Clinical trial · Interventional
Vaccine Therapy and GM-CSF in Treating Patients With Acute Myeloid Leukemia in Remission
A Phase 3, Randomized, Double-Blind, Multicenter Study of Proteinase 3 PR1 Peptide Mixed With Montanide ISA-51 VG Adjuvant and Administered With GM-CSF in Elderly Patients With AML in First Complete Remission or Adults in Second Complete Remission: A Pivotal Study
- 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)
RATIONALE: Vaccines made from a peptide may help the body build an effective immune response to kill cancer cells. Colony-stimulating factors, such as GM-CSF, increase the number of white blood cells and platelets found in bone marrow or peripheral blood. Giving vaccine therapy together with GM-CSF may be an effective treatment for acute myeloid leukemia. It is not yet known whether giving vaccine therapy together with GM-CSF is more effective than giving placebo together with GM-CSF in treating acute myeloid leukemia. PURPOSE: This randomized phase III trial is studying vaccine therapy and GM-CSF to see how well they work compared with a placebo and GM-CSF in treating patients with acute myeloid leukemia in remission.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| placebo | Other | — | UNRESOLVED |
| PR1 leukemia peptide vaccine | Biological | — | UNRESOLVED |
| sargramostim | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive PR1 leukemia peptide vaccine and sargramostim (GM-CSF) subcutaneously.
- interventionNames
- Biological: PR1 leukemia peptide vaccine
- Biological: sargramostim
- type
- ACTIVE_COMPARATOR
- label
- Arm II
- description
- Patients receive placebo vaccine and GM-CSF subcutaneously.
- interventionNames
- Biological: sargramostim
- Other: placebo
Primary outcomes (1)
- measure
- Overall survival
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of acute myeloid leukemia (AML), defined by the presence of \> 20% blasts in marrow or blood, including the following subtypes:
* De novo AML, defined as AML with no clinical history of prior myelodysplastic syndromes (MDS) or myeloproliferative disorder (MPD) or exposure to potentially leukemogenic therapies or agents
* Secondary AML, defined as the following:
* AML secondary to prior existing MDS or MPD or development of AML secondary to proven leukemogenic exposure
* History of fatigue, bleeding, or recurrent infections preceding diagnosis of AML by ≥ 1 month with confirmation of existing peripheral blood film that demonstrates morphologic dysplasia
* In first complete remission (CR) (patients ≥ 55 years of age) OR second CR (patients ≥ 18 years of age) within the past month
* FAB stages M0-M2 and M4-M7 allowed if in first CR
* No acute promyelocytic leukemia in first CR
* FAB stages M0-M7 allowed if in second CR
* Marrow blast count \< 5% (≤ 200 nucleated cell count)
* No blasts in blood
* HLA-A2 positive at 1 allele
* No extramedullary disease
* No Auer rods
* No active meningeal or CNS leukemia
PATIENT CHARACTERISTICS:
* ECOG performance status 0-1
* Life expectancy must not be severely limited by other diseases
* Absolute neutrophil count \> 1,000/mm\^3
* Platelet count \> 100,000/mm\^3
* Bilirubin \< 2 mg/mL
* ALT \< 2 times upper limit of normal
* Creatinine ≤ 1.6 mg/mL
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Antineutrophil cytoplasmic antibody negative
* No serious medical condition, laboratory abnormality, or psychiatric illness that would preclude study compliance or increase risk to patient
* No other malignancy within the past 5 years except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix or breast
* No known allergy to incomplete Freund's adjuvant
* No hypercalcemia
* No progressive viral or bacterial infection
* Must be afebrile for 7 days without antibiotics
* No symptomatic cardiac disease
* LVEF ≥ 40%
* No symptomatic pulmonary disease
* FEV\_1, FVC, and DLCO ≥ 50% of predicated (without bronchodilator)
* No history of HIV positivity or AIDS
* No known hypersensitivity to sargramostim (GM-CSF), yeast-derived products, or any component of this product
* No history of Wegener's granulomatosis or vasculitis
PRIOR CONCURRENT THERAPY:
* Recovered from prior surgery and/or radiotherapy
* No prior allogeneic or syngeneic stem cell transplantation
* No prior solid organ transplantation
* No prior vaccine therapy for AML
* More than 28 days since prior chronic use (\> 2 weeks) of corticosteroids \> 10 mg/day (prednisone \[or equivalent\])
* Concurrent topical or inhaled corticosteroids allowed
* More than 3 months since prior experimental therapy, cyclosporine, or tacrolimus
* No concurrent radiotherapyReferences
Publications (0)
Data not yet available