WT-1 Analog Peptide Vaccine in Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL)

Study Overview
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Brief Summary
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To determine whether the WT1 vaccine causes an immune response which is safe and able to keep the leukemia from coming back.

Detailed Description
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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.

Official Title
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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)

Conditions
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Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia

Intervention / Treatment
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* Biological: WT1 peptide vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Morphologic confirmation of a diagnosis of AML or ALL at MSKCC Patients will have completed induction therapy, achieved 1st CR and will have completed any planned postremission therapy. Patients are not candidates for allogeneic stem cell transplantation. For purposes of this study, patients who are not candidates for allogeneic stem cell transplantation shall be defined as 1) those who do not meet the eligibility criteria of an open allogeneic transplant protocol or 2) those who do not have a suitable available HLA matched donor available or 3) those who refuse to undergo stem cell transplantation or 4) those patients whose disease is characterized by good risk features (For AML the following cytogenetic subtypes: t(8;21), inv (16), or t(16;16), t(15;17), normal karyotype with mutated NPM1 and negative for tandem duplication of FLT-3. For ALL: T cell phenotype of any B lineage disease exclusive of t(9;22) or t(4;11) in whom allogenic stem cell transplantation in 1st CR would not be offered as standard of care. Alternatively, those patients greater than or equal to 60 years of age who have achieved 1st CR and in whom no further postremission chemotherapy is planned may be enrolled Patients must have documented WT1 + disease. For purpose of this study, this is defined as detectable presence of any WT1 transcript via RT-PCR on a bone marrow performed at MSKCC within 4 weeks prior to the administration of the first dose of vaccine. Patients must be within 2 years of achieving CR following chemotherapy At least 4 weeks must have elapsed between the patient's last chemotherapy or radiation treatment and the first vaccination. Age ≥ 18 years Karnofsky performance status ≥ 50% Hematologic parameters: Absolute neutrophil count (ANC) ≥ 1000/μl Platelets > 50k/ μl Biochemical parameters: Total bilirubin ≤ 2.0 mg/dl AST and ALT ≤ 2.5 x upper limits of normal Creatinine ≤ 2.0 mg/dl Exclusion Criteria: Pregnant or lactating women Patients with documented evidence of leptomeningeal disease Patients who have undergone autologous or allogeneic stem cell transplantation Patients with active infection requiring systemic antimicrobials Patients taking systemic corticosteroids Patients with serious unstable medical illness

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WT1 peptide vaccine<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety | 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. | at weeks 2 and 4 with routine toxicity assessments throughout the trial | 
| To assess the efficacy of the WT1 peptide vaccine administered to patients in CR from AML. | The primary efficacy measure is defined as overall survival at 3 years. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival | Disease free survival | 5 years | 
| To assess the immunologic responses of vaccine administration | via CD4+ T cell proliferation, CD3+ T cell interferon- γ release (ELISPOT and / or flow cytometry) and WT1 peptide tetramer staining. | at week 12 | 
| To assess any effect on minimal residual disease | as measured by RT-PCR for WT1 transcript. | at week 12 | 
| Overall survival | Overall survival | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MONTANIDE ISA 51, WT1 PEPTIDE SPECIFIC T CELLS, vaccine, 10-143