Acute Myeloblastic Leukaemia Clinical Trial
Official title:
PETHEMA-LAM99:Treatment of the Acute Myeloblastic Leukaemia in Patients Over 65 Years
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
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)
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00840346 -
Panobinostat in Combination With Idarubicin and Cytarabine in Patients Aged 65 Years or Older With Newly Diagnosed Acute Myeloblastic Leukaemia (AML)
|
Phase 1/Phase 2 |