Panobinostat With Rituximab for Relapsed/Refractory Diffuse Large B Cell Lymphoma

Therapuetic Areas:Oncology
Age Range:18 - Any
Start Date:June 2011
Contact:Christine Connolly

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Panobinostat in Combination With Rituximab For Relapsed/Refractory Diffuse Large B Cell Lymphoma

Panobinostat is a drug that may slow down the growth of cancer cells or kill cancer cells by
blocking certain enzymes. Panobinostat has shown effects against cancer in laboratory
studies. However, it is not known if it will show the same activity in humans.
Panobinostat has been given to participants with various types of cancers, including DLBCL,
in previous research studies. In this study panobinostat will be given with the the
antibody rituximab, which is FDA approved to be given with chemotherapy in DLBCL.

Study treatment will be given in 4 week periods called cycles. Panobinostat will be taken
orally on Monday, Wednesday, and Friday of each week. Rituximab will be given as an
intravenous infusion weekly during Cycle 1 and then once per month on day 1 of subsequent
cycles. Subjects can receive up to 6 cycles of treatment. Blood draws and 2 EKGs will be
done weekly in Cycle 1 and then once in each cycle. PET/CT scans will be done every 2

If disease has not progressed after 6 cycles on combination of panobinostat and rituximab,
subjects may continue on panobinostat alone for up to 6 additional months.

Inclusion Criteria:

- Relapsed or refractory DLBCL

- More than 1 line of prior chemotherapy

Exclusion Criteria:

- Currently receiving anticancer therapy or investigational agents

- Major surgery within last 4 weeks

- Known leptomeningeal or brain metastases

- Known HIV infection

- Uncontrolled fungal, bacterial, viral or other infection

- History of another malignancy (except for non-melanoma skin cancer or in situ
cervical or breast cancer) unless disease free for at least 3 years

- Hepatitis B or C positive

- GI disease

- Pregnant or breastfeeding

- Prior treatment with an HDAC inhibitor including valproic acid
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