ClinicalTrials.gov
ClinicalTrials.gov Menu

Panobinostat in Treating Patients With Relapsed or Refractory Non-Hodgkin 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: NCT01261247
Recruitment Status : Active, not recruiting
First Posted : December 16, 2010
Results First Posted : May 17, 2018
Last Update Posted : May 17, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Adult Nasal Type Extranodal NK/T-cell Lymphoma
Anaplastic Large Cell Lymphoma
Angioimmunoblastic T-cell Lymphoma
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Hepatosplenic T-cell Lymphoma
Nodal Marginal Zone B-cell Lymphoma
Peripheral T-cell Lymphoma
Post-transplant Lymphoproliferative Disorder
Recurrent Adult Burkitt Lymphoma
Recurrent Adult Diffuse Large Cell Lymphoma
Recurrent Adult Lymphoblastic Lymphoma
Recurrent Adult T-cell Leukemia/Lymphoma
Recurrent Grade 1 Follicular Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Recurrent Grade 3 Follicular Lymphoma
Recurrent Mantle Cell Lymphoma
Recurrent Mycosis Fungoides/Sezary Syndrome
Recurrent Small Lymphocytic Lymphoma
Small Intestine Lymphoma
Splenic Marginal Zone Lymphoma
Waldenstrom Macroglobulinemia
Interventions: Drug: panobinostat
Other: laboratory biomarker analysis
Genetic: western blotting
Genetic: DNA analysis
Other: flow cytometry
Other: pharmacological study
Other: immunohistochemistry staining method

  Participant Flow

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
Arm I (LBH589) Patients receive oral 40 mg panobinostat 3 times weekly. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Participant Flow:   Overall Study
    Arm I (LBH589)
STARTED   41 
COMPLETED   39 
NOT COMPLETED   2 
Ineligible                2 



  Baseline Characteristics

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.
Baseline characteristics are summarized for patients who completed the study.

Reporting Groups
  Description
Arm I (LBH589) Patients receive oral 40 mg panobinostat 3 times weekly. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Baseline Measures
   Arm I (LBH589) 
Overall Participants Analyzed 
[Units: Participants]
 39 
Age 
[Units: Years]
Median (Full Range)
 61.0 
 (37.0 to 86.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      12  30.8% 
Male      27  69.2% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   39 


  Outcome Measures

1.  Primary:   Proportion of Confirmed Responses Defined to be a CR or PR Noted as the Objective Status   [ Time Frame: Every 28 days for up to 2 years ]

2.  Secondary:   Median Overall Survival Time   [ Time Frame: Every 6 months for up to 2 years ]

3.  Secondary:   Median Progression-free Survival Time   [ Time Frame: Every 6 months for up to 2 years ]

4.  Secondary:   Duration of Response   [ Time Frame: Every 6 months for up to 2 years ]

5.  Other Pre-specified:   Pharmacokinetic/Pharmacodynamic of LBH589 and Correlation With Clinical Effects as Assessed by Immunoblotting, SNPs Analysis, Serum Cytokine Assays, and Flow Cytometry for Suppressive Monocytes (Correlative Studies)   [ Time Frame: At baseline and day 1 of courses 3, 5, 7 and every three courses thereafter for up to 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Patrick Johnston, MD, PhD
Organization: Mayo Clinic Cancer Center
phone: 507-284-2511
e-mail: johnston.patrick@mayo.edu



Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT01261247     History of Changes
Other Study ID Numbers: MC0986
NCI-2010-02326 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
10-004705 ( Other Identifier: Mayo Clinic IRB )
CLBH589BUS59T ( Other Identifier: Novartis Protocol )
MC0986 ( Other Identifier: Mayo Clinic Cancer Center )
First Submitted: December 14, 2010
First Posted: December 16, 2010
Results First Submitted: April 19, 2018
Results First Posted: May 17, 2018
Last Update Posted: May 17, 2018