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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 : February 11, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

Study Type Interventional
Study Design Allocation: N/A;   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
Enrollment 41
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I (LBH589)
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 41
Completed 39
Not Completed 2
Reason Not Completed
Ineligible             2
Arm/Group Title Arm I (LBH589)
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 39
Hide Baseline Analysis Population Description
Baseline characteristics are summarized for patients who completed the study.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 39 participants
61.0
(37.0 to 86.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants
Female
12
  30.8%
Male
27
  69.2%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 39 participants
39
 100.0%
1.Primary Outcome
Title Proportion of Confirmed Responses Defined to be a CR or PR Noted as the Objective Status
Hide Description The primary endpoint of this phase II trial is the proportion of confirmed responses (complete response (CR) or partial response (PR)) noted as the objective status and will be considered synonymous with "success" for this study.Response will be evaluated using all cycles of treatment. A CR is defined using the Cheson et al. Revised Response Criteria for Malignant Lymphoma as Disappearance of all evidence of disease. A PR is defined as Regression of measurable disease and no new sites with ≥50% decrease in SPD of up to 6 largest dominant masses; no increase in size of other nodes. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients.
Time Frame Every 28 days for up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who completed the study were evaluable for the primary outcome. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response.
Arm/Group Title Arm I (LBH589)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 39
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of CR or PR patients
0.21
(0.07 to 0.38)
2.Secondary Outcome
Title Median Overall Survival Time
Hide Description The median overall survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.
Time Frame Every 6 months for up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (LBH589)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 39
Median (95% Confidence Interval)
Unit of Measure: months
14.9
(8.8 to 46.4)
3.Secondary Outcome
Title Median Progression-free Survival Time
Hide Description The median progression-free survival time is defined as the time from registration to progression or death due to any cause. The distribution of progression-free survival will be estimated using the method of Kaplan-Meier. Progression is defined using the Cheson et al. Revised Response Criteria for Malignant Lymphoma as: Any new lesion or increase by ≥50% of previously involved sites from nadir, Appearance of a new lesion(s) > 1.5 cm in any axis, ≥50% increase from nadir in SPD of more than one node, or ≥50% increase in longest diameter of a previously identified node > 1 cm in short axis, Lesions PET positive if FDG-avid lymphoma or PET positive prior to therapy, > 50% increase from nadir in the SPD of any previous lesions, New or recurrent involvement.
Time Frame Every 6 months for up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (LBH589)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 39
Median (95% Confidence Interval)
Unit of Measure: months
3.1
(2.0 to 8.4)
4.Secondary Outcome
Title Duration of Response
Hide Description Duration of response is defined for all evaluable patients who have achieved a confirmed response as the date at which the patient's objective status is first noted to be a CR or PR to the earliest date progression (PD) is documented. The distribution of duration of response will be estimated using the method of Kaplan-Meier. (CR: Disappearance of all evidence of disease, PR: Regression of measurable disease and no new sites, PD: Any new lesion or increase by ≥50% of previously involved sites from nadir).
Time Frame Every 6 months for up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who achieved a confirmed response were included in this analysis.
Arm/Group Title Arm I (LBH589)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 8
Median (95% Confidence Interval)
Unit of Measure: months
19.7
(15.1 to 28.1)
5.Other Pre-specified Outcome
Title 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)
Hide Description [Not Specified]
Time Frame At baseline and day 1 of courses 3, 5, 7 and every three courses thereafter for up to 2 years
Outcome Measure Data Not Reported
Time Frame Up to 25 months
Adverse Event Reporting Description CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
 
Arm/Group Title Arm I (LBH589)
Hide Arm/Group Description 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.
