Trial of a WT-1 Analog Peptide Vaccine in Patients With Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL)
The purpose of this study is to determine whether the WT1 vaccine causes an immune response which is safe and able to keep the leukemia from coming back. While vaccines have been used in infectious diseases like smallpox and measles,the idea about using vaccines in a cancer like AML/ALL is really a new use of the idea of vaccines.The WT-1 vaccine is made up of protein pieces that the immune system can recognize as abnormal. The doctor thinks that the WT-1 protein is important in AML/ALL and using some lab tests they are still able to find some of it in the bone marrow. By attacking this small amount of the protein they hope to get rid of any small amount of AML that is still in the body.
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Biological: WT1 peptide vaccine
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of a WT-1 Analog Peptide Vaccine in Patients in Complete Remission (CR) From Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL)|
- To assess the safety [ Time Frame: at weeks 2 and 4 with routine toxicity assessments throughout the trial ] [ Designated as safety issue: Yes ]of the WT1 peptide vaccine administered to patients in CR from AML. Early toxicity will be assessed at weeks 2 and 4,. Routine toxicity assessments will continue throughout the trial. Any toxicity noted in the trial will be graded in accordance with Common Toxicity Criteria, version 4.0 (CTCAE 4.0) developed by the National Cancer Institute.
- To assess the efficacy of the WT1 peptide vaccine administered to patients in CR from AML. [ Time Frame: 3 years ] [ Designated as safety issue: No ]The primary efficacy measure is defined as overall survival at 3 years.
- Disease free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- To assess the immunologic responses of vaccine administration [ Time Frame: at week 12 ] [ Designated as safety issue: No ]via CD4+ T cell proliferation, CD3+ T cell interferon- γ release (ELISPOT and / or flow cytometry) and WT1 peptide tetramer staining.
- To assess any effect on minimal residual disease [ Time Frame: at week 12 ] [ Designated as safety issue: No ]as measured by RT-PCR for WT1 transcript.
|Study Start Date:||December 2010|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Experimental: WT1 peptide vaccine
This is a Phase II study evaluating the safety and efficacy of the WT1 peptide vaccine in patients who are in CR from Acute Myeloid Leukemia (AML).
Biological: WT1 peptide vaccine
Six vaccinations of the WT1 peptide preparation (1.0 ml of emulsion) will be administered on weeks 0, 2, 4, 6, 8, and 10. All vaccinations will be administered subcutaneously with vaccination sites rotated among extremities. Patients who are clinically stable and have not had disease progression, may receive up to 6 more vaccinations administered appropriately every month.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01266083
|Contact: Peter Maslak, MD||212-639-5518|
|Contact: Renier Brentjens, MD, PhD||212-639-7053|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Peter Maslak, MD 212-639-5518|
|Contact: Renier Brentjens, MD, PhD 212-639-7053|
|Principal Investigator: Peter Maslak, MD|
|Principal Investigator:||Peter Maslak, MD||Memorial Sloan Kettering Cancer Center|