Clinical trial · Observational
Prospective Study on Severe Infections on Acute Myeloid Leukemia (AML) Patients
Prospective Survey on Severe Infections During a Multicenter Study of Risk-adapted, MRD-directed Therapy for Young Adults With Newly Diagnosed Acute Myeloid Leukemia.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): low interest
Summary
Brief summary (as posted)
All patients receiving induction, consolidation and salvage chemotherapy, and autologous or allogeneic stem cell transplantation according to a strategy defined in the GIMEMA AML1310 protocol will be prospectively monitored for SI (bacteremia, invasive mycoses, other microbiologically documented bacterial infections, pneumonia, other invasive tissue infections and viral diseases) during each chemotherapy and transplant and the impact of these infections on survival will be evaluated until 24 months from the diagnosis of AML.
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 |
|---|---|---|---|
| Adult | — | UNRESOLVED | — |
| AML | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Observation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- All patients enrolled in the GIMEMA AML1310 study.
- description
- * All patients enrolled in the GIMEMA AML1310 study; * Signed written informed consent according to ICH/EU/GCP and national local laws.
- interventionNames
- Other: Observation
Primary outcomes (1)
- measure
- Prognostic role on overall survival
- timeFrame
- At four years from study entry.
- description
- At 24 months of each type of Severe Infection (SI).
Secondary outcomes (8)
- measure
- Rate of incidence of SI.
- timeFrame
- At four years from study entry
- description
- Rate of incidence of SI during chemotherapy, transplantation procedures, and follow up of patients enrolled in the GIMEMA study AML1310
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * All patients enrolled in the GIMEMA AML1310 study; * Signed written informed consent according to ICH/EU/GCP and national local laws. Exclusion Criteria: * Patients not eligible for the GIMEMA AML1310 study.
References
Publications (0)
Data not yet available