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Treatment of the Acute Myeloblastic Leukaemia in Patients Over 65 Years

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00464217
Recruitment Status : Completed
First Posted : April 23, 2007
Last Update Posted : January 5, 2010
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

Information from the National Library of Medicine

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

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 identifier (NCT number): NCT00464217

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Hospital General de Albacete
Albacete, Spain
Hospital Universitario
Alicante, Spain
Hospital Ntra. Sra. del Rossell
Cartagena, Spain
Hospital General
Castellón, Spain
Hospital Puerta del Mar
Cádiz, Spain
Hospital de Galdacano
Galdacano, Spain
Hospital Ciudad de Jaén
Jaen, Spain
Hospital Insular de las Palmas
Las Palmas de Gran Canaria, Spain
Hospital Xeral
Lugo, Spain
Hospital Clínico San Carlos
Madrid, Spain
Hospital Ramón y Cajal
Madrid, Spain
Hospital Universitario de Alcalá de Henares
Madrid, Spain
Hospital Morales Messeguer
Murcia, Spain
Hospital Virgen de la Arrixaca
Murcia, Spain
Hospital Virgen de la Victoria
Málaga, Spain
Hospital Central de Asturias
Oviedo, Spain
Clínica Universitaria de Pamplona
Pamplona, Spain
Hospital Montecelo
Pontevedra, Spain
Hospital Clínico Universitario
Salamanca, Spain
Hospital Arnau de Vilanova
Valencia, Spain
Hospital Clínico
Valencia, Spain
Hospital Dr. Pesset
Valencia, Spain
Hospital Clínico
Valladolid, Spain
Hospital Virgen de la Concha
Zamora, Spain
Sponsors and Collaborators
PETHEMA Foundation
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Principal Investigator: Garcia Laraña Jose, Dr Hospital Universitario Ramon y Cajal

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00464217     History of Changes
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, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action