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NCT Number: NCT00464217

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

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Key information

Conditions

Acute Myeloblastic Leukaemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital General de Albacete, Albacete, Spain

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About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ara-C

Drug

Idarubicin

Drug

Leucomax

Drug

Primary outcomes

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

Secondary outcomes

  1. Evaluate the toxicity

  2. Evaluate the effect of haematopoietic growth factors

Sponsors and collaborators

Lead sponsor

PETHEMA Foundation

Other

Registry information

Official study title

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

Important dates

Study start
1998
Primary completion
2008
Study completion
2008
First posted
Apr 23, 2007
Registry last updated
Jan 5, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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