Treatment of the Acute Myeloblastic Leukaemia in Patients Over 65 Years
NCT ID: NCT00464217
Last Updated: 2010-01-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
100 participants
INTERVENTIONAL
1998-10-31
2008-12-31
Brief Summary
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Detailed Description
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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)
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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ARA-C
Idarubicin
Leucomax
Eligibility Criteria
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Inclusion Criteria
* Over 65 years
Exclusion Criteria
* 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
65 Years
ALL
No
Sponsors
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PETHEMA Foundation
OTHER
Principal Investigators
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Garcia Laraña Jose, Dr
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Ramon y Cajal
Locations
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Hospital General de Albacete
Albacete, , Spain
Hospital Universitario
Alicante, , Spain
Hospital Puerta del Mar
Cadiz, , Spain
Hospital Ntra. Sra. del Rossell
Cartagena, , Spain
Hospital General
Castellon, , Spain
Hospital de Galdacano
Galdakao, , Spain
Hospital Ciudad de Jaén
Jaén, , 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 Virgen de la Victoria
Málaga, , Spain
Hospital Morales Messeguer
Murcia, , Spain
Hospital Virgen de la Arrixaca
Murcia, , 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
Countries
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References
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Martinez-Lopez J, Fernandez-Redondo E, Garcia-Sanz R, Montalban MA, Martinez-Sanchez P, Pavia B, Mateos MV, Rosinol L, Martin M, Ayala R, Martinez R, Blanchard MJ, Alegre A, Besalduch J, Bargay J, Hernandez MT, Sarasquete ME, Sanchez-Godoy P, Fernandez M, Blade J, San Miguel JF, Lahuerta JJ; GEM (Grupo Espanol Multidisciplinar de Melanoma)/PETHEMA (Programa para el Estudio de la Terapeutica en Hemopatias Malignas) cooperative study group. Clinical applicability and prognostic significance of molecular response assessed by fluorescent-PCR of immunoglobulin genes in multiple myeloma. Results from a GEM/PETHEMA study. Br J Haematol. 2013 Dec;163(5):581-9. doi: 10.1111/bjh.12576. Epub 2013 Oct 3.
Related Links
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Spanish association of Haematology
Other Identifiers
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PETHEMA/LAM-99
Identifier Type: -
Identifier Source: org_study_id
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