Status:
COMPLETED
Treatment of the Acute Myeloblastic Leukaemia in Patients Over 65 Years
Lead Sponsor:
PETHEMA Foundation
Conditions:
Acute Myeloblastic Leukaemia
Eligibility:
All Genders
65+ years
Phase:
PHASE4
Brief 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 f...
Eligibility Criteria
Inclusion
- Cytologic diagnosis of acute myeloblastic leukaemia (excluded M3)
- Over 65 years
Exclusion
- Previous diagnosis of other malignancy hematopoietic disorder or myelodysplastic syndrome
- Previous treatment with antileucemic chemotherapy
- Psychiatric disorder
- Diagnosis of subtype FAB M3
- Creatinine \> 2.5 mg/dL
- Bilirubin , Alkaline Phosphatase or transaminases three times upper the limit
Key Trial Info
Start Date :
October 1 1998
Trial Type :
INTERVENTIONAL
End Date :
December 1 2008
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00464217
Start Date
October 1 1998
End Date
December 1 2008
Last Update
January 5 2010
Active Locations (24)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital General de Albacete
Albacete, Spain
2
Hospital Universitario
Alicante, Spain
3
Hospital Puerta del Mar
Cadiz, Spain
4
Hospital Ntra. Sra. del Rossell
Cartagena, Spain