Clinical trial · Interventional
A Study of Active Immunotherapy With GRNVAC1 in Patients With Acute Myelogenous Leukemia (AML)
A Phase II Study of Active Immunotherapy With GRNVAC1, Autologous Mature Dendritic Cells Transfected With mRNA Encoding Human Telomerase Reverse Transcriptase, in Patients With Acute Myelogenous Leukemia in Complete Clinical Remission
NCT00510133CI-TRIAL-00039394completedPhase 2ClinicalTrials.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 is a phase II study to evaluate the safety, feasibility and efficacy of immunotherapy with GRNVAC1 in patients with AML.
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 |
|---|---|---|---|
| Acute Myelogenous Leukemia | Acute Myeloid Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GRNVAC1 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- GRNVAC1
- description
- Autologous dendritic cell vaccine
- interventionNames
- Biological: GRNVAC1
Primary outcomes (1)
- measure
- Feasibility will be assessed by examining whether enough cells are collected during leukapheresis, whether enough vaccine is manufactured for at least 2 injections, and whether the patient is still in remission when the vaccine is released.
- timeFrame
- 1 year
Secondary outcomes (1)
- measure
- Immunological response, defined as the proportion of patients with a positive induction of hTERT-specific T cells to twice the pre-vaccination level, the proportion of patients with DTH, and event-free survival.
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * AML in first complete remission (CR1) or in second complete remission (CR2) with CR1 \>/= 6 months * Has completed at least one cycle of consolidation chemotherapy within past 6 months * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Adequate hepatic/renal function Exclusion Criteria: * CR1 and good risk cytogenetic features \[t(15;17), t(8;21), inv(16) or t(16:16)\] * Central nervous system or leptomeningeal disease * Allogeneic stem cell transplant planned or expected * Documented allergy to penicillin or beta-lactam antibiotics * Active or ongoing autoimmune disease * Clinically significant pulmonary or cardiovascular disease
References
Publications (0)
Data not yet available
No reference posted for this study.