AML Treatment in Untreated Adult Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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AML Treatment in Untreated Adult Patients According to EORTC-GIMEMA Protocols AML8 and AML10

Conditions
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Leukemia, Myelocytic, Acute

Intervention / Treatment
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* Procedure: Identification of appropriate therapies according to risks factors
* Drug: Daunorubicine
* Procedure: Transplant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 61 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Identification of appropriate therapies according to risks factors|nan|
|Drug: Daunorubicine|nan|
|Procedure: Transplant|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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.