Hypomethylating Agents and Venetoclax in Newly Diagnosed Acute Myeloid Leukemia Patients Not Eligible for Intensive Chemotherapy
Study Details
Study Description
Brief Summary
This is a retrospective, observational, monocentric study to evaluate the efficacy and safety of the combination of an hypomethylating agent with venetoclax newly diagnosed patients with acute myeloid leukemia ineligible for intensive chemotherapy
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Detailed Description
The prognosis of acute myeloid leukemia (AML) patients who are ineligible for intensive chemotherapy is poor (Kantarjian et al). Hypomethylating agents, azacitidine and decitabine, are effective and less toxic regimens, and treatment with these agents has improved the prognosis of these patients (Fenaux et al).
Venetoclax, a Bcl-2 inhibitor, in combination with azacitidine has shown efficacy in AML patients with complete remission rate of 73% and overall survival at 2 years of 40-50% (Di Nardo et al).
On these grounds, the aim of this study is to collect the real-life experience with this combination in previously untreated AML patients.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| treated patients hypomethylating agent (azacitidine or decitabine) in combination with venetoclax |
Drug: Venetoclax
treatment with azacitidine or decitabine in combination with venetoclax
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Complete response (CR) rate [every three months after started treatment up to two years]
according to European Leukemia Network (ELN)
Secondary Outcome Measures
- Overall response rate (ORR) [every three months after started treatment up to two years]
according to European Leukemia Network (ELN)
- Morphologic leukemia-free state (MLFS) [every three months after started treatment up to two years]
according to European Leukemia Network (ELN)
- Progression-free-survival [from the start of the treatment until the date of documented progression or date of death from any cause, assessed up to 2 years]
from start of the treatment to progression or death
- Overall survival [from the start of the treatment until the date of documented progression or date of death from any cause, assessed up to 2 years]
from start of the treatment to progression or death
- adverse events and serious adverse events [through study completion, for an average of 1 year]
according to CTCAE v. 4.0
Eligibility Criteria
Criteria
Inclusion Criteria:
-
age ≥18 years
-
newly diagnosed acute myeloid leukemia not eligible for intensive chemotherapy
Exclusion Criteria:
-
promyelocytic acute myeloid leukemia
-
patients who have already received one or more prior lines of therapy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | SC Ematologia Ospedale Maggiore | Trieste | Italy | 34100 |
Sponsors and Collaborators
- Ospedale Maggiore Di Trieste
Investigators
- Principal Investigator: Francesco Zaja, Professor, SC Ematologia Ospedale Maggiore Trieste
Study Documents (Full-Text)
None provided.More Information
Publications
- DiNardo CD, Pratz K, Pullarkat V, Jonas BA, Arellano M, Becker PS, Frankfurt O, Konopleva M, Wei AH, Kantarjian HM, Xu T, Hong WJ, Chyla B, Potluri J, Pollyea DA, Letai A. Venetoclax combined with decitabine or azacitidine in treatment-naive, elderly patients with acute myeloid leukemia. Blood. 2019 Jan 3;133(1):7-17. doi: 10.1182/blood-2018-08-868752. Epub 2018 Oct 25.
- Fenaux P, Mufti GJ, Hellström-Lindberg E, Santini V, Gattermann N, Germing U, Sanz G, List AF, Gore S, Seymour JF, Dombret H, Backstrom J, Zimmerman L, McKenzie D, Beach CL, Silverman LR. Azacitidine prolongs overall survival compared with conventional care regimens in elderly patients with low bone marrow blast count acute myeloid leukemia. J Clin Oncol. 2010 Feb 1;28(4):562-9. doi: 10.1200/JCO.2009.23.8329. Epub 2009 Dec 21.
- HMA-V