NCT00464217

Treatment of the Acute Myeloblastic Leukaemia in Patients Over 65 Years

PETHEMA-LAM99:Treatment of the Acute Myeloblastic Leukaemia in Patients Over 65 Years

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (planned)
• Sponsor: PETHEMA Foundation · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

To reproduce or to improve the index of complete responses of protocol LMA-91 with a similar protocol, decreasing the dose of Idarubicin to try to reduce the deaths in induction

Detailed description

INDUCTION TREATMENT :Ara-C 100 mg/m 2 /day in continuous perfusion,days 1 - 7. Idarubicin 8 mg/m 2 /day, days 1 - 3 in bolus. GM-CSF (Leucomax) 5 mcg/kg subcutaneous or endovenous from day + 4 after finishing the chemotherapy until the recovery of neutropenia (\> 1.000/mm 3) CONSOLIDATION TREATMENT The patients who reach a complete response with the first cycle, will receive a second cycle to consolidation. The patients who do not reach a complete response with the first cycle will receive a second cycle. If after two cycles,do not obtain the response, patient should leave the protocol. INTENSIFICATION TREATMENT All the patients who are in complete response after one cycle of induction and one cycle of consolidation, or after two cycles of induction, will receive a treatment of intensification with: ARA-C 500 mg/m 2 /12 h in one hour infusion, days 1-4. Daunomycin 45 mg/m 2 /day bolu, days 5-7. GM-CSF (Leucomax): 5 mcg/kg from day to + 4 after finishing the chemotherapy until the recovery of neutropenia (\>1.000/mm 3)

Conditions

• Acute Myeloblastic Leukaemia

Interventions

Type	Name	Description
DRUG	ARA-C
DRUG	Idarubicin
DRUG	Leucomax

Timeline

• Start date: 1998-10-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2007-04-23
• Last updated: 2010-01-05

Locations

24 sites across 1 country: Spain