Clinical trial NCT00449319: AML Treatment in Untreated Adult Patients
Official title: AML Treatment in Untreated Adult Patients According to EORTC-GIMEMA Protocols AML8 and AML10
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Leukemia, Myelocytic, Acute
Keywords: AML
adult
Hydroxyurea
Transplant
Toevaluate biological characteristics at diagnosis.
To identify genetic alterations with prognostic relevance.
To follow up cases monitoring minimal disease during remission.
To evaluate pretreatment therapy in terms of response rate and toxicity.
Disease free survival.
Overal survival.
Lead sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
Sponsor class: OTHER
First posted: 2007-03-20
Sex: ALL
Minimum age (years): 15
Maximum age (years): 61
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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 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.

Eligibility criteria: Inclusion Criteria:

* AML "de novo" with bone marrow blasts \<=30%
* Performance status: 0-3
* FAB subtype: all except M3
* Written informed consent

Exclusion Criteria:

* age \<15 years and \>= 61 years
* pretreated AML with chemiotherapy (except Idrossiurea) or radiotherapy or corticosteroids for more than 7 days.
* diagnosis of acute promyelocitic leukemia (M3)
* Performance status = 4
* Uncontrolled infection

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Gallarate
country: Italy
facility: Prof. Mozzana
city: Latina
country: Italy
facility: Dr. De Blasio
city: Lodi
country: Italy
facility: Prof. Nalli
city: Milano
country: Italy
facility: Prof. Bordigon
city: Napoli
country: Italy
facility: Dr Miraglia
city: Napoli
country: Italy
facility: Dr. Mettivier
city: Napoli
country: Italy
facility: Dr.ssa Mastrullo
city: Napoli
country: Italy
facility: Prof. Pane
city: Nocera Inferiore
country: Italy
facility: Prof. D'Arco
city: Novara
country: Italy
facility: Dr Avanzi
city: Nuoro
country: Italy
facility: Dr. Gabbas
city: Orbassano
country: Italy
facility: Prof. Saglio
city: Palermo
country: Italy
facility: Dr Mirto
city: Palermo
country: Italy
facility: Prof. Citarrella
city: Palermo
country: Italy
facility: Prof. Mariani
city: Parma
country: Italy
facility: Prof. Rizzoli
city: Perugia
country: Italy
facility: Pr. Mecucci
city: Perugia
country: Italy
facility: Prof. Falini
city: Perugia
country: Italy
facility: Prof. Martelli
city: Pescara
country: Italy
facility: Dr. Fioritoni
city: Pisa
country: Italy
facility: Pr. Petrini
city: Potenza
country: Italy
facility: Dr. Ricciuti
city: Reggio Calabria
country: Italy
facility: Dr. Nobile
city: Roma
country: Italy
facility: Dr. Andriani
city: Roma
country: Italy
facility: Dr. Majolino
city: Roma
country: Italy
facility: Pr. Amadori
city: Roma
country: Italy
facility: Pr. Annino
city: Roma
country: Italy
facility: Pr. Leone
city: Roma
country: Italy
facility: Pr. Lo Coco
city: Rozzano
country: Italy
facility: Dr. Santoro
city: San Giovanni Rotondo
country: Italy
facility: Pr. Carella
city: Sassari
country: Italy
facility: Pr. Longinotti
city: Sondalo
country: Italy
facility: Dr Epis
city: Taormina
country: Italy
facility: Dr. Russo
city: Taranto
country: Italy
facility: Dr Mazza
city: Torino
country: Italy
facility: Pr. Boccadoro
Study officials:
affiliation: Gruppo Italiano Malattie EMatologiche dell'Adulto
name: Franco MANDELLI, Pr.
role: PRINCIPAL_INVESTIGATOR
References: