Clinical trial · Interventional
Study of Vaccination With Autologous Acute Myeloblastic Leukemia Cells in Patients With Advanced Myelodysplasia or Acute Myelogenous Leukemia
A Phase I Study of Vaccination With Lethally Irradiated, Autologous Acute Myeloblastic Leukemia Cells Engineered by Adenoviral Mediated Gene Transfer to Secrete Human Granulocyte-Macrophage Colony Stimulating Factor in Patients With Advanced Myelodysplasia or Acute Myelogenous Leukemia
- 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)
The purpose of this study is to test the safety of a new investigational acute myeloblastic leukemia (AML) vaccine and see what effects (good and bad) it has on patients with advanced myelodysplasia or acute myelogenous leukemia.
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 Myelogenous Leukemia | Acute Myeloid Leukemia | ALIAS | 0.90 |
| Myelodysplasia | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| autologous tumor cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To determine the feasibility of preparing lethally irradiated autologous myeloblastic leukemia cells engineered by adenoviral mediated gene transfer to secrete GM-CSF in patients with myelodysplastic syndromes (MDS) or AML
Secondary outcomes (1)
- measure
- To determine the safety and biologic activity of vaccination with lethally irradiated, autologous myeloblastic leukemia cells engineered by adenoviral mediated gene transfer to secrete GM-CSF in patients with MDS or AML
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have pathologically documented myelodysplasia or acute myelogenous leukemia. * The patients with myelodysplasia must also have: French-American-British (FAB) subtype refractory anemia with excess blasts (RAEB) or refractory anemia with excess blasts in transformation (RAEB-T), or normal or hypercellular bone marrow. * The patients with acute myelogenous leukemia must also: not be candidates for myelosuppressive chemotherapy due to age or comorbid disease, or have relapsed acute myelogenous leukemia or be refractory to standard therapy and not likely to require cytoreductive therapy within 60 days * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. * Estimated life expectancy of 6 months or greater. * Age at least 18 years. * Greater than 4 weeks from any chemotherapy, radiotherapy, immunotherapy, or systemic glucocorticoid therapy (non-glucocorticoid hormonal therapy allowed). * Greater than 2 months following bone marrow or peripheral blood stem cell transplantation or treatment with donor lymphocyte infusion (DLI). Exclusion Criteria: * Uncontrolled active infection. * Pregnancy or nursing mothers. * Previous participation in an adenovirus based trial. * The patients with myelodysplasia who have either: FAB subtype refractory anemia (RA), refractory anemia with ringed sideroblasts (RARS), chronic myelomonocytic leukemia (CMML), or the presence of hypocellular bone marrow. * Chemotherapy, radiotherapy, immunotherapy, or systemic steroid therapy within the last 4 weeks. * Active central nervous system (CNS) disease. * Evidence of infection with the human immunodeficiency virus. * Active psychiatric or mental illness making informed consent or careful clinical follow-up unlikely.
References
Publications (0)
Data not yet available