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

This study has been terminated.
(Pharmaceutical company request.)
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT01090973
First received: March 18, 2010
Last updated: November 21, 2013
Last verified: January 2012
Results First Received: January 27, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Non-Hodgkin's Lymphoma
Intervention: Drug: LBH589

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Oral Drug Treatment 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.

Participant Flow:   Overall Study
    Oral Drug Treatment  
STARTED     1  
COMPLETED     0  
NOT COMPLETED     1  
Disease progression                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Oral Drug Treatment 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.

Baseline Measures
    Oral Drug Treatment  
Number of Participants  
[units: participants]
  1  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     0  
>=65 years     1  
Gender  
[units: participants]
 
Female     0  
Male     1  
Region of Enrollment  
[units: participants]
 
United States     1  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Desired Response   [ Time Frame: 8 weeks (2 cycles) unless treatment continues due to partial or complete response ]

2.  Secondary:   Number of Participants With Complete Response (CR) and Partial Response (PR)   [ Time Frame: 8 weeks (2 cycles) unless treatment continues due to partial or complete response ]

3.  Secondary:   Response Duration   [ Time Frame: 8 weeks (2 cycles) unless treatment continues due to partial or complete response ]

4.  Secondary:   Progression Free Survival (PFS) Estimate   [ Time Frame: 8 weeks (2 cycles) unless treatment continues due to partial or complete response ]

5.  Secondary:   Number of Participants With Prolonged Corrected QT (QTc) Interval   [ Time Frame: 8 weeks (2 cycles) unless treatment continues due to partial or complete response ]

6.  Secondary:   Number of Participants With Improved Blood and Lymphatic Evaluation Results   [ Time Frame: 8 weeks (2 cycles) unless treatment continues due to partial or complete response ]

7.  Secondary:   Number of Participants With Adverse Events (AEs)   [ Time Frame: 8 weeks (2 cycles) unless treatment continues due to partial or complete response ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data

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.



  More Information
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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
e-mail: celeste.bello@moffitt.org


No publications provided


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, CLBH589B25T
Study First Received: March 18, 2010
Results First Received: January 27, 2012
Last Updated: November 21, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board