Clinical trial · Observational
Prospective and Retrospective Observational Evaluation of Real World Outcome of Unfit AML Patients Treated With the Combination Venetoclax Plus Hypomethylating Agents, Under the Italian Law No.648/96
Prospective and Retrospective Observational Evaluation of Real World Outcome of Unfit Patients With Acute Myeloid Leukemia Treated With the Combination Venetoclax Plus Hypomethylating Agents, Under the Italian Law No.648/96
- 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 an retrospective and prospective observational multinstitutional study to evaluate the impact on outcome of the combination of HMA plus venetoclax in AML patients unfit for intensive chemotherapy in a "real-life" scenario. No additional procedures or visits other than those required by normal clinical practice will be required. Patients will be observed for at least 24 months.
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 |
|---|---|---|---|
| Venetoclax plus HMA | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Study group
- description
- All patients being observed during the study duration.
- interventionNames
- Drug: Venetoclax plus HMA
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- 15 months
- description
- Evaluation of Overall Survival in AML patients ineligible for intensive chemotherapy treated with the combination of HMA plus Venetoclax
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients aged ≥ 18 years with a diagnosis of previously untreated primary or secondary AML; * Deemed ineligible for intensive chemotherapy because of age (≥75 years), performance status or comorbidities as defined by the treating physicians, according to SIE/SIES/GITMO criteria; * Eligible to receive the combination HMA plus venetoclax under the Italian Law No.648/96 by December 2021; * Signed written informed consent according to ICH/EU/GCP and national local laws. Exclusion Criteria: * Acute promyelocytic Leukemia; * Previous first-line treatments for AML; * Previous treatments with HMA.
References
Publications (0)
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