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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00464217

Enrollment

100

Registered

2007-04-23

Start date

1998-10-31

Completion date

2008-12-31

Last updated

2010-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloblastic Leukaemia

Keywords

Acute Myeloblastic Leukaemia

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 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)

Interventions

DRUGARA-C

DRUGIdarubicin

DRUGLeucomax

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

Inclusion criteria

* Cytologic diagnosis of acute myeloblastic leukaemia (excluded M3) * Over 65 years

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
Improve the complete response index in patients diagnosed of acute myeloblastic leukaemia over 65 years	—

Secondary

Measure	Time frame
Evaluate the toxicity	—
Evaluate the effect of haematopoietic growth factors	—

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026