Clinical trial · Interventional
DC Vaccination for Post-remission Therapy in AML
Dendritic Cell-based Active Immunotherapy of Patients With Acute Myeloid Leukemia Using Autologous Cells Transfected With RNA Encoding Two Different Leukemia-associated Antigens
NCT02405338CI-TRIAL-00045824completedPhase 1 / Phase 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 multi-centre, open label, prospective, non-randomized phase I/II trial in 20 patients including a safety-run in phase I part comprising 6 patients. Trial subjects will receive repeated immunotherapies with autologous Dendritic Cells (DCs), presenting two leukemia-associated antigens.
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 Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| WT1/PRAME vaccination | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- WT1/PRAME vaccination
- interventionNames
- Biological: WT1/PRAME vaccination
Primary outcomes (2)
- measure
- Percentage of patients in whom treatment with the scheduled number of immunotherapies is feasible
- timeFrame
- 2 years
- measure
- Percentage of grade I/II, grade III/IV and grade ≥III toxicities in patients having received at least 1 immunotherapy
- timeFrame
- 2 years
Secondary outcomes (6)
- measure
- Overall survival
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of Acute Myeloid Leukemia (AML) * Age 18 - 75 years * Morphologic remission (CR) with or without hematological recovery (CRi) following induction chemotherapy * WT1 with or without PRAME positivity by qPCR * Negative pregnancy test in women of childbearing potential (within 7 days before the first vaccination). Women of childbearing potential and sexually active male participants must use reliable methods of contraception during the whole treatment period and 3 months after the last trial drug dose * Negative HIV 1 and 2 test, Hepatitis B and C test and negative Syphilis test at screening * Informed consent signed prior to any trial related activities Exclusion Criteria: * Patients suitable for allogeneic stem cell transplantation * AML M3 (acute promyelocytic leukemia) * Patients not in complete remission (CR or CRi), bone marrow blast count ≥ 5 % * Active immunodeficiency syndromes * Concurrent active second malignancy other than non-melanoma skin cancers * Clinically relevant autoimmune disease * Prior immunotherapy * Severe organ dysfunction precluding the apheresis procedure: * Creatinine \> 200 mmol/l * Bilirubin, ALAT and ASAT \> 3 x upper normal limit * Respiratory insufficiency with pO2 \< 60 mmHg * Clinically relevant coronary heart disease of ventricular arrhythmia, congestive heart failure \> grade II NYHA * Recent cerebral hemorrhage * Known allergies to substances used in the generation of DCs * Other severe acute or chronic medical psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or the administration of the investigational product * Use of corticosteroids * Active CMV infection (Antibody-positivity due to previous, now inactive infection is accepted) * Inability to comply with the trial protocol * Participation in other clinical trials that, according to the investigator's discretion, may interfere with this trial
References
Publications (0)
Data not yet available
No reference posted for this study.