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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 (electrocardiograms) will be done weekly in Cycle 1 and then once in each cycle. PET/CT (Positron Emission Tomography/Computed Tomography) scans will be done every 2 months. 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.

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

Conditions
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Diffuse Large B Cell Lymphoma

Intervention / Treatment
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* Drug: Panobinostat with Rituximab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Panobinostat/Rituximab<br>single-arm, open-label; Panobinostat with Rituximab: Panobinostat 40 mg orally 3 x weekly Rituximab 375 mg/m^2 IV days 1,8,15,and 22 of cycle 1, and then on day 1 of subsequent cycles. | Drug: Panobinostat with Rituximab<br>* Panobinostat 40 mg orally 3 x weekly Rituximab 375 mg/m^2 IV days 1,8,15,and 22 of cycle 1, and then on day 1 of subsequent cycles.<br>* Other names: Rituxan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate | Overall response rate is defined by the Revised International Workshop Response Criteria (2007) (see reference in protocol section). Overall response (OR) = Complete response (CR) + Partial response (PR) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival Rate | Progression is defined by the Revised International Workshop Response Criteria (2007) (see reference in protocol section). | 6 months | 
| Toxicities | Evaluate safety of this combination in relapsed/refractory DLBCL patients Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DLBCL (Diffuse Large B Cell Lymphoma), Panobinostat, LBH589 (Panobinostat), LBH-589 (Panobinostat), HDAC inhibitor (Histone deacetylase inhibitor), DAC inhibitor (deacetylase inhibitor), deacetylase inhibitor, lymphoma