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Treatment of the Acute Myeloblastic Leukaemia in Patients Over 65 Years

This study has been completed.
Sponsor:
Information provided by:
PETHEMA Foundation
ClinicalTrials.gov Identifier:
NCT00464217
First received: April 20, 2007
Last updated: January 3, 2010
Last verified: January 2010
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

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)

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00464217

Locations
Spain
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 Universitario de Alcalá de Henares
Madrid, Spain
Hospital Clínico San Carlos
Madrid, Spain
Hospital Ramón y Cajal
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 Clínico
Valencia, Spain
Hospital Dr. Pesset
Valencia, Spain
Hospital Arnau de Vilanova
Valencia, Spain
Hospital Clínico
Valladolid, Spain
Hospital Virgen de la Concha
Zamora, Spain
Sponsors and Collaborators
PETHEMA Foundation
Investigators
Principal Investigator: Garcia Laraña Jose, Dr Hospital Ramón y Cajal
  More Information

Additional Information:
Spanish association of Haematology  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00464217     History of Changes
Other Study ID Numbers: PETHEMA/LAM-99
Study First Received: April 20, 2007
Last Updated: January 3, 2010
Health Authority: Spain: Ministry of Health

Keywords provided by PETHEMA Foundation:
Acute Myeloblastic Leukaemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Idarubicin
 Molgramostim
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013