Clinical trial · Observational
Exploring Disease Immunogenicity and the Immunological Effects of Hypomethylating Agents in Acute Myeloid Leukemia
NCT03789981CI-TRIAL-00080936Immune-AMLactive not recruitingClinicalTrials.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 multicenter, prospective, translational study, to evaluate the immunogenic profile of AML cases according to immune checkpoint molecule expression.
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 |
|---|---|---|---|
| Immunogenic profile | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- At diagnosis
- description
- Immunogenic profile in patients affected by primary or secondary AML at diagnosis
- interventionNames
- Genetic: Immunogenic profile
- label
- At relapse
- description
- Immunogenic profile in patients affected by primary or secondary AML at relapse
- interventionNames
- Genetic: Immunogenic profile
Primary outcomes (1)
- measure
- Evaluation of the Immunogenic profile of primary or secondary AML patients in according to the variations in expression of molecules involved in immune checkpoint
- timeFrame
- up to 30 months
- description
- The immunogenic profile of AML cases obtained by NeoAgprediction will be related with established biological and clinical parameters (including karyotype, percentage of blasts, clinical outcome) performing RNA sequencing (RNAseq) and whole exome sequencing (WES) analysis
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with new diagnosis of primary or secondary AML candidate to first line treatment with hypomethylating agents (specific for Cohort 1) Patients with primary or secondary AML who relapse after/during first line treatment with hypomethylating agents (specific for Cohort 2) for each cohort: 2. Participant is willing and able to give informed consent for participation in the study 3. Male or Female, aged \>18 years 4. Availability of clinical data Exclusion Criteria: 1. Age \< 18 years 2. AML M3 subtype according to FAB classification
References
Publications (0)
Data not yet available
No reference posted for this study.