Trial of a WT-1 Analog Peptide Vaccine in Patients With Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL)
|ClinicalTrials.gov Identifier: NCT01266083|
Recruitment Status : Active, not recruiting
First Posted : December 24, 2010
Last Update Posted : February 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia Acute Lymphoblastic Leukemia||Biological: WT1 peptide vaccine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Actual Study Start Date :||December 2010|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
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.
- To assess the safety [ Time Frame: at weeks 2 and 4 with routine toxicity assessments throughout the trial ]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 ]The primary efficacy measure is defined as overall survival at 3 years.
- Disease free survival and overall survival [ Time Frame: 5 years ]
- To assess the immunologic responses of vaccine administration [ Time Frame: at week 12 ]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 ]as measured by RT-PCR for WT1 transcript.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01266083
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Peter Maslak, MD||Memorial Sloan Kettering Cancer Center|