NCT00390715

Treatment of Acute Myeloblastic Leukemia in Younger Patients

Prospective Study of the Value of the Cytogenetic and of the Monitoring of the Minimal Residual Disease

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: PETHEMA Foundation · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

study of the value of the cytogenetics and the monitoring of the residual minimum disease in the standard treatment of acute myeloblastic leukemia.

Detailed description

The treatment scheme is purely welfare and therefore it does not require any approval of ethical committees for his application. It gathers the basic ideas of the present treatment of the AML, with optional induction according to preference of each center with daunorubicin or Idarubicin (x3) associated to AraC (x7). The patients who reach CR consolidate with an identical cycle to the used one in the induction. Later (if pte has identical donor HLA, and as much it as their doctors has preference by this option) receive allogenic transplant. The other patients who reach CR receive two intensifications, one that AraC to intermediate dose contains and another one with autologous transplant, previous preparation with Busulfán, Etoposide and AraC. Later all antileucemic treatment is suspended until possible relapse. This scheme of treatment is accompanied by a valuation of the quality of the CR with traditional morphology, Immunocytometry and molecular genetic study and of a pursuit of residual minimum disease (EMR) using the same techniques.

Conditions

• Acute Myeloblastic Leukemia

Interventions

Type	Name	Description
DRUG	chemotherapy

Timeline

• Start date: 1999-01-01
• Primary completion: 2007-12-01
• Completion: 2010-01-01
• First posted: 2006-10-20
• Last updated: 2010-03-15

Locations

42 sites across 1 country: Spain