Clinical trial NCT01282476: Panobinostat With Rituximab for Relapsed/Refractory Diffuse Large B Cell Lymphoma
Official title: Panobinostat in Combination With Rituximab For Relapsed/Refractory Diffuse Large B Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Diffuse Large B Cell Lymphoma
Keywords: DLBCL (Diffuse Large B Cell Lymphoma)
Panobinostat
LBH589 (Panobinostat)
LBH-589 (Panobinostat)
HDAC inhibitor (Histone deacetylase inhibitor)
DAC inhibitor (deacetylase inhibitor)
deacetylase inhibitor
lymphoma
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Dana-Farber Cancer Institute
name: Beth Israel Deaconess Medical Center
First posted: 2011-01-25
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall Response Rate
timeFrame: 1 year
Secondary outcomes:
measure: Progression-free Survival Rate
timeFrame: 6 months
measure: Toxicities
timeFrame: 1 year
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Jeremy S Abramson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cheson BD, Pfistner B, Juweid ME, Gascoyne RD, Specht L, Horning SJ, Coiffier B, Fisher RI, Hagenbeek A, Zucca E, Rosen ST, Stroobants S, Lister TA, Hoppe RT, Dreyling M, Tobinai K, Vose JM, Connors JM, Federico M, Diehl V; International Harmonization Project on Lymphoma. Revised response criteria for malignant lymphoma. J Clin Oncol. 2007 Feb 10;25(5):579-86. doi: 10.1200/JCO.2006.09.2403. Epub 2007 Jan 22.