All-Cause Mortality
Arm I (LBH589)
Affected / at Risk (%)
Total   0/41 (0.00%)    
Hide Serious Adverse Events
Arm I (LBH589)
Affected / at Risk (%) # Events
Total   34/41 (82.93%)    
Blood and lymphatic system disorders   
Anemia  1  6/41 (14.63%)  9
Febrile neutropenia  1  1/41 (2.44%)  1
Cardiac disorders   
Atrial fibrillation  1  1/41 (2.44%)  1
Gastrointestinal disorders   
Abdominal pain  1  1/41 (2.44%)  1
Diarrhea  1  2/41 (4.88%)  2
Intra-abdominal hemorrhage  1  1/41 (2.44%)  1
General disorders   
Fatigue  1  4/41 (9.76%)  4
Fever  1  1/41 (2.44%)  2
Infections and infestations   
Enterocolitis infectious  1  1/41 (2.44%)  2
Lung infection  1  3/41 (7.32%)  7
Skin infection  1  1/41 (2.44%)  1
Upper respiratory infection  1  2/41 (4.88%)  2
Injury, poisoning and procedural complications   
Postoperative hemorrhage  1  1/41 (2.44%)  1
Investigations   
Electrocardiogram QT corrected interval prolonged  1  1/41 (2.44%)  1
INR increased  1  1/41 (2.44%)  1
Lymphocyte count decreased  1  3/41 (7.32%)  3
Neutrophil count decreased  1  12/41 (29.27%)  18
Platelet count decreased  1  33/41 (80.49%)  46
Serum amylase increased  1  1/41 (2.44%)  1
White blood cell decreased  1  8/41 (19.51%)  10
Metabolism and nutrition disorders   
Dehydration  1  1/41 (2.44%)  1
Hypertriglyceridemia  1  1/41 (2.44%)  2
Hyponatremia  1  1/41 (2.44%)  2
Hypophosphatemia  1  2/41 (4.88%)  2
Renal and urinary disorders   
Renal calculi  1  1/41 (2.44%)  2
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  1/41 (2.44%)  1
Vascular disorders   
Hypertension  1  1/41 (2.44%)  1
Hypotension  1  2/41 (4.88%)  2
1
Term from vocabulary, MedDRA 12
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I (LBH589)
Affected / at Risk (%) # Events
Total   38/41 (92.68%)    
Blood and lymphatic system disorders   
Anemia  1  11/41 (26.83%)  20
Gastrointestinal disorders   
Abdominal pain  1  1/41 (2.44%)  1
Constipation  1  1/41 (2.44%)  1
Diarrhea  1  31/41 (75.61%)  98
Dyspepsia  1  2/41 (4.88%)  4
Nausea  1  29/41 (70.73%)  63
Vomiting  1  15/41 (36.59%)  20
General disorders   
Edema limbs  1  1/41 (2.44%)  1
Fatigue  1  35/41 (85.37%)  159
Infections and infestations   
Lung infection  1  2/41 (4.88%)  3
Sinusitis  1  1/41 (2.44%)  1
Upper respiratory infection  1  1/41 (2.44%)  7
Investigations   
Alkaline phosphatase increased  1  1/41 (2.44%)  1
CD4 lymphocytes decreased  1  2/41 (4.88%)  2
CPK increased  1  1/41 (2.44%)  1
Creatinine increased  1  1/41 (2.44%)  7
Lymphocyte count decreased  1  6/41 (14.63%)  8
Neutrophil count decreased  1  17/41 (41.46%)  83
Platelet count decreased  1  19/41 (46.34%)  61
Weight loss  1  2/41 (4.88%)  3
White blood cell decreased  1  15/41 (36.59%)  47
Metabolism and nutrition disorders   
Anorexia  1  8/41 (19.51%)  9
Dehydration  1  1/41 (2.44%)  1
Hyperglycemia  1  3/41 (7.32%)  3
Hypertriglyceridemia  1  5/41 (12.20%)  18
Hypoalbuminemia  1  1/41 (2.44%)  1
Hypoglycemia  1  1/41 (2.44%)  1
Hypophosphatemia  1  4/41 (9.76%)  5
Nervous system disorders   
Dysgeusia  1  4/41 (9.76%)  15
Headache  1  1/41 (2.44%)  1
Renal and urinary disorders   
Chronic kidney disease  1  1/41 (2.44%)  4
Vascular disorders   
Hypertension  1  1/41 (2.44%)  2
1
Term from vocabulary, MedDRA 12
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Patrick Johnston, MD, PhD
Organization: Mayo Clinic Cancer Center
Phone: 507-284-2511
EMail: johnston.patrick@mayo.edu
Layout table for additonal information
Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT01261247    
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: February 11, 2020