Idarubicin and Molgramostim and ARA-C in Acute Myeloblastic Leukaemia - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Acute Myeloblastic Leukaemia

Intervention / Treatment

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 Type

Interventional

Enrollment

100

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Spain
- - Albacete, Spain
    - Hospital General de Albacete
  - Alicante, Spain
    - Hospital Universitario
  - Cartagena, Spain
    - Hospital Ntra. Sra. del Rossell
  - Castellón, Spain
    - Hospital General
  - Cádiz, Spain
    - Hospital Puerta del Mar
  - Galdacano, Spain
    - Hospital de Galdácano
  - Jaen, Spain
    - Hospital Ciudad de Jaén
  - Las Palmas de Gran Canaria, Spain
    - Hospital Insular de las Palmas
  - Lugo, Spain
    - Hospital Xeral
  - Madrid, Spain
    - Hospital Ramon y Cajal
  - Madrid, Spain
    - Hospital Clinico San Carlos
  - Madrid, Spain
    - Hospital Universitario de Alcalá de Henares
  - Murcia, Spain
    - Hospital Virgen de la Arrixaca
  - Murcia, Spain
    - Hospital Morales Messeguer
  - Málaga, Spain
    - Hospital Virgen de la Victoria
  - Oviedo, Spain
    - Hospital Central de Asturias
  - Pamplona, Spain
    - Clínica Universitaria de Pamplona
  - Pontevedra, Spain
    - Hospital Montecelo
  - Salamanca, Spain
    - Hospital Clinico Universitario
  - Valencia, Spain
    - Hospital Arnau de Vilanova
  - Valencia, Spain
    - Hospital Clínico
  - Valencia, Spain
    - Hospital Dr. Pesset
  - Valladolid, Spain
    - Hospital Clínico
  - Zamora, Spain
    - Hospital Virgen de la Concha

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Evaluate the toxicity
Evaluate the effect of haematopoietic growth factors

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PETHEMA Foundation

Investigators

Principal Investigator: Garcia Laraña Jose, Dr, Hospital Universitario Ramon Y Cajal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Helpful Links

Spanish association of Haematology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 1998

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

April 20, 2007

First Submitted That Met QC Criteria