Clinical trial NCT00464217: Treatment of the Acute Myeloblastic Leukaemia in Patients Over 65 Years
Official title: PETHEMA-LAM99:Treatment of the Acute Myeloblastic Leukaemia in Patients Over 65 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Myeloblastic Leukaemia
Keywords: Acute Myeloblastic Leukaemia
Lead sponsor: PETHEMA Foundation
Sponsor class: OTHER
First posted: 2007-04-23
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Improve the complete response index in patients diagnosed of acute myeloblastic leukaemia over 65 years
Secondary outcomes:
measure: Evaluate the toxicity
measure: Evaluate the effect of haematopoietic growth factors
Other outcomes:
Locations:
city: Albacete
country: Spain
facility: Hospital General de Albacete
city: Alicante
country: Spain
facility: Hospital Universitario
city: Cartagena
country: Spain
facility: Hospital Ntra. Sra. del Rossell
city: Castellón
country: Spain
facility: Hospital General
city: Cádiz
country: Spain
facility: Hospital Puerta del Mar
city: Galdacano
country: Spain
facility: Hospital de Galdacano
city: Jaen
country: Spain
facility: Hospital Ciudad de Jaén
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Insular de las Palmas
city: Lugo
country: Spain
facility: Hospital Xeral
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario de Alcalá de Henares
city: Murcia
country: Spain
facility: Hospital Morales Messeguer
city: Murcia
country: Spain
facility: Hospital Virgen de la Arrixaca
city: Málaga
country: Spain
facility: Hospital Virgen de la Victoria
city: Oviedo
country: Spain
facility: Hospital Central de Asturias
city: Pamplona
country: Spain
facility: Clínica Universitaria de Pamplona
city: Pontevedra
country: Spain
facility: Hospital Montecelo
city: Salamanca
country: Spain
facility: Hospital Clínico Universitario
city: Valencia
country: Spain
facility: Hospital Arnau de Vilanova
city: Valencia
country: Spain
facility: Hospital Clínico
city: Valencia
country: Spain
facility: Hospital Dr. Pesset
city: Valladolid
country: Spain
facility: Hospital Clínico
city: Zamora
country: Spain
facility: Hospital Virgen de la Concha
Study officials:
affiliation: Hospital Universitario Ramon y Cajal
name: Garcia Laraña Jose, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.