Last updated on February 2018

AML Treatment in Untreated Adult Patients


Brief description of study

The present therapy intends to be an homogeneous treatment for AML patients based on a pretreatment with hydroxiurea plus an induction therapy with the standard arm with Daunorubicine as according to EORTC-GIMEMA AML10 study.

The post-remissional treatment is based on transplant with HLA compatible donor is foreseen for all patients and autologous transplant for those without HLA compatible donor available.

Detailed Study Description

GIMEMA treatment for adult (15-60 yrs) AML patients included a 3-drug induction cycle with DNR (50 mg/m2 d 1, 3, 5), cytarabine (100 mg/m2 d1-10), etoposide (100 mg/m2 d1-5) followed by an intensive consolidation with cytarabine (500 mg/m2/q12 hrs d1-d6) and the same anthracycline as in induction on d 4-6. Following consolidation, eligible pts (age <45 or 55 yrs) with a HLA compatible sibling had to be allografted, the others, had to be autografted with autologous peripheral stem cell (PSC) collected during recovery from consolidation.

BM and PB samples at diagnosis were centralized according to a national GIMEMA original study planned with the aim to accurately evaluate biological characteristics at diagnosis and to identify genetic alterations with prognostic relevance and to follow up cases monitoring minimal disease during remission. To allow the adequate collection and sending of samples before starting intensive chemotherapy, all patients received a 5-day pretreatment consisting of hydroxiurea (HU) at the dosage of 2 g/m2/day, also effective for "debulkying" of disease.

Clinical Study Identifier: NCT00449319

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Marco VIGNETTI, Dr

Prof. Mozzana
Gallarate, Italy
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Marco VIGNETTI, Dr

Dr. De Blasio
Latina, Italy
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Marco VIGNETTI, Dr

Prof. Nalli
Lodi, Italy
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Marco VIGNETTI, Dr

Prof. Bordigon
Milano, Italy
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Marco VIGNETTI, Dr

Dr Miraglia
Napoli, Italy
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Marco VIGNETTI, Dr

Dr. Mettivier
Napoli, Italy
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Marco VIGNETTI, Dr

Dr.ssa Mastrullo
Napoli, Italy
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Marco VIGNETTI, Dr

Prof. Pane
Napoli, Italy
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Marco VIGNETTI, Dr

Prof. D'Arco
Nocera Inferiore, Italy
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Marco VIGNETTI, Dr

Dr Avanzi
Novara, Italy
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Marco VIGNETTI, Dr

Dr. Gabbas
Nuoro, Italy
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Marco VIGNETTI, Dr

Prof. Saglio
Orbassano, Italy
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Marco VIGNETTI, Dr

Dr Mirto
Palermo, Italy
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Marco VIGNETTI, Dr

Prof. Citarrella
Palermo, Italy
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Marco VIGNETTI, Dr

Prof. Mariani
Palermo, Italy
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Marco VIGNETTI, Dr

Prof. Rizzoli
Parma, Italy
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Marco VIGNETTI, Dr

Pr. Mecucci
Perugia, Italy
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Marco VIGNETTI, Dr

Prof. Falini
Perugia, Italy
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Marco VIGNETTI, Dr

Prof. Martelli
Perugia, Italy
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Marco VIGNETTI, Dr

Dr. Fioritoni
Pescara, Italy
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Marco VIGNETTI, Dr

Pr. Petrini
Pisa, Italy
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Marco VIGNETTI, Dr

Dr. Ricciuti
Potenza, Italy
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Marco VIGNETTI, Dr

Dr. Nobile
Reggio Calabria, Italy
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Marco VIGNETTI, Dr

Dr. Andriani
Roma, Italy
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Marco VIGNETTI, Dr

Dr. Majolino
Roma, Italy
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Marco VIGNETTI, Dr

Pr. Amadori
Roma, Italy
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Marco VIGNETTI, Dr

Pr. Annino
Roma, Italy
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Marco VIGNETTI, Dr

Pr. Leone
Roma, Italy
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Marco VIGNETTI, Dr

Pr. Lo Coco
Roma, Italy
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Marco VIGNETTI, Dr

Dr. Santoro
Rozzano, Italy
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Marco VIGNETTI, Dr

Pr. Carella
San Giovanni Rotondo, Italy
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Marco VIGNETTI, Dr

Pr. Longinotti
Sassari, Italy
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Marco VIGNETTI, Dr

Dr Epis
Sondalo, Italy
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Marco VIGNETTI, Dr

Dr. Russo
Taormina, Italy
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Marco VIGNETTI, Dr

Dr Mazza
Taranto, Italy
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Marco VIGNETTI, Dr

Pr. Boccadoro
Torino, Italy
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Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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