Trial of a WT-1 Analog Peptide Vaccine in Patients With Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL)
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ClinicalTrials.gov Identifier: NCT01266083 |
Recruitment Status
:
Active, not recruiting
First Posted
: December 24, 2010
Last Update Posted
: February 26, 2018
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Condition or disease | Intervention/treatment | Phase |
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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) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
---|---|
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).
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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.
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- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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 |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Memorial Sloan Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT01266083 History of Changes |
Other Study ID Numbers: |
10-143 |
First Posted: | December 24, 2010 Key Record Dates |
Last Update Posted: | February 26, 2018 |
Last Verified: | February 2018 |
Keywords provided by Memorial Sloan Kettering Cancer Center:
MONTANIDE ISA 51 WT1 PEPTIDE SPECIFIC T CELLS vaccine 10-143 |
Additional relevant MeSH terms:
Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Vaccines Neoplasms by Histologic Type |
Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Immunologic Factors Physiological Effects of Drugs |