Panobinostat in Combination With Rituximab For Relapsed/Refractory Diffuse Large B Cell Lymphoma
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Enrollment
- 18
- Locations
- 3
- Primary Endpoint
- Overall Response Rate
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Panobinostat/Rituximab
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.
Intervention: Panobinostat with Rituximab (Drug)
Outcomes
Primary Outcomes
Overall Response Rate
Time Frame: 1 year
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)
Secondary Outcomes
- Toxicities(1 year)
- Progression-free Survival Rate(6 months)
Investigators
Jeremy Abramson, MD
Director, Lymphoma Program
Massachusetts General Hospital