Clinical trial · Interventional
Feasibility Study of Acute Myelogenous Leukemia mRNA Plus Lysate Loaded Dendritic Cell Vaccines
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Terminated early due to slow accrual.
Summary
Brief summary (as posted)
Primary Objectives: 1. To determine the feasibility of delivering autologous dendritic cells (DCs) loaded with acute myelogenous leukemia (AML) lysate plus messenger RNA (mRNA) to AML patients following consolidation therapy. 2. To determine the toxicity of autologous DCs loaded with AML lysate plus mRNA. 3. To quantitate immune responses in patients who receive autologous DCs loaded with AML lysate plus mRNA. Secondary Objectives: 1. To evaluate minimal residual disease following DC therapy using the polymerase chain reaction assay for the Wilm's Tumor-1 gene. 2. To asses the disease-free and overall survival of AML patients who receive the autologous DCs loaded with AML lysate plus mRNA.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous Dendritic Cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Autologous Dendritic Cells
- interventionNames
- Biological: Autologous Dendritic Cells
Primary outcomes (1)
- measure
- Time to Adverse Event (AE)
- timeFrame
- Day of First Vaccination to 6 Months Follow Up After Last Patient Accrued
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. Untreated AML except patients with inv (16), t(8;21), or t (15;17) cytogenetics or AML in first relapse. 2. Patients must have \>/= 2,000 circulating blasts/ul peripheral blood or \>/= 50% blasts in bone marrow biopsy 3. Performance Status 0-2 Exclusion Criteria: 1. Medical, social or psychological factors which would prevent the patient from receiving or cooperating with the full course of therapy or understanding the informed consent procedure. 2. Concurrent or expected need for therapy with corticosteroids during the vaccination phase of the study. 3. History of systemic autoimmune disease 4. Positive antibody to human immunodeficiency virus 5. Patients with Acute promyelocytic Leukemia are not eligible for this study. 6. Good-risk cytogenetics which are: (inv (16), t(8;21), or t (15;17) 7. Positive Beta HCG test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization
References
Publications (0)
Data not yet available