Immunotherapy Using Lenalidomide + Bystander Vaccine in High Risk Myelodysplastic Syndrome (MDS)
|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: NCT00840931|
Recruitment Status : Active, not recruiting
First Posted : February 11, 2009
Last Update Posted : September 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Drug: lenalidomide Biological: bystander vaccine||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Pilot Study of Immunotherapy Using Lenalidomide Plus "Bystander" Vaccine in Patients With High-Risk Myelodysplastic Syndrome (MDS)|
|Actual Study Start Date :||February 2, 2009|
|Actual Primary Completion Date :||February 17, 2014|
|Estimated Study Completion Date :||June 2019|
Participants will take two 5 mg capsules of lenalidomide per day for 21 days followed by 7 days of rest. This 28 day period is considered 1 cycle. Participants will receive 4 treatment cycles with 28 days in each cycle. Those participants showing a clinical response after 4 cycles of treatment may continue to receive lenalidomide as a single agent for additional cycles at the treating Physicians discretion. During each 28 day cycle participants will also receive GM.CD40L bystander vaccination injections in 2-week intervals on days 8 and 22 for a total of 8 immunizations during the 4 cycle treatment period.
Patients will take 10 mg capsules of lenalidomide per day for 21 days followed by 7 days of rest. This 28 day period is considered 1 cycle. Patients will receive 4 treatment cycles with 28 days in each cycle.
Other Name: Revlimid®
Biological: bystander vaccine
In addition to lenalidomide, during each 28 day cycle patients will also receive GM.CD40L bystander vaccination injections in 2-week intervals on days 8 and 22 for a total of 8 immunizations during the 4 cycle treatment period.
Other Name: GM.CD40L
- Maximum Tolerated Dose (MTD) [ Time Frame: 24 months ]Determination of MTD of GM.CD40L bystander vaccine with lenalidomide in high-risk MDS patients.
- Number of Participants with Toxicities [ Time Frame: 24 months ]Determination of toxicities associated with combination of GM.CD40L bystander vaccine with lenalidomide in high-risk MDS patients.
- Number of Participants with Augmentation of Specific T Cell Immunological Functions [ Time Frame: 24 months ]Augmentation of specific T cell immunological functions; T cell proliferation and Interferon-γ production, delayed type hypersensitivity (DTH) sensitivity by lenalidomide.
- Number of Participants with Reduction of Bone Marrow Myeloblast [ Time Frame: 24 months ]Reduction of bone marrow myeloblast from baseline to post treatment with lenalidomide and GM.CD40L bystander vaccine.
- Number of Participants with Improvement of Hemoglobin and/or red blood cell (RBC) Transfusion Independence [ Time Frame: 24 months ]Improvement of hemoglobin and/or RBC transfusion independence after combined immunotherapy treatment.
- Number of Participants with Resolution of Karyotypic Changes [ Time Frame: 24 months ]Resolution of karyotypic changes after combined treatment.
- Number of Participants with Augmentation of Other T Cell Parameters [ Time Frame: 24 months ]Augmentation of other T cell parameters after the combined treatment.
- Duration of Response [ Time Frame: 24 months ]Determination of response duration evaluated by Wilms Tumor 1 (WT1) expression and clinical outcomes. Clinical response will be assessed using International Working Group (IWG) criteria.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00840931
|United States, Florida|
|H. Lee Moffitt Cancer Center & Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Javier Pinilla, M.D., Ph.D.||H. Lee Moffitt Cancer & Research Institute|