Clinical trial · Interventional
WT1 Vaccine Treatment of Patients in Remission From Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL)
Phase 2 Trial of a WT1 Analog Peptide Vaccine in Patients in Complete Remission (CR) From Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL)
NCT01266083CI-TRIAL-00082682completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Galinpepimut-S | Biological | — | UNRESOLVED |
| GM-CSF | Biological | — | UNRESOLVED |
| Montanide | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Galinpepimut-S + Montanide + GM-CSF
- description
- 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.
- interventionNames
- Biological: Galinpepimut-S
- Biological: GM-CSF
- Other: Montanide
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- 3 years
- description
- OS at 3 years, measured from first treatment with GPS to patient's survival status at 3 years or more
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTMaslak 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