WT1 Vaccine Treatment of Patients in Remission From Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL)

NCT ID: NCT01266083

Last Updated: 2024-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-14
• Study Completion Date: 2016-09-30

Brief Summary

This trial will assess the safety and efficacy of vaccination with galinpepimut-S (GPS), a WT1 peptide vaccine, in patients who are in complete remission from leukemia.

Participants will receive vaccinations with GPS every 2 weeks for 10 weeks (a total of 6 vaccinations). In the absence of disease recurrence at Week 12 and if clinically stable after the first 6 vaccinations, participants may continue to receive up to six more vaccinations every month.

Detailed Description

This clinical study is conducted in patients in complete remission from acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL). The primary objective is to assess the effect of vaccination with galinpepimut-S (GPS) on patient survival and the safety profile.

Galinpepimut-S (GPS) consists of four WT1-derived peptides which have been chosen to strengthen antigenicity, but also broaden immunogenicity over a wide range of HLA subtypes, being able to stimulate both CD8+ (MHC Class I)- and CD4+ (MHC Class II)-dependent responses. Galinpepimut-S is administered with the adjuvant Montanide and sargramostim (GM-CSF).

Participants will receive vaccinations with GPS every 2 weeks for 10 weeks (a total of 6 vaccinations). In the absence of disease recurrence at Week 12 evaluation and if clinically stable after the first 6 vaccinations, participants may continue to receive up to six more vaccinations every month. Following the last vaccination, participants will be followed regularly (every 1 to 3 months) in an outpatinet setting for up to 3 years from the first treatment date.

Conditions

Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Galinpepimut-S + Montanide + GM-CSF

Galinpepimut-S (GPS) and Montanide (in a 1 mL emulsion) are administered subcutaneously (s.c.) Q2W on weeks 0, 2, 4, 6, 8, and 10. GM-CSF (70 μg) are administered s.c. one to two days before and on the day of GPS/Montanide administration. Participants with no recurrence after Week 12 and who are clinically stable may be eligible to receive up to 6 additional monthly vaccinations.

Group Type: EXPERIMENTAL

Galinpepimut-S

Intervention Type: BIOLOGICAL

Galinpepimut-S admixed with the adjuvant Montanide following specified schedule

GM-CSF

Intervention Type: BIOLOGICAL

subcutaneous injection

Montanide

Intervention Type: OTHER

adjuvant

Interventions

Galinpepimut-S

Galinpepimut-S admixed with the adjuvant Montanide following specified schedule

Intervention Type: BIOLOGICAL

GM-CSF

subcutaneous injection

Intervention Type: BIOLOGICAL

Montanide

adjuvant

Intervention Type: OTHER

Other Intervention Names

GPS; SLS-001; sargramostim

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 > 50 k/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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: collaborator

Sellas Life Sciences Group

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Maslak, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 29386195 (View on PubMed)

Related Links

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

Memorial Sloan Kettering Cancer Center

Other Identifiers

10-143

Identifier Type: -

Identifier Source: org_study_id