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
NCT04589728 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 202
Last updated 2025-07-08
Summary
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
Interventions
- DRUG
-
Venetoclax plus HMA
patients with AML, ineligible for intensive chemotherapy, treated with the combination of HMA plus venetoclax under the Italian Law N. 648/96.
Sponsors & Collaborators
-
Gruppo Italiano Malattie EMatologiche dell'Adulto
lead OTHER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-02-23
- Primary Completion
- 2024-09-08
- Completion
- 2024-09-08
Countries
- Italy
Study Locations
More Related Trials
-
A Study of Pevonedistat and Venetoclax Combined With Azacitidine to Treat Acute Myeloid Leukemia (AML) in Adults Unable to Receive Intensive Chemotherapy
NCT04266795 ·Status: COMPLETED ·Phase: PHASE2
-
Venetoclax and Azacitidine for the Management of Molecular Relapse/Progression in Adult NPM1-mutated Acute Myeloid Leukemia
NCT04867928 ·Status: UNKNOWN ·Phase: PHASE2
-
Ivosidenib and Azacitidine With or Without Venetoclax in Adult Patients With Newly Diagnosed IDH1-Mutated AML or MDS/AML Considered Ineligible for Intensive Chemotherapy
NCT07075016 ·Status: RECRUITING ·Phase: PHASE3
-
A Phase 2 Study of Venetoclax in Combination With Low-dose HHT, G-CSF, and AZA as First-line Treatment for Newly Diagnosed Elderly AML Patients Unfit for Intensive Chemotherapy
NCT04824924 ·Status: UNKNOWN ·Phase: PHASE2
-
Safety and Efficacy of Venetoclax in Combination With Azacitidine and HA Regimen in the Treatment of AML in the Elderly
NCT05949762 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
AML Patients Bearing FLT3 Mutations Based on Peripheral Blast Clearance
NCT04174612 ·Status: UNKNOWN ·Phase: PHASE3
-
Observational Study on the Outcome of AML Patients Treated With New Drugs in Real-life (BoxTrial)
NCT06513273 ·Status: RECRUITING
-
Venetoclax and HMA Treatment of Older and Unfit Adults With FLT3 Mutated Acute Myeloid Leukemia (AML) (A MyeloMATCH Treatment Trial)
NCT06317649 ·Status: RECRUITING ·Phase: PHASE2
-
Safety and Efficacy of Venetoclax Combination With Decitabine(DEC3-VEN) in the Treatment of AML in the Adult
NCT06285136 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2/PHASE3
-
A Study to Assess Change in Disease State in Adult Participants With Acute Myeloid Leukemia (AML) Receiving Oral Venetoclax Tablets in Combination With Subcutaneously (SC) or Intravenously (IV) Injected Azacitidine in Colombia
NCT05587049 ·Status: RECRUITING
-
A Study of MBG453 in Combination With Azacitidine and Venetoclax in AML Patients Unfit for Chemotherapy
NCT04150029 ·Status: TERMINATED ·Phase: PHASE2
-
Clinical Study Protocol of Venetoclax Combined With Azacitidine and Harringtonine in the Treatment of sAML
NCT05513131 ·Status: UNKNOWN ·Phase: PHASE2
-
Bcl-2 Inhibitors Combined With Azacytidine and Chemotherapy in Elderly Patients With Previously Untreated AML
NCT05053425 ·Status: UNKNOWN ·Phase: NA
-
Venetoclax + Azacitidine vs. Induction Chemotherapy in AML
NCT04801797 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
De-Escalation Study Evaluating Venetoclax and Azacitidine Discontinuation in AML Responding Patients
NCT06557421 ·Status: RECRUITING ·Phase: PHASE2
-
Venetoclax in Combination With Standard Induction and Consolidation Chemotherapy in Newly Diagnosed Young AML Patients
NCT06162325 ·Status: ENROLLING_BY_INVITATION
-
Azacitidine in Combination With Low Dose Intensity Venetoclax in Patients With AML Incl. Explorative AML Profiling
NCT05431257 ·Status: RECRUITING ·Phase: PHASE2
-
Efficacy of Venetoclax Combined With Intensive Chemotherapy in Different Subgroups of AML
NCT06635681 ·Status: RECRUITING ·Phase: PHASE2
-
Daunorubicin + Cytarabine + Venetoclax in de Novo AML
NCT06697327 ·Status: ENROLLING_BY_INVITATION ·Phase: NA
-
Venetoclax+HMA+Aclarubicin Versus Venetoclax+HMA in Treatment-Naive Elderly Patients With AML
NCT05264883 ·Status: UNKNOWN ·Phase: PHASE3
-
Aza-Ven Followed by Reduced Toxicity Conditioning Regimen (MBF) as Salvage Therapy for Refractory AML.
NCT04904237 ·Status: UNKNOWN ·Phase: PHASE2
-
Reduced Intensive Idarubicin and Cytarabine Plus Venetoclax as First-line Treatment for Adults AML and MDS
NCT06050941 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Venetoclax-containing Therapy Combined With Microtransplant for Newly Diagnosed AML
NCT07078591 ·Status: RECRUITING ·Phase: PHASE2
-
Efficacy of Venetoclax Based Regimen in Prevention Relapse of Consecutive MRD Positive AML Patients
NCT05361057 ·Status: TERMINATED ·Phase: PHASE2
-
Hypomethylating Agent and Venetoclax After Allo-HSCT in Patients With High-risk Myeloid Malignancies.
NCT05841771 ·Status: RECRUITING ·Phase: PHASE2