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The present study aims to compare the efficacy of postremission maintenance therapy with 5-Aza versus best supportive care (BSC) in a cohort of AML patients aged >60 years, who have achieved complete remission (CR) following conventional induction ('3+7') and consolidation chemotherapy.
The present study aims to compare the efficacy of postremission maintenance therapy with 5-Aza versus best supportive care (BSC) in a cohort of AML patients aged >60 years, who have achieved CR following conventional induction ('3+7') and consolidation chemotherapy to evaluate 2 an 5 year post-remission rates of Overall Survival and disease free survival between two arms
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azacitidine | Experimental | Vidaza consists of 50 mg/ m2 s.c or i.v for 7 days (5 + weekend off + 2) every 28 days and increase after 1st cycle, if well tolerated, to 75 mg/m2 s.c or i.v. for 7 days (5 + weekend off + 2) every 28 days for further 5 cycles followed by cycles every 56 days for 4 years and six months |
|
| Best supportive care | Placebo Comparator | No drug administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vidaza 100 milligram (mg) injection | Drug | 1st cycle 50 mg/sqm s.c. or i.v. for 7 days (5 + weekend off + 2) every 28 days and increase dosing after 1st cycle, if well tolerated, to 75 mg/ m2 for further 5 cycles, followed by cycles every 56 days for 4 years and six months post-remission. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease free Survival (DFS) | Disease-free survival (DFS) at 2 and 5 years. Events for DFS are death and first relapse (either AML or myelodysplastic syndrome (MDS) recurrence) and death; observations are censored at the date of last contact if alive and disease-free. DFS will be calculated from the date of achievement of CR to the date of 1st relapse or death. Patients still alive in 1st CR will be censored at the moment of last visit/contact. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Hospitalizations | Number and length of hospitalizations in the post-remission period. | 5 years |
| Overall Survival (OS) | Overall survival (OS) at 2 and 5 years. Event for OS in both arms is death and patients are censored at the date of last contact if alive |
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Inclusion Criteria:
Age 61 years or more
Newly diagnosed AML with > 30% myeloid marrow blasts, either "de novo" or evolving from a MDS not previously treated with chemotherapeutic agents.
Absence of central nervous system involvement
No contraindications for intensive chemotherapy, defined as:
Informed consent.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Esther Natalie Oliva | QOL-ONE Associazione Culturale e di Ricerca | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| A.O. SS. Antonio e Biagio e Cesare Arrigo | Alessandria | AL | Italy | |||
| Ospedale Riuniti |
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|
|
| Best Supportive Care | Other | Best supportive care includes antibiotics, transfusions and fluids |
|
| 2 and 5 years |
| Ancona |
| AN |
| Italy |
| A.O. S. Giovanni Moscati | Avellino | AV | Italy |
| Policlinico UniversitĂ di Bari | Bari | BA | Italy |
| Ospedale L'Annunziata | Cosenza | CS | Italy |
| Ospedale Ferrarotto | Catania | CT | Italy |
| Ospedale Garibaldi | Catania | CT | Italy |
| Ospedale Casa Sollievo della Sofferenza | San Giovanni Rotondo | FG | Italy |
| UniversitĂ degli Studi di Genova | Genova | GE | Italy |
| IRCCS Ospedale Maggiore Policlinico | Milan | MI | Italy |
| Ospedale Civile Spirito Santo | Pescara | PE | Italy |
| Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli | Reggio Calabria | RC | 89100 | Italy |
| Ospedale Sant'Eugenio | Roma | RM | Italy |
| Policlinico Agostino Gemelli | Roma | RM | Italy |
| Azienda Ospedaliera Sant'Andrea | Rome | RM | Italy |
| IRCCS Istituto Regina Elena | Rome | RM | Italy |
| A.O.U. San Giovanni di Dio e Ruggì D'Aragona | Salerno | SA | Italy |
| A.O.U. di Udine Centro Trapianti e Terapie Cellulari | Udine | Italy |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D007267 | Injections |
| D001374 | Azacitidine |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
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