A Phase 4 interventional study of ARA-C and Idarubicin in Acute Myeloblastic Leukaemia, sponsored by PETHEMA Foundation. Completed at 24 sites in Spain. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2010-01-05.
Sponsored by PETHEMA Foundation · Phase 4, Interventional, and Treatment
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)
5,441 studies on the registry are indexed under Leukemia; 637 are open to participants now.
This study's enrollment of 100 is above the median of 38 across 4,248 interventional studies indexed under Leukemia.
Browse Leukemia studies →PETHEMA Foundation is the lead sponsor of 104 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
Improve the complete response index in patients diagnosed of acute myeloblastic leukaemia over 65 years
Evaluate the toxicity
Evaluate the effect of haematopoietic growth factors
This study is completed, as verified in Jan 2010. You cannot join it, but the record below documents what was studied.
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PETHEMA Foundation