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


Phase 4
65 Years
N/A
Not Enrolling
Both
Acute Myeloblastic Leukaemia

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Trial Information

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


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)


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Improve the complete response index in patients diagnosed of acute myeloblastic leukaemia over 65 years

Principal Investigator

Garcia Laraña Jose, Dr

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hospital Ramón y Cajal

Authority:

Spain: Ministry of Health

Study ID:

PETHEMA/LAM-99

NCT ID:

NCT00464217

Start Date:

October 1998

Completion Date:

December 2008

Related Keywords:

  • Acute Myeloblastic Leukaemia
  • Acute Myeloblastic Leukaemia
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

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