NCT00449319

AML Treatment in Untreated Adult Patients

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: —
• Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto · Academic / Other
• Sex: All
• Age: 15 Years – 61 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Leukemia, Myelocytic, Acute

Interventions

Type	Name	Description
PROCEDURE	Identification of appropriate therapies according to risks factors
DRUG	Daunorubicine
PROCEDURE	Transplant

Timeline

• Start date: 1998-11-01
• Primary completion: 2018-06-01
• Completion: 2018-07-01
• First posted: 2007-03-20
• Last updated: 2017-11-17

Locations

36 sites across 1 country: Italy