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

This study is currently recruiting participants.
Verified June 2012 by Massachusetts General Hospital

First Received on January 21, 2011.  
Last Updated on June 12, 2012  
History of Changes
This Clinical Trial Sponsored By: Massachusetts General Hospital
Collaborators: Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party): Jeremy Abramson, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01282476
 

Purpose for Clinical Trial

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.

Condition Study Intervention Clinical Trial Phase
Diffuse Large B Cell Lymphoma Drug: Panobinostat with Rituximab Phase 2

Study Type: Study Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Study Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Panobinostat in Combination With Rituximab For Relapsed/Refractory Diffuse Large B Cell Lymphoma

Resource links provided by NLM:

MedlinePlus related topics:
Cancer
Lymphoma
Drug Information available for:
Rituximab

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures For Clinical Trial:

  • Overall response rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures For Clinical Trial:

  • Progression-free survival and duration of response [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Evaluate safety of this combination in relapsed/refractory DLBCL patients [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Evaluate the impact of baseline expression of BCL6 and pAKT on response [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: June 2011
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)

Arms

Assigned Study Interventions

Experimental: Panobinostat/Rituximab Drug: 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.
Other Names:
  • LBH589
  • LBH-569
  • Rituxan

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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01282476

Contacts
Contact: Christine Connolly 617-726-5131 cconnolly1@partners.org
Contact: Jeremy Abramson, MD 617-726-8743 jabramson@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02214
Principal Investigator: Jeremy S Abramson, MD            
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Principal Investigator: David C Fisher, MD            
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Principal Investigator: Robin Joyce, MD            
Sponsors and Collaborators
Massachusetts General Hospital
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Investigators

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