Patient Summary of AMC-075

AMC-075
A Sequential Phase I/Randomized Phase II Trial of Vorinostat and Risk-Adapted
Chemotherapy with Rituximab in HIV-Related B-Cell Non-Hodgkin’s Lymphoma
HIV-related B-cell Non-Hodgkin’s Lymphoma
Why this study is being done



This study is being done to find more effective treatments for non-Hodgkin’s
lymphoma in people with HIV.
Vorinostat (Zolinza®) is approved for the treatment of another type of lymphoma, and
is currently being tested in clinical trials for many cancers. By adding this drug to
traditional chemotherapy, AMC investigators hope to improve current treatment
options and long-term survival for your type of lymphoma.
The study will also examine whether adding vorinostat to traditional lymphoma
therapy (Rituximab plus dose-adjusted EPOCH) will have a positive effect in
eliminating HIV and other viruses that are linked with lymphoma.
What this study involves

Clinical Trial Design: In this Phase II study, a computer program randomly assigns
you by chance (50/50, like the flip of a coin) to receive standard treatment alone or
with vorinostat. Neither you nor your doctor can choose the group you will be in. The
study will compare the response rates (how well the treatment gets rid of the
cancer) and recurrence rates (whether and how fast the cancer returns) of those who
receive chemotherapy with and without vorinostat. This will help us see whether
adding vorinostat makes the standard lymphoma treatment more effective.
PHASE II
Non-Hodgkin lymphoma
Randomization

Arm E:
Arm F:
Vorinostat +
R-EPOCH
R-EPOCH
alone
In this study, you will receive either vorinostat by mouth and
Rituximab-EPOCH chemotherapy (Arm E) or R-EPOCH chemotherapy (Arm F)
alone every three weeks repeated up to six times. R-EPOCH chemotherapy is
routine treatment for your type of lymphoma. Giving you vorinostat plus
chemotherapy is considered “experimental”.
Who may take part in the study?

Up to 90 patients will take part in this Phase II study.
You will need to have a few tests that are normally done in patients with lymphoma
before you are ready to start the trial to determine if you are eligible. Such tests
include:
–
Checking the function of your heart
–
Several blood draws
–
Exams to find out where lymphoma is in your body–including body scans, a
spinal fluid tap, and a bone marrow biopsy.
How long will treatment last?
Treatment is expected to last four and a half months.
For more information, please contact or visit:

Kelly Petrowski, AMC Study Coordinator, Ruth M. Rothstein CORE Center
 312-572-4551 (phone)
 312-942-6000 #1582 (pager)
 [email protected] (email)

http://www.cancer.gov/clinicaltrials

ClinicalTrials.gov
Registration number: NCT01193842
http://clinicaltrials.gov/ct/show/NCT01193842

For more information about the AMC, visit http://www.AIDScancer.org/

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