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Trial record 15 of 138 for:    lbh-589

Oral LBH589 in Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) and Mantle Cell Lymphoma (MCL)

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ClinicalTrials.gov Identifier: NCT01090973
Recruitment Status : Terminated (Pharmaceutical company request.)
First Posted : March 23, 2010
Results First Posted : March 28, 2012
Last Update Posted : December 16, 2013
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non-Hodgkin's Lymphoma
Intervention Drug: LBH589
Enrollment 1
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Oral Drug Treatment
Hide Arm/Group Description LBH589 was to be given orally (by mouth), 40 mg once-a-day, 3 times weekly every week on days 1, 3 & 5, then 8, 10 &12, then 15, 17 & 19, then 22, 24 & 26.
Period Title: Overall Study
Started 1
Completed 0
Not Completed 1
Reason Not Completed
Disease progression             1
Arm/Group Title Oral Drug Treatment
Hide Arm/Group Description LBH589 was to be given orally (by mouth), 40 mg once-a-day, 3 times weekly every week on days 1, 3 & 5, then 8, 10 &12, then 15, 17 & 19, then 22, 24 & 26.
Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
<=18 years
0
   0.0%
Between 18 and 65 years
0
   0.0%
>=65 years
1
 100.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
0
   0.0%
Male
1
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants
1
1.Primary Outcome
Title Number of Participants With Desired Response
Hide Description

Investigators intended to assess the rate of overall and complete response by World Health Organization (WHO) classification in patients with relapsed or refractory aggressive mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL).

WHO Performance Scale Measures levels of patient capability: 0 Normal activity; 1 Symptoms, but nearly fully ambulatory; 2 Some bed time, but needs to be in bed <50% of normal daytime; 3 Needs to be in bed >50% of normal daytime; 4 Unable to get out of bed.

Time Frame 8 weeks (2 cycles) unless treatment continues due to partial or complete response
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

The study was abandoned after only one patient due to low accrual and the sponsor losing interest in the single-agent.

The one patient had disease progression requiring more aggressive treatment and did not complete the study.

Arm/Group Title Oral Drug Treatment
Hide Arm/Group Description:
LBH589 was to be given orally (by mouth), 40 mg once-a-day, 3 times weekly every week on days 1, 3 & 5, then 8, 10 &12, then 15, 17 & 19, then 22, 24 & 26.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Number of Participants With Complete Response (CR) and Partial Response (PR)
Hide Description

Investigators intended to determine the complete and partial responses. Chronic Lymphocytic Leukemia (CLL): Using the NCI criteria - - See definitions in the Detailed Description section for a Complete hematologic Remission, and Partial Response.

Mantle Cell Lymphoma (MCL): Based on the International Workshop to Standardize Response Criteria to NHL (Cheson, JCO 1999) - See definitions in the Detailed Description section for a Complete hematologic Remission, and Partial Response.

Time Frame 8 weeks (2 cycles) unless treatment continues due to partial or complete response
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

The study was abandoned after only one patient due to low accrual and the sponsor losing interest in the single-agent.

The one patient had disease progression requiring more aggressive treatment and did not complete the study.

Arm/Group Title Oral Drug Treatment
Hide Arm/Group Description:
LBH589 was to be given orally (by mouth), 40 mg once-a-day, 3 times weekly every week on days 1, 3 & 5, then 8, 10 &12, then 15, 17 & 19, then 22, 24 & 26.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Response Duration
Hide Description Investigators intended to determine the duration of responses.
Time Frame 8 weeks (2 cycles) unless treatment continues due to partial or complete response
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

The study was abandoned after only one patient due to low accrual and the sponsor losing interest in the single-agent.

The one patient had disease progression requiring more aggressive treatment and did not complete the study.

Arm/Group Title Oral Drug Treatment
Hide Arm/Group Description:
LBH589 was to be given orally (by mouth), 40 mg once-a-day, 3 times weekly every week on days 1, 3 & 5, then 8, 10 &12, then 15, 17 & 19, then 22, 24 & 26.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Progression Free Survival (PFS) Estimate
Hide Description Investigators intended to estimate the progression free survival time
Time Frame 8 weeks (2 cycles) unless treatment continues due to partial or complete response
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

The study was abandoned after only one patient due to low accrual and the sponsor losing interest in the single-agent.

