Treatment of the Acute Myeloblastic Leukaemia in Patients Over 65 Years

Sponsor

PETHEMA Foundation (Other)

Overall Status

Completed

CT.gov ID

NCT00464217

Collaborator

(none)

100

Enrollment

Locations

122

Duration (Months)

4.2

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloblastic Leukaemia	Drug: ARA-C Drug: Idarubicin Drug: Leucomax	Phase 4

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)

Study Design

Study Type:

Interventional

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

Study Start Date :

Oct 1, 1998

Actual Primary Completion Date :

Dec 1, 2008

Actual Study Completion Date :

Dec 1, 2008

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country
1	Hospital General de Albacete	Albacete	Spain
2	Hospital Universitario	Alicante	Spain
3	Hospital Ntra. Sra. del Rossell	Cartagena	Spain
4	Hospital General	Castellón	Spain
5	Hospital Puerta del Mar	Cádiz	Spain
6	Hospital de Galdacano	Galdacano	Spain
7	Hospital Ciudad de Jaén	Jaen	Spain
8	Hospital Insular de las Palmas	Las Palmas de Gran Canaria	Spain
9	Hospital Xeral	Lugo	Spain
10	Hospital Clínico San Carlos	Madrid	Spain
11	Hospital Ramón y Cajal	Madrid	Spain
12	Hospital Universitario de Alcalá de Henares	Madrid	Spain
13	Hospital Morales Messeguer	Murcia	Spain
14	Hospital Virgen de la Arrixaca	Murcia	Spain
15	Hospital Virgen de la Victoria	Málaga	Spain
16	Hospital Central de Asturias	Oviedo	Spain
17	Clínica Universitaria de Pamplona	Pamplona	Spain
18	Hospital Montecelo	Pontevedra	Spain
19	Hospital Clínico Universitario	Salamanca	Spain
20	Hospital Arnau de Vilanova	Valencia	Spain
21	Hospital Clínico	Valencia	Spain
22	Hospital Dr. Pesset	Valencia	Spain
23	Hospital Clínico	Valladolid	Spain
24	Hospital Virgen de la Concha	Zamora	Spain