Clinical trial · Observational
RWE of 1st Line Treatment in Adults With AML From 18 to 70 Years Old.
Real World Evidence of First Line Treatment With Intensive Chemotherapy in Adult Patients With Acute Myeloid Leukemia From 18 to 70 Years Old
NCT05127798CI-TRIAL-00055138unknownClinicalTrials.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, observational real world clinical trial with prospective follow up that will evaluate the treatment outcome of Acute Myeloid Leukemia (AML) patients in the first line with intensive chemotherapy based regimens in Argentina.
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, Adult | Adult Acute Myeloid Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Evaluation of first line treatment with intensive treatment outcome in adult patients with AML. | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Adult from 18 to 70 years old AML in first line
- description
- Patients \>/= 18 years old with recent diagnosis of AML who receive treatment with intensive chemotherapy according to our local guidelines.
- interventionNames
- Other: Evaluation of first line treatment with intensive treatment outcome in adult patients with AML.
Primary outcomes (2)
- measure
- Evaluate the Overall Survival of patients diagnosed with primary or secondary AML between 18 and 70 years of age treated in first line with intensive chemotherapy regimens and risk-adapted consolidation.
- timeFrame
- 36 months
- description
- Evaluate overall survival of patients diagnosed with AML and treated in first line with intensive chemotherapy combined with different consolidation modalities depending on risk category
- measure
- Evaluate the Event Free Survival of patients diagnosed with primary or secondary AML between 18 and 70 years of age treated in first line with intensive chemotherapy regimens and risk-adapted consolidation.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Patients 18 years or older. * Patients with AML (de novo or secondary to MDS or previous treatment) who meet the diagnostic criteria according to WHO 2016 classification. * Signature of the form consent for participation in the study. Exclusion Criteria: * Men and women, \<18 or \>70 years of age. * Patients with chronic myeloid leukemia blast crisis or transformation to acute leukemia of other myeloproliferative syndromes. * Patients with relapsed AML. * Acute promyelocytic leukemia t(15; 17) or variants. * Absence of written informed consent. * Eastern Cooperative Oncology Group (ECOG) performance status ≥ 3 that is not due to the disease that motivates the treatment (AML). * Transplant Comorbidity Index (HCT-CI) \>3. * Left ventricular ejection fraction \< 40% by echocardiogram (Simpsom). * Bilirubin, alkaline phosphatase or alanine aminotransferase \> 3 times the upper normal limit not due to AML. * Serum creatinine ≥ 2.5 mg/dL not due to AML. * Positive pregnancy test or absence of effective methods of contraception in women of childbearing age. * Presence of active neoplasia other than AML whose treatment is more urgent at the discretion of the treating physicians. * Presence of serious psychiatric illness. * Known history of infection with human immunodeficiency virus (HIV). Active uncontrolled Hepatitis C or Active uncontrolled Hepatitis B. * Any other condition, such as age or associated pathology that contraindicates treatment with intensive chemotherapy, especially with anthracyclines. Any patient who does not meet the inclusion and exclusion criteria for treatment with intensive chemotherapy may be evaluated on an individual basis if it is considered that they could still benefit from this treatment.
References
Publications (0)
Data not yet available
No reference posted for this study.