Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of Oral LBH589 in Adult Patients With Refractory/Resistant Cutaneous T-Cell Lymphoma

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.
 
ClinicalTrials.gov Identifier: NCT00490776
Recruitment Status : Completed
First Posted : June 25, 2007
Last Update Posted : February 24, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
This study will evaluate the safety and efficacy of LBH589B in adult patients with refractory/resistant Cutaneous T-Cell Lymphoma and prior HDAC inhibitor therapy.

Condition or disease Intervention/treatment Phase
Cutaneous T-Cell Lymphoma Drug: LBH589 Phase 2 Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Oral LBH589 in Adult Patients With Cutaneous T-Cell Lymphoma Who Are Intolerant to or Have Progressed on or After Prior HDAC Inhibitor
Study Start Date : June 2007
Actual Primary Completion Date : September 2009


Arm Intervention/treatment
Experimental: LBH589 Drug: LBH589
Other Name: panobinostat




Primary Outcome Measures :
  1. To determine the overall response rate of patients treated with LBH589 by using the modified Severity-Weighted Assessment Tool to assess skin disease and the evaluation of disease in the viscera, lymph nodes, and blood (circulation SS cells) [ Time Frame: Monthly ]

Secondary Outcome Measures :
  1. To determine the response rate using the Physicians Global Assessment of Clinical Condition(PGA)of patients with resistant CTCL [ Time Frame: Monthly ]
  2. To determine the response rate using Modified Severity Weighted Assessment (mSWAT) skin score of patients with resistant CTCL [ Time Frame: Monthly ]
  3. Responses in index lesions by lesion measurements with photographic supporting documentation [ Time Frame: Monthly ]
  4. Overall response rate of patients with resistant CTCL treated with oral LBH589 by using the modified Physician's Global Assessment (PGA) to assess skin disease and the evaluation of disease in the viscera, lymph nodes and blood (circulating SS cells). [ Time Frame: Monthly ]
  5. Duration of response [ Time Frame: Monthly ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Written informed consent obtained prior to any screening procedures
  2. Age greater than or equal to 18 years old
  3. Patients with biopsy-confirmed stages IB-IVA mycosis fungoides or Sézary syndrome. Patients with SS who have bone marrow involvement are also eligible. Patients with transformed CTCL are eligible.
  4. Patients must have been treated with an HDAC inhibitor given for the treatment of CTCL. Patients must have had disease progression on or following treatment with an HDAC inhibitor. Patients are also eligible if they had an inadequate response to an HDAC inhibitor defined as stable disease as the best response after at least 3 months of therapy. Patients previously treated with an HDAC inhibitor are also eligible if they experienced intolerance due to adverse events.

Exclusion criteria:

  1. Patients with a history of visceral disease including CNS involvement (i.e. stage IVB CTCL). Note, patients who have SS with bone marrow involvement are eligible.
  2. Impaired cardiac function
  3. Concomitant use of drugs with a risk of causing torsades de pointes
  4. Patients who have received chemotherapy or any investigational drug or undergone major surgery ≤ 3 weeks prior to starting study drug or who have not recovered from side effects of such therapy
  5. Less than 3 months since prior electron beam therapy
  6. Women who are pregnant or breast feeding, or women of childbearing potential (WOCBP) not willing to use a double method of contraception during the study and 3 months after the end of treatment.

Other protocol-defined inclusion/exclusion criteria may apply


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): NCT00490776


Locations
Show Show 18 study locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Layout table for investigator information
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Additional Information:
Layout table for additonal information
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00490776    
Other Study ID Numbers: CLBH589B2212
First Posted: June 25, 2007    Key Record Dates
Last Update Posted: February 24, 2017
Last Verified: February 2017
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Cutaneous T-Cell Lymphoma
adults
Mycosis Fungoides
Sézary Syndrome
CTCL
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Panobinostat
Antineoplastic Agents
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action