The one patient had disease progression requiring more aggressive treatment and did not complete the study.

Arm/Group Title Oral Drug Treatment
Hide Arm/Group Description:
LBH589 was to be given orally (by mouth), 40 mg once-a-day, 3 times weekly every week on days 1, 3 & 5, then 8, 10 &12, then 15, 17 & 19, then 22, 24 & 26.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Number of Participants With Prolonged Corrected QT (QTc) Interval
Hide Description Investigators intended to monitor the QTc interval in patients receiving oral LBH589
Time Frame 8 weeks (2 cycles) unless treatment continues due to partial or complete response
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral Drug Treatment
Hide Arm/Group Description:
LBH589 was to be given orally (by mouth), 40 mg once-a-day, 3 times weekly every week on days 1, 3 & 5, then 8, 10 &12, then 15, 17 & 19, then 22, 24 & 26.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Number of Participants With Improved Blood and Lymphatic Evaluation Results
Hide Description Investigators intended to evaluate histone acetylation, cytotoxic mixed lymphocyte reaction (MLR) activity, cytokine profiles, and immunologic synapse alterations through peripheral blood correlative studies
Time Frame 8 weeks (2 cycles) unless treatment continues due to partial or complete response
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

The study was abandoned after only one patient due to low accrual and the sponsor losing interest in the single-agent.

The one patient had disease progression requiring more aggressive treatment and did not complete the study.

Arm/Group Title Oral Drug Treatment
Hide Arm/Group Description:
LBH589 was to be given orally (by mouth), 40 mg once-a-day, 3 times weekly every week on days 1, 3 & 5, then 8, 10 &12, then 15, 17 & 19, then 22, 24 & 26.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Number of Participants With Adverse Events (AEs)
Hide Description

Investigators intended to evaluate the safety and tolerability profile of LBH589. Assessments would consist of monitoring and recording all adverse events and serious adverse events, the regular monitoring of hematology, blood chemistry and urine values, vital signs, ECOG performance status, and the regular physical examinations and ECG assessments.

Adverse events will be assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 3.0. CTCAE v3.0 can be accessed on the National Institute of Health (NIH)/NCI website at http://ctep.cancer.gov/forms/CTCAEv3.pdf.

Time Frame 8 weeks (2 cycles) unless treatment continues due to partial or complete response
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

The study was abandoned after only one patient due to low accrual and the sponsor losing interest in the single-agent.

The one patient had disease progression requiring more aggressive treatment and did not complete the study.

Arm/Group Title Oral Drug Treatment
Hide Arm/Group Description:
LBH589 was to be given orally (by mouth), 40 mg once-a-day, 3 times weekly every week on days 1, 3 & 5, then 8, 10 &12, then 15, 17 & 19, then 22, 24 & 26.
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: participants
1
Time Frame 46 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Oral Drug Treatment
Hide Arm/Group Description LBH589 was to be given orally (by mouth), 40 mg once-a-day, 3 times weekly every week on days 1, 3 & 5, then 8, 10 &12, then 15, 17 & 19, then 22, 24 & 26.
All-Cause Mortality
Oral Drug Treatment
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Oral Drug Treatment
Affected / at Risk (%) # Events
Total   1/1 (100.00%)    
Blood and lymphatic system disorders   
Death not associated with CTCAE term - Disease progression NOS  1 [1]  1/1 (100.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
Grade 5. Unrelated to study drug.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Oral Drug Treatment
Affected / at Risk (%) # Events
Total   1/1 (100.00%)    
Gastrointestinal disorders   
Hemorrhage, GI - Upper GI NOS  1 [1]  1/1 (100.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
Grade 3. Unrelated to study drug.

The study was abandoned after only one patient due to low accrual and the sponsor losing interest in the single-agent.

The one patient had disease progression requiring more aggressive treatment and did not complete the study.

Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Celeste Bello, M.D.
Organization: H. Lee Moffitt Cancer Center and Research Institute
Phone: 813-745-8623
Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT01090973     History of Changes
Other Study ID Numbers: MCC-15971
IRB # Pro00000102 ( Other Identifier: USF Institutional Review Board )
CLBH589B25T ( Other Identifier: Novartis )
First Submitted: March 18, 2010
First Posted: March 23, 2010
Results First Submitted: January 27, 2012
Results First Posted: March 28, 2012
Last Update Posted: December 16, 2013