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

NCT01282476 | Terminated Phase 2 Results DMC

• 1 other identifier: 10-441
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 3

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.

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

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  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)

  1 year

Secondary Outcomes (2)

• Progression-free Survival Rate

  6 months

• Toxicities

  1 year

Study Arms (1)

Panobinostat/Rituximab

EXPERIMENTAL

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

Interventions

Panobinostat with Rituximab DRUG

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.

Also known as: LBH589, LBH-569, Rituxan

Panobinostat/Rituximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Relapsed or refractory DLBCL
• More than 1 line of prior chemotherapy

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Dana-Farber Cancer Institute: collaborator
• Beth Israel Deaconess Medical Center: collaborator

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02214, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• 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.

  PMID: 17242396 BACKGROUND

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Dendritic Cell Sarcoma, Interdigitating; Lymphoma

Interventions

Panobinostat; Rituximab

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Histiocytic Disorders, Malignant; Histiocytosis

Intervention Hierarchy (Ancestors)

Hydroxamic Acids; Hydroxylamines; Amines; Organic Chemicals; Hydroxy Acids; Carboxylic Acids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Jeremy Abramson, MD
• Organization: Massachusetts General Hospital Cancer Center

jabramson@mgh.harvard.edu

617-724-4000

Study Officials

• Jeremy S Abramson, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Lymphoma Program

Study Record Dates

• First Submitted: January 21, 2011
• First Posted: January 25, 2011
• Study Start: June 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2014
• Last Updated: May 9, 2017
• Results First Posted: March 31, 2017

Record last verified: 2017-04

Locations

US (3)