CLINICAL TRIAL SUMMARY

MDACC Study No:2012-0661 (clinicaltrials.gov NCT No: NCT01712490)
Title:A Randomized, Open-label, Phase 3 Trial of A+AVD Versus ABVD as Frontline Therapy in
Patients With Advanced Classical Hodgkin Lymphoma
Principal Investigator:Yasuhiro Oki
Treatment Agent:Bleomycin; Dacarbazine; Doxorubicin; SGN-35; Vinblastine
Study Status:Open
Study Description:The goal of this clinical research study is to compare the effects of 2
different drug combinations on HL. The safety of these drug combinations will
also be studied.

The 2 drug combinations being used on this study are :
adriamycin (doxorubicin), vinblastine, and dacarbazine (together known as AVD),
in combination with brentuximab vedotin; and
adriamycin (doxorubicin), bleomycin, vinblastine, and dacarbazine (together
known as ABVD)

AVD and ABVD are both designed to stop the growth of cancer cells, which may
cause the cells to die.

Brentuximab vedotin (also called ADCERTIS) is made up of 2 parts. The first
part is designed to attach to a protein called CD30. CD30 is found on some
normal cells in the body’s immune system and on some types of cancer, such as
HL. The second part of brentuximab vedotin may kill the cancer cells that the
first part targeted.

Participants in this study will be assigned to either Arm A or Arm B (described
below). If you decide to participate in the study and receive treatment in Arm
A, you will also be asked to give blood and tumor samples for biomarker
research (including genetic research). Biomarkers are in the blood and tissue
and may be related to your disease. They may allow doctors to identify
patients who are more likely to respond to or develop side effects from
ADCETRIS and to study how differences in biomarkers may influence the way
people respond to ADCETRIS. This research is being done to develop a better
understanding of how people’s genes affect the safety and effectiveness of
ADCETRIS, to help develop new ways to monitor and treat cancer, to generate
information needed for development of diagnostic tests related to diseases or
conditions that ADCETRIS might treat.

Hide details for General InformationGeneral Information

Disease Group:Lymphoma
Phase of Study:Phase III
Treatment Agents:Bleomycin
Dacarbazine
Doxorubicin
SGN-35
Vinblastine
Treatment Location:Both at MDACC & and Other Sites
Estimated Length of Stay in Houston:
Supported By:Millennium Pharmaceuticals, Inc.
Return Visit:
Home Care:


Hide details for Study Contact InformationStudy Contact Information

Physician Name:Yasuhiro Oki
Dept:Lymphoma
For Clinical Trial Enrollment:713-792-2806
For General Questions about Clinical Trials:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)


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