Clinical Trials /

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

NCT01266083

Description:

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

Related Conditions:
  • Acute Lymphoblastic Leukemia
  • Acute Myeloid Leukemia
Recruiting Status:

Completed

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Trial of a WT-1 Analog Peptide Vaccine in Patients With Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL)
  • 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)

Clinical Trial IDs

  • ORG STUDY ID: 10-143
  • NCT ID: NCT01266083

Conditions

  • Acute Myeloid Leukemia
  • Acute Lymphoblastic Leukemia

Interventions

DrugSynonymsArms
WT1 peptide vaccineWT1 peptide vaccine

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
WT1 peptide vaccineExperimentalThis 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).
  • WT1 peptide vaccine

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:To assess the safety
Time Frame:at weeks 2 and 4 with routine toxicity assessments throughout the trial
Safety Issue:
Description: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.

Secondary Outcome Measures

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

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:Memorial Sloan Kettering Cancer Center

Trial Keywords

  • MONTANIDE ISA 51
  • WT1 PEPTIDE SPECIFIC T CELLS
  • vaccine
  • 10-143

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