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

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia	Biological: WT1 peptide vaccine	Phase 2

Study Design

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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

Arms and Interventions

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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).

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.

Outcome Measures

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Primary Outcome Measures :

1. 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.
2. 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.

Secondary Outcome Measures :

1. Disease free survival and overall survival [ Time Frame: 5 years ]
2. 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.
3. To assess any effect on minimal residual disease [ Time Frame: at week 12 ]
   as measured by RT-PCR for WT1 transcript.

Eligibility Criteria

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

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

Contacts and Locations

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Locations

United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065

Sponsors and Collaborators

Memorial Sloan Kettering Cancer Center

Investigators

Principal Investigator:	Peter Maslak, MD	Memorial Sloan Kettering Cancer Center

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Memorial Sloan Kettering Cancer Center 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Maslak PG, Dao T, Bernal Y, Chanel SM, Zhang R, Frattini M, Rosenblat T, Jurcic JG, Brentjens RJ, Arcila ME, Rampal R, Park JH, Douer D, Katz L, Sarlis N, Tallman MS, Scheinberg DA. Phase 2 trial of a multivalent WT1 peptide vaccine (galinpepimut-S) in acute myeloid leukemia. Blood Adv. 2018 Feb 13;2(3):224-234. doi: 10.1182/bloodadvances.2017014175.

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
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