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A Phase II Trial of Panobinostat and Lenalidomide in Patients With Relapsed or Refractory Hodgkin's Lymphoma

This study has been completed.
Sponsor:
Collaborators:
Celgene
Novartis
Information provided by (Responsible Party):
Kristie Blum, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01460940
First received: October 14, 2011
Last updated: January 24, 2017
Last verified: January 2017
Results First Received: January 24, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Adult Lymphocyte Depletion Hodgkin Lymphoma
Adult Lymphocyte Predominant Hodgkin Lymphoma
Adult Mixed Cellularity Hodgkin Lymphoma
Adult Nodular Lymphocyte Predominant Hodgkin Lymphoma
Adult Nodular Sclerosis Hodgkin Lymphoma
Recurrent Adult Hodgkin Lymphoma
Interventions: Drug: panobinostat
Drug: lenalidomide

  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
Lenalidomide and Panobinostat

In the phase I trial, three patients will be enrolled at each dose level, starting at dose level 1 using a standard 3 + 3 dose escalation phase I design.

panobinostat: Administered orally Monday, Wednesday, Friday of every week for 4 weeks. A cycle is define as 28 days.

lenalidomide: Lenalidomide will be administered orally daily on days 1-21. Lenalidomide will not be given on days 22-28. A cycle is define as 28 days.


Participant Flow:   Overall Study
    Lenalidomide and Panobinostat
STARTED   24 
COMPLETED   24 
NOT COMPLETED   0 



  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
Lenalidomide and Panobinostat

In the phase I trial, three patients will be enrolled at each dose level, starting at dose level 1 using a standard 3 + 3 dose escalation phase I design.

panobinostat: Administered orally Monday, Wednesday, Friday of every week for 4 weeks. A cycle is define as 28 days.

lenalidomide: Lenalidomide will be administered orally daily on days 1-21. Lenalidomide will not be given on days 22-28. A cycle is define as 28 days.


Baseline Measures
   Lenalidomide and Panobinostat 
Overall Participants Analyzed 
[Units: Participants]
 24 
Age 
[Units: Years]
Median (Full Range)
 45 
 (22 to 72) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      7  29.2% 
Male      17  70.8% 
Region of Enrollment 
[Units: Participants]
 
United States   24 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Determine the Overall Response Rate (ORR), Including Complete Responses (CR) and Partial Responses (PR)   [ Time Frame: up to 24 months ]

2.  Secondary:   Assess the Safety and Tolerability of Combined Lenalidomide and Panobinostat in Patients With Previously Treated Hodgkin's Lymphoma.   [ Time Frame: up to 24 months ]

3.  Secondary:   Progression-free Survival in Patients With Previously Treated Hodgkin's Lymphoma Receiving Combined Lenalidomide and Panobinostat   [ Time Frame: 3-5 years ]


  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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Kristie Blum
Organization: The Ohio State University Comprehensive Cancer Center
phone: 614-293-4590
e-mail: Kristie.Blum@osumc.edu



Responsible Party: Kristie Blum, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01460940     History of Changes
Other Study ID Numbers: OSU-10049
NCI-2011-03323 ( Registry Identifier: Clinical Trial Reporting Program (CTRP) )
Study First Received: October 14, 2011
Results First Received: January 24, 2017
Last Updated: January 24, 2017