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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treated patients | hypomethylating agent (azacitidine or decitabine) in combination with venetoclax |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venetoclax | Drug | treatment with azacitidine or decitabine in combination with venetoclax |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete response (CR) rate | according to European Leukemia Network (ELN) | every three months after started treatment up to two years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) | according to European Leukemia Network (ELN) | every three months after started treatment up to two years |
| Morphologic leukemia-free state (MLFS) | according to European Leukemia Network (ELN) |
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Inclusion Criteria:
Exclusion Criteria:
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The study population includes adult patients with newly diagnosed acute myeloid leukemia not eligible for intensive chemotherapy, treated in a referral center for hematology
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francesco Zaja, Professor | Contact | +390403992888 | francesco.zaja@asugi.sanita.fvg.it |
| Name | Affiliation | Role |
|---|---|---|
| Francesco Zaja, Professor | SC Ematologia Ospedale Maggiore Trieste | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SC Ematologia Ospedale Maggiore | Recruiting | Trieste | 34100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20026804 | Background | Fenaux P, Mufti GJ, Hellstrom-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. | |
| 30361262 |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C579720 | venetoclax |
| D001374 | Azacitidine |
| D000077209 | Decitabine |
| ID | Term |
|---|---|
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| every three months after started treatment up to two years |
| Progression-free-survival | from start of the treatment to progression or death | from the start of the treatment until the date of documented progression or date of death from any cause, assessed up to 2 years |
| Overall survival | from start of the treatment to progression or death | from the start of the treatment until the date of documented progression or date of death from any cause, assessed up to 2 years |
| adverse events and serious adverse events | according to CTCAE v. 4.0 | through study completion, for an average of 1 year |
| Background |
| 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. |
| 27895058 | Result | Dohner H, Estey E, Grimwade D, Amadori S, Appelbaum FR, Buchner T, Dombret H, Ebert BL, Fenaux P, Larson RA, Levine RL, Lo-Coco F, Naoe T, Niederwieser D, Ossenkoppele GJ, Sanz M, Sierra J, Tallman MS, Tien HF, Wei AH, Lowenberg B, Bloomfield CD. Diagnosis and management of AML in adults: 2017 ELN recommendations from an international expert panel. Blood. 2017 Jan 26;129(4):424-447. doi: 10.1182/blood-2016-08-733196. Epub 2016 Nov 28. |
| 20668231 | Result | Kantarjian H, Ravandi F, O'Brien S, Cortes J, Faderl S, Garcia-Manero G, Jabbour E, Wierda W, Kadia T, Pierce S, Shan J, Keating M, Freireich EJ. Intensive chemotherapy does not benefit most older patients (age 70 years or older) with acute myeloid leukemia. Blood. 2010 Nov 25;116(22):4422-9. doi: 10.1182/blood-2010-03-276485. Epub 2010 Jul 28. |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |