A Phase II Trial of Panobinostat and Lenalidomide in Patients With Relapsed or Refractory Hodgkin's Lymphoma
|ClinicalTrials.gov Identifier: NCT01460940|
Recruitment Status : Completed
First Posted : October 27, 2011
Results First Posted : March 14, 2017
Last Update Posted : November 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|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||Drug: panobinostat Drug: lenalidomide||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Panobinostat and Lenalidomide in Patients With Relapsed or Refractory Hodgkin's Lymphoma|
|Study Start Date :||October 13, 2011|
|Actual Primary Completion Date :||November 16, 2016|
|Actual Study Completion Date :||November 16, 2016|
Experimental: 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.
Administered orally Monday, Wednesday, Friday of every week for 4 weeks. A cycle is define as 28 days.
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.
- Determine the Overall Response Rate (ORR), Including Complete Responses (CR) and Partial Responses (PR) [ Time Frame: up to 24 months ]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.
- Assess the Safety and Tolerability of Combined Lenalidomide and Panobinostat in Patients With Previously Treated Hodgkin's Lymphoma. [ Time Frame: up to 24 months ]Safety and tolerability will be assessed for patients using the NIH-NCI Common Terminology Criteria (CTCAE) version 4.0
- Progression-free Survival in Patients With Previously Treated Hodgkin's Lymphoma Receiving Combined Lenalidomide and Panobinostat [ Time Frame: 3-5 years ]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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01460940
|United States, Missouri|
|Saint Louis, Missouri, United States, 63110|
|United States, Ohio|
|The Ohio State University Medical Center|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Kristie Blum, MD||Ohio State University|