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

Acute Myeloid Leukemia Clinical Trial

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 Details — Status: Completed

Administrative data

• NCT number: NCT01266083
• Other study ID #: 10-143
• Status: Completed
• Phase: Phase 2
• Start date: December 2010
• Est. completion date: February 2018

Study information

• Verified date: November 2018
• Source: Sellas Life Sciences Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Lymphoid
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Sellas Life Sciences Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the safety	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.	at weeks 2 and 4 with routine toxicity assessments throughout the trial
Primary	To assess the efficacy of the WT1 peptide vaccine administered to patients in CR from AML.	The primary efficacy measure is defined as overall survival at 3 years.	3 years
Secondary	Disease free survival	Disease free survival	5 years
Secondary	To assess the immunologic responses of vaccine administration	via CD4+ T cell proliferation, CD3+ T cell interferon- ? release (ELISPOT and / or flow cytometry) and WT1 peptide tetramer staining.	at week 12
Secondary	To assess any effect on minimal residual disease	as measured by RT-PCR for WT1 transcript.	at week 12
Secondary	Overall survival	Overall survival	5 years

External Links

•   Memorial Sloan Kettering Cancer Center