Treatment of the Acute Myeloblastic Leukaemia in Patients Over 65 Years

Acute Myeloblastic Leukaemia Clinical Trial

Official title:

PETHEMA-LAM99:Treatment of the Acute Myeloblastic Leukaemia in Patients Over 65 Years

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00464217
• Other study ID #: PETHEMA/LAM-99
• Status: Completed
• Phase: Phase 4
• First received: April 20, 2007
• Last updated: January 3, 2010
• Start date: October 1998
• Est. completion date: December 2008

Study information

• Verified date: January 2010
• Source: PETHEMA Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myeloblastic Leukaemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• ARA-C

• Idarubicin

• Leucomax

Locations

Country	Name	City	State
Spain	Hospital General de Albacete	Albacete
Spain	Hospital Universitario	Alicante
Spain	Hospital Puerta del Mar	Cádiz
Spain	Hospital Ntra. Sra. del Rossell	Cartagena
Spain	Hospital General	Castellón
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 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

Sponsors (1)

Lead Sponsor	Collaborator
PETHEMA Foundation

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improve the complete response index in patients diagnosed of acute myeloblastic leukaemia over 65 years
Secondary	Evaluate the toxicity
Secondary	Evaluate the effect of haematopoietic growth factors

External Links

•   Pethema Foundation web
•   Spanish association of Haematology