Clinical trial · Observational
Prospective Non-interventional Study of Adult Patients With Acute Myeloid Leukemia (AML)
A Prospective Non-interventional Study Documenting the Management and Outcomes of Adult Patients With Acute Myeloid Leukemia (AML)
NCT04777916CI-TRIAL-00096266ALFAPPPrecruitingClinicalTrials.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)
During the last fifteen years, the landscape of AML diagnosis and therapeutical options has markedly evolved. Refined genetic and prognostic characterizations, together with new drug approvals and new allogeneic hematopoietic stem cell transplantation (HSCT) procedures, have increased patient journey diversity.
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 (AML) | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (5)
- label
- Standard intensive 3+7 YOUNG OR ELDERLY
- description
- Standard intensive 3+7 (anthracycline + cytarabine) chemotherapy ± an approved FLT3 inhibitor (midostaurine, Rydapt® or ± quizartinib, Vanflyta®), according to different dose schedules in older versus younger patients
- label
- GO, (Mylotarg®) with 3+7
- description
- Combination of sequential gemtuzumab ozogamicin (GO, Mylotarg®) with 3+7
- label
- CPX-351, (Vyxeos®)
- description
- Liposomal formulation of daunorubicin + cytarabine (CPX-351, Vyxeos®)
- label
- Less intensive chemotherapy with azacytidine combined or not with venetoclax; LDAC; ivosidenib
- description
- Less intensive chemotherapy with azacytidine either combined or not with venetoclax or low dose cytarabine (LDAC) or in AML bearing an IDH1 somatic mutation, with ivosidenib in newly diagnosed patients considered as not eligible for the more intensive options above
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient aged 18 years old or more * Patient with newly diagnosed previously untreated de novo, secondary or therapy-related AML * Patients with R/R de novo, secondary or therapy-related AML * Patient with Health insurance Exclusion Criteria: * Acute promyelocytic leukemia * AML which is not morphologically proven (patients with granulocytic sarcoma may be included) * For newly diagnosed AML: previous treatment of leukemia apart from hydroxyurea. Previous anti leukemia treatments are allowed if they were administered before the diagnosis of AML to treat a MDS, MPN, MPN/MDS or CML * Patient weighting less than 50 kgs * Opposition of the patient to participate to this non-interventional study More specific eligibility criteria might be requested to enter some study modules
References
Publications (0)
Data not yet available
No reference posted for this study.