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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)

Phase 2
18 Years
Open (Enrolling)
Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia

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Trial Information

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)

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 cyotogenetic
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

- 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

- 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 > or = to 18 years

- Karnofsky performance status > or = to 50%

- Hematologic parameters:

Absolute neutrophil count (ANC) > or = to 1000/μl

- Platelets > 50k/ μl

Biochemical parameters:

- Total bilirubin < or = to 2.0 mg/dl AST and ALT < or = to 2.5 x upper limits of

- Creatinine < or = to 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess the safety

Outcome 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.

Outcome Time Frame:

at weeks 2 and 4 with routine toxicity assessments throughout the trial

Safety Issue:


Principal Investigator

Peter Maslak, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

December 2010

Completion Date:

December 2013

Related Keywords:

  • Acute Myeloid Leukemia
  • Acute Lymphoblastic Leukemia
  • vaccine
  • 10-143
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid



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