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Trial record 29 of 878 for:    LENALIDOMIDE

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

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ClinicalTrials.gov Identifier: NCT01460940
Recruitment Status : Completed
First Posted : October 27, 2011
Results First Posted : March 14, 2017
Last Update Posted : November 14, 2017
Sponsor:
Collaborators:
Celgene
Novartis
Information provided by (Responsible Party):
Ohio State University Comprehensive Cancer Center

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
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lenalidomide and Panobinostat
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 24
Completed 24
Not Completed 0
Arm/Group Title Lenalidomide and Panobinostat
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 24 participants
45
(22 to 72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Female
7
  29.2%
Male
17
  70.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 24 participants
24
1.Primary Outcome
Title Determine the Overall Response Rate (ORR), Including Complete Responses (CR) and Partial Responses (PR)
Hide Description Overall response rate (CR + PR) will be determined using the International response criteria with combined panobinostat and lenalidomide in patients with relapsed or refractory Hodgkin's lymphoma.
Time Frame up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lenalidomide and Panobinostat
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 24
Measure Type: Number
Unit of Measure: percentage of patients
16.7
2.Secondary Outcome
Title Assess the Safety and Tolerability of Combined Lenalidomide and Panobinostat in Patients With Previously Treated Hodgkin's Lymphoma.
Hide Description Safety and tolerability will be assessed for patients using the NIH-NCI Common Terminology Criteria (CTCAE) version 4.0
Time Frame up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Grade 3-4 toxicities
Arm/Group Title Lenalidomide and Panobinostat
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 24
Measure Type: Number
Unit of Measure: percentage of patients
neutropenia 58.3
thrombocytopenia 41.7
febrile neutropenia 25.0
hypophosphatemia 25.0
3.Secondary Outcome
Title Progression-free Survival in Patients With Previously Treated Hodgkin's Lymphoma Receiving Combined Lenalidomide and Panobinostat
Hide Description Determined from the date of start of therapy to death from any cause or censored at the last date the patient is known to be alive
Time Frame 3-5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lenalidomide and Panobinostat
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 24
Median (95% Confidence Interval)
Unit of Measure: months
3.8
(1.8 to 5.9)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lenalidomide and Panobinostat
Hide Arm/Group Description

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.

All-Cause Mortality
Lenalidomide and Panobinostat
Affected / at Risk (%)
Total   0/24 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Lenalidomide and Panobinostat
Affected / at Risk (%) # Events
Total   17/24 (70.83%)    
Blood and lymphatic system disorders   
Thrombocytopenia  1  1/24 (4.17%)  1
Neutropenia  1  3/24 (12.50%)  3
Gastrointestinal disorders   
Dehydration  1  1/24 (4.17%)  1
Nausea/vomiting  1  1/24 (4.17%)  1
Infections and infestations   
Febrile Neutropenia  1  4/24 (16.67%)  4
Infection without Neutropenia  1  2/24 (8.33%)  2
Investigations   
Fatigue  2  1/24 (4.17%)  1
Metabolism and nutrition disorders   
Hyponatremia  1  1/24 (4.17%)  1
Hyperbilirubinemia/Transaminitis  1  1/24 (4.17%)  1
Psychiatric disorders   
Altered Mental Status  1  1/24 (4.17%)  1
Skin and subcutaneous tissue disorders   
Rash  1  1/24 (4.17%)  1
1
Term from vocabulary, CTCAE version 4.0
2
Term from vocabulary, CTCAE version
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lenalidomide and Panobinostat
Affected / at Risk (%) # Events
Total   24/24 (100.00%)    
Blood and lymphatic system disorders   
Febrile Neutropenia  1  2/24 (8.33%)  2
Thrombocytopenia  1  9/24 (37.50%)  9
Infections and infestations   
Neutropenia  1  11/24 (45.83%)  11
Infection without Neutropenia  1  2/24 (8.33%)  2
Investigations   
Lymphopenia  1  6/24 (25.00%)  6
Metabolism and nutrition disorders   
Hypokalemia  1  2/24 (8.33%)  2
Hypophosphatemia  1  2/24 (8.33%)  2
Hyperbilirubinemia/Transaminitis  1  2/24 (8.33%)  2
1
Term from vocabulary, CTCAE version 4.0
Indicates events were collected by systematic assessment
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
Responsible Party: 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) )
First Submitted: October 14, 2011
First Posted: October 27, 2011
Results First Submitted: January 24, 2017
Results First Posted: March 14, 2017
Last Update Posted: November 14, 2017