Efficacy of 5-Aza for Post-Remission Therapy of Acute Myeloid Leukemia (AML) in Elderly Patients
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 3 |
Detailed Description
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
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Azacitidine 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 |
Drug: Vidaza 100 milligram (mg) injection
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.
Other Names:
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Placebo Comparator: Best supportive care No drug administration |
Other: Best Supportive Care
Best supportive care includes antibiotics, transfusions and fluids
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Outcome Measures
Primary Outcome Measures
- Disease free Survival (DFS) [2 and 5 years]
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.
Secondary Outcome Measures
- Hospitalizations [5 years]
Number and length of hospitalizations in the post-remission period.
- Overall Survival (OS) [2 and 5 years]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 61 years or more
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Newly diagnosed AML with > 30% myeloid marrow blasts, either "de novo" or evolving from a MDS not previously treated with chemotherapeutic agents.
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Absence of central nervous system involvement
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No contraindications for intensive chemotherapy, defined as:
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prior congestive heart failure requiring treatment and/or left ventricular systolic ejection fraction below the normal range;
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a creatinine or bilirubin level more than twice the upper limit of normal, except if AML-related;
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a Performance Status (PS) score of > 2;
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uncontrolled severe infection.
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Informed consent.
Exclusion Criteria:
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Age ≤ 60 years
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Newly diagnosed AML with < 30% myeloid marrow blasts
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Previously treated AML
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Central nervous system involvement
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Prior congestive heart failure requiring treatment and/or left ventricular systolic ejection fraction below the normal range;
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A creatinine or bilirubin level more than twice the upper limit of normal, except if AML-related;
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A PS score of > 2;
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Uncontrolled severe infection.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | A.O. SS. Antonio e Biagio e Cesare Arrigo | Alessandria | AL | Italy | |
2 | Ospedale Riuniti | Ancona | AN | Italy | |
3 | A.O. S. Giovanni Moscati | Avellino | AV | Italy | |
4 | Policlinico Università di Bari | Bari | BA | Italy | |
5 | Ospedale L'Annunziata | Cosenza | CS | Italy | |
6 | Ospedale Ferrarotto | Catania | CT | Italy | |
7 | Ospedale Garibaldi | Catania | CT | Italy | |
8 | Ospedale Casa Sollievo della Sofferenza | San Giovanni Rotondo | FG | Italy | |
9 | Università degli Studi di Genova | Genova | GE | Italy | |
10 | IRCCS Ospedale Maggiore Policlinico | Milano | MI | Italy | |
11 | Ospedale Civile Spirito Santo | Pescara | PE | Italy | |
12 | Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli | Reggio Calabria | RC | Italy | 89100 |
13 | Ospedale Sant'Eugenio | Roma | RM | Italy | |
14 | Policlinico Agostino Gemelli | Roma | RM | Italy | |
15 | Azienda Ospedaliera Sant'Andrea | Rome | RM | Italy | |
16 | IRCCS Istituto Regina Elena | Rome | RM | Italy | |
17 | A.O.U. San Giovanni di Dio e Ruggì D'Aragona | Salerno | SA | Italy | |
18 | A.O.U. di Udine Centro Trapianti e Terapie Cellulari | Udine | Italy |
Sponsors and Collaborators
- Associazione Qol-one
Investigators
- Study Chair: Esther Natalie Oliva, QOL-ONE Associazione Culturale e di Ricerca
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- QOLESS-AZA-AMLE