Description:
To determine whether the WT1 vaccine causes an immune response which is safe and able to keep
the leukemia from coming back.
Title
- Brief Title: WT-1 Analog Peptide Vaccine in 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
Drug | Synonyms | Arms |
---|
WT1 peptide vaccine | | WT1 peptide vaccine |
Purpose
To determine whether the WT1 vaccine causes an immune response which is safe and able to keep
the leukemia from coming back.
Detailed Description
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
Name | Type | Description | Interventions |
---|
WT1 peptide vaccine | Experimental | 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). | |
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 |
Time Frame: | 5 years |
Safety Issue: | |
Description: | Disease free survival |
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. |
Measure: | Overall survival |
Time Frame: | 5 years |
Safety Issue: | |
Description: | Overall survival |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Completed |
Lead Sponsor: | Sellas Life Sciences Group |
Trial Keywords
- MONTANIDE ISA 51
- WT1 PEPTIDE SPECIFIC T CELLS
- vaccine
- 10-143
Last Updated
November 30, 2018