized (like the flip of a coin) to get either:

1. Standard Treatment: Get 5 cycles (21 days each) of Doxorubicin (A), bleomycin (B), vincristine (V), etoposide (E), prednisone (P) and cyclophosphamide (C)

2. Experimental Treatment: Get 5 cycles (21 days each) of treatment with the following drugs: Brentuximab vedotin (Bv), doxorubicin (A), vincristine (V), etoposide (E), prednisone (P) and cyclophosphamide (C).

- Get an evaluation by PET or CT scans to see how the disease is responding to treatment.
- Get Response Adapted Targeted Radiation if needed.
- Have your parent fill out questionnaires regarding financial costs at each time point

Study Details

Full Title
AHOD1331 A Randomized Phase III Study of Brentuximab Vedotin (SGN-35, IND #117117) for Newly Diagnosed High-Risk Classical Hodgkin Lymphoma (cHL) in Children and Adolescents
Principal Investigator
Pediatric Hematology-Oncology Specialist
Protocol Number
IRB:PRO00065203
NCT:NCT02166463
Phase
Phase III
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
studyrecruitment@duke.edu
or
919-681-5698