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Treatment of the Acute Myeloblastic Leukaemia in Patients Over 65 Years

This study has been completed.
Information provided by:
PETHEMA Foundation Identifier:
First received: April 20, 2007
Last updated: January 3, 2010
Last verified: January 2010
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 Intervention Phase
Acute Myeloblastic Leukaemia Drug: ARA-C Drug: Idarubicin Drug: Leucomax Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by PETHEMA Foundation:

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

Secondary Outcome Measures:
  • Evaluate the toxicity
  • Evaluate the effect of haematopoietic growth factors

Estimated Enrollment: 100
Study Start Date: October 1998
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
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)


Ages Eligible for Study:   65 Years and older   (Adult, Senior)
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00464217

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
Principal Investigator: Garcia Laraña Jose, Dr Hospital Universitario Ramon y Cajal
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00464217     History of Changes
Other Study ID Numbers: PETHEMA/LAM-99
Study First Received: April 20, 2007
Last Updated: January 3, 2010

Keywords provided by PETHEMA Foundation:
Acute Myeloblastic Leukaemia

Additional relevant MeSH terms:
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 processed this record on September 19, 2017