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

This study has been terminated.
(slow accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01282476
First Posted: January 25, 2011
Last Update Posted: May 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Jeremy Abramson, MD, Massachusetts General Hospital
  Purpose
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 Intervention Phase
Diffuse Large B Cell Lymphoma Drug: Panobinostat with Rituximab Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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:


Further study details as provided by Jeremy Abramson, MD, Massachusetts General Hospital:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Progression-free Survival Rate [ Time Frame: 6 months ]
    Progression is defined by the Revised International Workshop Response Criteria (2007) (see reference in protocol section).

  • Toxicities [ Time Frame: 1 year ]
    Evaluate safety of this combination in relapsed/refractory DLBCL patients Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening


Enrollment: 18
Actual Study Start Date: June 2011
Study Completion Date: August 2014
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01282476


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02214
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Massachusetts General Hospital
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Jeremy S Abramson, MD Massachusetts General Hospital
  More Information

Additional Information:
Publications:
Responsible Party: Jeremy Abramson, MD, Director, Lymphoma Program, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01282476     History of Changes
Other Study ID Numbers: 10-441
First Submitted: January 21, 2011
First Posted: January 25, 2011
Results First Submitted: February 14, 2017
Results First Posted: March 31, 2017
Last Update Posted: May 9, 2017
Last Verified: April 2017

Keywords provided by Jeremy Abramson, MD, Massachusetts General Hospital:
DLBCL (Diffuse Large B Cell Lymphoma)
Panobinostat
LBH589 (Panobinostat)
LBH-589 (Panobinostat)
HDAC inhibitor (Histone deacetylase inhibitor)
DAC inhibitor (deacetylase inhibitor)
deacetylase inhibitor
lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Panobinostat
Rituximab
Histone Deacetylase Inhibitors
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action