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Treatment of the Acute Myeloblastic Leukaemia in Patients Over 65 Years

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ClinicalTrials.gov Identifier: NCT00464217
Recruitment Status : Completed
First Posted : April 23, 2007
Last Update Posted : January 5, 2010
Sponsor:
Information provided by:
PETHEMA Foundation

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

Condition or disease Intervention/treatment Phase
Acute Myeloblastic Leukaemia Drug: ARA-C Drug: Idarubicin Drug: Leucomax Phase 4

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)

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Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PETHEMA-LAM99:Treatment of the Acute Myeloblastic Leukaemia in Patients Over 65 Years
Study Start Date : October 1998
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008





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

Secondary Outcome Measures :
  1. Evaluate the toxicity
  2. Evaluate the effect of haematopoietic growth factors


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00464217


Locations
Show Show 24 study locations
Sponsors and Collaborators
PETHEMA Foundation
Investigators
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Principal Investigator: Garcia Laraña Jose, Dr Hospital Universitario Ramon y Cajal
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00464217    
Other Study ID Numbers: PETHEMA/LAM-99
First Posted: April 23, 2007    Key Record Dates
Last Update Posted: January 5, 2010
Last Verified: January 2010
Keywords provided by PETHEMA Foundation:
Acute Myeloblastic Leukaemia
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Idarubicin
Molgramostim
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action