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

NCT01266083 | Completed Phase 2 Results DMC

• 1 other identifier: 10-143
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia

Keywords

Galinpepimut-S; WT1 analog peptide vaccine; 10-143; Wilms Tumor-1 protein; SLS-001; complete remission; overall survival

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  OS at 3 years, measured from first treatment with GPS to patient's survival status at 3 years or more

  3 years

Secondary Outcomes (1)

• Progression-free Survival

  5 years and 8 months

Study Arms (1)

Galinpepimut-S + Montanide + GM-CSF

EXPERIMENTAL

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.

Biological: Galinpepimut-S; Biological: GM-CSF; Other: Montanide

Interventions

Galinpepimut-S BIOLOGICAL

Galinpepimut-S admixed with the adjuvant Montanide following specified schedule

Also known as: GPS, SLS-001

Galinpepimut-S + Montanide + GM-CSF

GM-CSF BIOLOGICAL

subcutaneous injection

Also known as: sargramostim

Galinpepimut-S + Montanide + GM-CSF

Montanide OTHER

adjuvant

Galinpepimut-S + Montanide + GM-CSF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sellas Life Sciences Group: lead
• Memorial Sloan Kettering Cancer Center: collaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Publications (1)

• 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.

  PMID: 29386195 RESULT

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Pathologic Complete Response

Interventions

Granulocyte-Macrophage Colony-Stimulating Factor; sargramostim; Monatide (IMS 3015)

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Dragan Cicic
• Organization: Sellas Life Sciences

info@sellaslife.com

646-200-5278

Study Officials

• Peter Maslak, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: December 21, 2010
• First Posted: December 24, 2010
• Study Start: January 14, 2011
• Primary Completion: September 30, 2016
• Study Completion: September 30, 2016
• Last Updated: November 19, 2024
• Results First Posted: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)