This trial is active, not recruiting.

Condition diffuse large b cell lymphoma
Treatment panobinostat with rituximab
Phase phase 2
Sponsor Massachusetts General Hospital
Collaborator Dana-Farber Cancer Institute
Start date June 2011
End date July 2014
Trial size 25 participants
Trial identifier NCT01282476, 10-441


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
panobinostat with rituximab LBH589
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.

Primary Outcomes

Overall response rate
time frame: 1 year

Secondary Outcomes

Progression-free survival and duration of response
time frame: 1 year
Evaluate safety of this combination in relapsed/refractory DLBCL patients
time frame: 1 year
Evaluate the impact of baseline expression of BCL6 and pAKT on response
time frame: 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Panobinostat in Combination With Rituximab For Relapsed/Refractory Diffuse Large B Cell Lymphoma
Principal investigator Jeremy S Abramson, MD
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 will be done weekly in Cycle 1 and then once in each cycle. PET/CT 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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.