Treatment of the Acute Myeloblastic Leukaemia in Patients Over 65 Years

NCT00464217 | Completed Phase 4 DMC

• 1 other identifier: PETHEMA/LAM-99
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 24

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

Conditions

Acute Myeloblastic Leukaemia

Keywords

Acute Myeloblastic Leukaemia

Outcome Measures

Primary Outcomes (1)

• Improve the complete response index in patients diagnosed of acute myeloblastic leukaemia over 65 years

Secondary Outcomes (2)

• Evaluate the toxicity

• Evaluate the effect of haematopoietic growth factors

Interventions

ARA-C DRUG

Idarubicin DRUG

Leucomax DRUG

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Cytologic diagnosis of acute myeloblastic leukaemia (excluded M3)
• Over 65 years

You may not qualify if:

• 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

Sponsors & Collaborators

• PETHEMA Foundation: lead

Study Sites (24)

Hospital General de Albacete

Albacete, Spain

Location

Hospital Universitario

Alicante, Spain

Location

Hospital Puerta del Mar

Cadiz, Spain

Location

Hospital Ntra. Sra. del Rossell

Cartagena, Spain

Location

Hospital General

Castellon, Spain

Location

Hospital de Galdacano

Galdakao, Spain

Location

Hospital Ciudad de Jaén

Jaén, Spain

Location

Hospital Insular de las Palmas

Las Palmas de Gran Canaria, Spain

Location

Hospital Xeral

Lugo, Spain

Location

Hospital Clínico San Carlos

Madrid, Spain

Location

Hospital Ramón y Cajal

Madrid, Spain

Location

Hospital Universitario de Alcalá de Henares

Madrid, Spain

Location

Hospital Virgen de la Victoria

Málaga, Spain

Location

Hospital Morales Messeguer

Murcia, Spain

Location

Hospital Virgen de la Arrixaca

Murcia, Spain

Location

Hospital Central de Asturias

Oviedo, Spain

Location

Clínica Universitaria de Pamplona

Pamplona, Spain

Location

Hospital Montecelo

Pontevedra, Spain

Location

Hospital Clínico Universitario

Salamanca, Spain

Location

Hospital Arnau de Vilanova

Valencia, Spain

Location

Hospital Clínico

Valencia, Spain

Location

Hospital Dr. Pesset

Valencia, Spain

Location

Hospital Clínico

Valladolid, Spain

Location

Hospital Virgen de la Concha

Zamora, Spain

Location

Related Publications (1)

• 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.

  PMID: 24117042 DERIVED

Related Links

• Spanish association of Haematology

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Cytarabine; Idarubicin; molgramostim

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Garcia Laraña Jose, Dr

  Hospital Universitario Ramon y Cajal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 20, 2007
• First Posted: April 23, 2007
• Study Start: October 1, 1998
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: January 5, 2010

Record last verified: 2010-01

Locations

ES (24)