ClinicalTrials.gov
ClinicalTrials.gov Menu

Panobinostat and Everolimus in Treating Patients With Recurrent Multiple Myeloma, Non-Hodgkin Lymphoma, or 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: NCT00918333
Recruitment Status : Active, not recruiting
First Posted : June 11, 2009
Results First Posted : May 18, 2018
Last Update Posted : May 18, 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
B-cell Adult Acute Lymphoblastic Leukemia
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Hepatosplenic T-cell Lymphoma
Nodal Marginal Zone B-cell Lymphoma
Post-transplant Lymphoproliferative Disorder
Primary Central Nervous System Non-Hodgkin Lymphoma
Recurrent Adult Acute Lymphoblastic Leukemia
Recurrent Adult Burkitt Lymphoma
Recurrent Adult Diffuse Large Cell Lymphoma
Recurrent Adult Hodgkin Lymphoma
Recurrent Adult Lymphoblastic Lymphoma
Recurrent Adult T-cell Leukemia/Lymphoma
Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
Recurrent Grade 1 Follicular Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Recurrent Grade 3 Follicular Lymphoma
Recurrent Mantle Cell Lymphoma
Recurrent Marginal Zone Lymphoma
Recurrent Mycosis Fungoides/Sezary Syndrome
Recurrent Small Lymphocytic Lymphoma
Refractory Chronic Lymphocytic Leukemia
Refractory Multiple Myeloma
Splenic Marginal Zone Lymphoma
T-cell Adult Acute Lymphoblastic Leukemia
Waldenström Macroglobulinemia
Interventions: Drug: panobinostat
Drug: everolimus
Other: laboratory biomarker analysis
Other: pharmacological study

  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
Phase I (Panobinostat + Everolimus) Patients receive 10, 15, 20, 30 or 40 mg/day panobinostat PO 3 times/week or on days 1, 3, 5, 15, 17, and 19 and 5 or 10 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Phase II (Panobinostat + Everolimus) Patients receive 20,30, or 40 mg/day panobinostat PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Participant Flow:   Overall Study
    Phase I (Panobinostat + Everolimus)   Phase II (Panobinostat + Everolimus)
STARTED   26   98 
COMPLETED   23   93 
NOT COMPLETED   3   5 
Drug not taken per protocol                1                0 
Inadequate amount of drugs provided                1                4 
Ineligible                1                0 
Withdrawal by Subject                0                1 



  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.
No text entered.

Reporting Groups
  Description
Phase I (Panobinostat + Everolimus) Patients receive 10, 15, 20, 30 or 40 mg/day panobinostat PO 3 times/week or on days 1, 3, 5, 15, 17, and 19 and 5 or 10 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Phase II (Panobinostat + Everolimus) Patients receive 20,30, or 40 mg/day panobinostat PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Total Total of all reporting groups

Baseline Measures
   Phase I (Panobinostat + Everolimus)   Phase II (Panobinostat + Everolimus)   Total 
Overall Participants Analyzed 
[Units: Participants]
 23   93   116 
Age 
[Units: Years]
Median (Full Range)
 61.0 
 (24.0 to 73.0) 
 59.0 
 (20.0 to 84.0) 
 59.5 
 (20.0 to 84.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      6  26.1%      28  30.1%      34  29.3% 
Male      17  73.9%      65  69.9%      82  70.7% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   23   93   116 


  Outcome Measures

1.  Primary:   Number of Phase I Participants With Dose-Limiting Toxicity Events (Phase I)   [ Time Frame: 4 weeks ]

2.  Primary:   Overall Response Rate (Phase II)   [ Time Frame: Up to 12 courses ]

3.  Secondary:   Overall Survival Time (Phase II)   [ Time Frame: Time from registration to death due to any cause, assessed up to 2 years post-treatment ]

4.  Secondary:   Progression-free Survival (Phase II)   [ Time Frame: Time from registration to progression or death due to any cause, assessed up to 2 years post-treatment ]

5.  Secondary:   Duration of Response (Phase II)   [ Time Frame: The time from the date at which the patient’s objective status is first noted to be a CR, sCR, VGPR, PR, or minor response to the earliest date progression is documented, assessed up to 2 years post-treatment ]

6.  Other Pre-specified:   Change in Pharmacologic (Pharmacokinetic/Pharmacodynamic) Parameters   [ Time Frame: Day 5 and 19 of the first course and then day 1 of each subsequent courses (courses 2-4) prior to the daily dose and 1 and 2 hours after each dose ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

7.  Other Pre-specified:   Changes in Biological Markers   [ Time Frame: Baseline to up to 12 courses ]
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: Shaji Kumar, MD
Organization: Mayo Clinic Cancer Center
phone: 507-284-2511
e-mail: Kumar.shaji@mayo.edu



Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00918333     History of Changes
Obsolete Identifiers: NCT01417559
Other Study ID Numbers: MC0886
NCI-2009-00934 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
08-004746
CLBH589BUS17T
MC0886 ( Other Identifier: Mayo Clinic )
P30CA015083 ( U.S. NIH Grant/Contract )
First Submitted: June 1, 2009
First Posted: June 11, 2009
Results First Submitted: April 19, 2018
Results First Posted: May 18, 2018
Last Update Posted: May 18, 2018