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

Primary Purpose

Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

WT1 peptide vaccine

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring MONTANIDE ISA 51, WT1 PEPTIDE SPECIFIC T CELLS, vaccine, 10-143

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

WT1 peptide vaccine

Arm Description

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).

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Disease free survival

To assess the immunologic responses of vaccine administration

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

as measured by RT-PCR for WT1 transcript.

Overall survival

Full Information

NCT ID

NCT01266083

First Posted

December 21, 2010

Last Updated

November 28, 2018

Sponsor

Sellas Life Sciences Group

1. Study Identification

Unique Protocol Identification Number

NCT01266083

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)

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Completed

Study Start Date

December 2010 (Actual)

Primary Completion Date

February 2018 (Actual)

Study Completion Date

February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sellas Life Sciences Group

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia

Keywords

MONTANIDE ISA 51, WT1 PEPTIDE SPECIFIC T CELLS, vaccine, 10-143

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

WT1 peptide vaccine

Arm Type

Experimental

Arm Description

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).

Intervention Type

Biological

Intervention Name(s)

WT1 peptide vaccine

Intervention Description

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.

Primary Outcome Measure Information:

Title

To assess the safety

Description

Time Frame

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

Title

To assess the efficacy of the WT1 peptide vaccine administered to patients in CR from AML.

Description

The primary efficacy measure is defined as overall survival at 3 years.

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Disease free survival

Description

Disease free survival

Time Frame

5 years

Title

To assess the immunologic responses of vaccine administration

Description

via CD4+ T cell proliferation, CD3+ T cell interferon- γ release (ELISPOT and / or flow cytometry) and WT1 peptide tetramer staining.

Time Frame

at week 12

Title

To assess any effect on minimal residual disease

Description

as measured by RT-PCR for WT1 transcript.

Time Frame

at week 12

Title

Overall survival

Description

Overall survival

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter Maslak, MD

Organizational Affiliation

Memorial Sloan Kettering Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Memorial Sloan Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

29386195

Citation

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.

Results Reference

derived

Links:

URL

http://www.mskcc.org/mskcc/html/44.cfm

Description

Memorial Sloan Kettering Cancer Center

Learn more about this trial

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

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