Treatment of the Acute Myeloblastic Leukaemia in Patients Over 65 Years
Primary Purpose
Acute Myeloblastic Leukaemia
Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
ARA-C
Idarubicin
Leucomax
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myeloblastic Leukaemia focused on measuring Acute Myeloblastic Leukaemia
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
Sites / Locations
- Hospital General de Albacete
- Hospital Universitario
- Hospital Ntra. Sra. del Rossell
- Hospital General
- Hospital Puerta del Mar
- Hospital de Galdacano
- Hospital Ciudad de Jaén
- Hospital Insular de las Palmas
- Hospital Xeral
- Hospital Clínico San Carlos
- Hospital Ramón y Cajal
- Hospital Universitario de Alcalá de Henares
- Hospital Morales Messeguer
- Hospital Virgen de la Arrixaca
- Hospital Virgen de la Victoria
- Hospital Central de Asturias
- Clínica Universitaria de Pamplona
- Hospital Montecelo
- Hospital Clínico Universitario
- Hospital Arnau de Vilanova
- Hospital Clínico
- Hospital Dr. Pesset
- Hospital Clínico
- Hospital Virgen de la Concha
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00464217
Brief Title
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
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
October 1998 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
PETHEMA Foundation
4. Oversight
Data Monitoring Committee
Yes
5. 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
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloblastic Leukaemia
Keywords
Acute Myeloblastic Leukaemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ARA-C
Intervention Type
Drug
Intervention Name(s)
Idarubicin
Intervention Type
Drug
Intervention Name(s)
Leucomax
Primary Outcome Measure Information:
Title
Improve the complete response index in patients diagnosed of acute myeloblastic leukaemia over 65 years
Secondary Outcome Measure Information:
Title
Evaluate the toxicity
Title
Evaluate the effect of haematopoietic growth factors
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Garcia Laraña Jose, Dr
Organizational Affiliation
Hospital Universitario Ramon y Cajal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital General de Albacete
City
Albacete
Country
Spain
Facility Name
Hospital Universitario
City
Alicante
Country
Spain
Facility Name
Hospital Ntra. Sra. del Rossell
City
Cartagena
Country
Spain
Facility Name
Hospital General
City
Castellón
Country
Spain
Facility Name
Hospital Puerta del Mar
City
Cádiz
Country
Spain
Facility Name
Hospital de Galdacano
City
Galdacano
Country
Spain
Facility Name
Hospital Ciudad de Jaén
City
Jaen
Country
Spain
Facility Name
Hospital Insular de las Palmas
City
Las Palmas de Gran Canaria
Country
Spain
Facility Name
Hospital Xeral
City
Lugo
Country
Spain
Facility Name
Hospital Clínico San Carlos
City
Madrid
Country
Spain
Facility Name
Hospital Ramón y Cajal
City
Madrid
Country
Spain
Facility Name
Hospital Universitario de Alcalá de Henares
City
Madrid
Country
Spain
Facility Name
Hospital Morales Messeguer
City
Murcia
Country
Spain
Facility Name
Hospital Virgen de la Arrixaca
City
Murcia
Country
Spain
Facility Name
Hospital Virgen de la Victoria
City
Málaga
Country
Spain
Facility Name
Hospital Central de Asturias
City
Oviedo
Country
Spain
Facility Name
Clínica Universitaria de Pamplona
City
Pamplona
Country
Spain
Facility Name
Hospital Montecelo
City
Pontevedra
Country
Spain
Facility Name
Hospital Clínico Universitario
City
Salamanca
Country
Spain
Facility Name
Hospital Arnau de Vilanova
City
Valencia
Country
Spain
Facility Name
Hospital Clínico
City
Valencia
Country
Spain
Facility Name
Hospital Dr. Pesset
City
Valencia
Country
Spain
Facility Name
Hospital Clínico
City
Valladolid
Country
Spain
Facility Name
Hospital Virgen de la Concha
City
Zamora
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
24117042
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.
Results Reference
derived
Links:
URL
http://www.aehh.org
Description
Spanish association of Haematology
Learn more about this trial
Treatment of the Acute Myeloblastic Leukaemia in Patients Over 65 Years
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