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LAL-BR/2001: Study Treatment to Low Risk ALL

This study is currently recruiting participants.
Verified February 2013 by PETHEMA Foundation
Sponsor:
Information provided by (Responsible Party):
PETHEMA Foundation
ClinicalTrials.gov Identifier:
NCT00526175
First received: September 6, 2007
Last updated: February 27, 2013
Last verified: February 2013
History of Changes
  Purpose

The purpose of this study is increase the efficacy of consolidation (C1) after an intensification phase with high dose of methotrexate, applying analysis of minimal residual disease


Condition Intervention Phase
Acute Lymphoblastic Leukemia
 Drug: Prednisone
Drug: Vincristine
Drug: Daunorubicin
Drug: L-Asparaginase
Drug: Cyclophosphamide
Drug: Methotrexate
Drug: Cytosine Arabinoside
Drug: Mercaptopurine
Drug: VP-16
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: LAL-BR/2001: Study Treatment to Low Risk ALL

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by PETHEMA Foundation:

Primary Outcome Measures:
  • To evaluate the efficacy of treatment in order to response rate, relapse free survival and global survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: June 2001
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Prednisone
    60 mg/m2 day, i.v. or oral, dyas 1 to 27 30 mg/m2 day, i.v. or oral, days 28 to 35
    Drug: Vincristine
    1,5 mg/m2 i.v., days 8, 15, 22 and 28
    Drug: Daunorubicin
    30 mg/m2, i.v., days 8 and 15
    Drug: L-Asparaginase
    10.000 UI/m2, i.m. or i.v., days 9 to 11, 16 to 18 and 23 to 25. Total: 9 doses.
    Drug: Cyclophosphamide
    1000 mg/m2, i.v., day 22.
    Drug: Methotrexate
    Age <1 year 1-2 years 2-3 years > 3 years MTX 5 mg 8 mg 10 mg 12 mg
    Drug: Cytosine Arabinoside
    Edad <1 year 1-2 years 2-3 years > 3 years ARA-C 16 mg 16 mg 20 mg 30 mg
    Drug: Mercaptopurine
    50 mg/m2,oral, days 1 to 7, 28-35 and 56-63
    Drug: VP-16
    150 mg/m2 i.v., days 14-15 and 42-43
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnoses of low risk acute lymphoblastic leukemia in children no treated previously

Exclusion Criteria:

  • Mature B-ALL (FABL3) or with cytogenetic ALL "Burkitt-like" alterations (t[8;14], t[2;8], t[8;22])
  • Mixed forms of ALL
  • Acute Leukemia no differentiate
  • Patients with coronary disorders, valvular or hypertensive cardiopathy
  • Patients with chronic liver disorders
  • Chronic pulmonary disorders
  • Renal insufficiency
  • Neurologic disfunctions
  • ECOG 3 and 4
  • No signed consent form
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00526175

Contacts
Contact: Bastida Pilar, Dr. 34-93- 4893093

Locations
Spain
Complejo Hospitalario Universitario de Albacete Recruiting
Albacete, Spain
Principal Investigator: Santiago José, Dr            
Hospital General de Alicante Recruiting
Alicante, Spain
Contact: Rivas Concepción            
Principal Investigator: Rivas Concepción, Dr            
Hospital de Badalona Germans Trias i Pujol Recruiting
Badalona, Spain
Principal Investigator: Oriol Albert, DR            
Hospital de Sant Pau Recruiting
Barcelona, Spain
Principal Investigator: Brunet Salut, Dr            
Hospital del Mar Recruiting
Barcelona, Spain
Principal Investigator: Abella Eugenia, Dr            
Hospital Valle Hebrón-Materno Infantil Recruiting
Barcelona, Spain
Principal Investigator: Bastida Pilar, Dr            
Basurtuko Ospitalea Recruiting
Basurto, Spain
Contact: Beltran de Heredia José Mª, Dr            
Principal Investigator: Beltran de Heredia Jose Mª, Dr            
Complejo Hospitalario Reina Sofía Recruiting
Córdoba, Spain
Contact: Torres Antonio, Dr            
Principal Investigator: Torres Antonio, DR            
Hospital General de Guadalajara Recruiting
Guadalajara, Spain
Principal Investigator: Diaz Miguel, Dr            
Complejo Hospitalario León Recruiting
Leon, Spain
Principal Investigator: Ramos Fernando, Dr            
Hospital Clínico San Carlos de Madrid Recruiting
Madrid, Spain
Contact: Diaz Mediavilla Joaquin, Dr            
Principal Investigator: Díaz Mediavilla Joaquín, Dr            
. Hospital Clínico Universitario Virgen de la Victoria Recruiting
Málaga, Spain
Contact: del Castillo Santiago, Dr            
Principal Investigator: del Castillo Santiago, Dr            
. Hospital Clínico Universitario Virgen de la Victoria Recruiting
Málaga, Spain
Contact: Gema Ramirez            
Principal Investigator: Ramirez Gema, Dr            
Complejo Asistencial Son Dureta Recruiting
Palma de Mallorca, Spain
Principal Investigator: Sampol Antonia            
Hospital Clinico Universitario Recruiting
Salamanca, Spain
Contact: Del Cañizo Consuelo, Dr            
Hospital Clínico Universitario de Salamanca Recruiting
Salamanca, Spain
Contact: Vazquez Lourdes, Dr            
Principal Investigator: Vazquez Lourdes, Dr            
Complejo Hospitalario Universitario de Santiago Recruiting
Santiago de Compostela, Spain
Principal Investigator: Bello Jose Luis, Dr            
Hospital General de Segovia Recruiting
Segovia, Spain
Principal Investigator: Hernández José Mariano            
H.U. Virgen del Rocio Recruiting
Sevilla, Spain
Principal Investigator: Parody Ricardo, Dr            
Hospital Joan XXIII Recruiting
Tarragona, Spain
Contact: Escoda Lourdes, Dr            
Principal Investigator: Escoda Lourdes            
Hospital Arnau de Vilanova Recruiting
Valencia, Spain
Principal Investigator: Lopez Aurelio, Dr            
Hospital Universitario Dr. Peset Recruiting
Valencia, Spain
Contact: Ribas Paz, Dr            
Principal Investigator: Ribas Paz, Dr            
Hospital Clínic Recruiting
Valencia, Spain
Contact: Terol Maria José, Dr            
Principal Investigator: Terol Mª José, Dr            
Hospital La Fe Recruiting
Valencia, Spain
Contact: de la Rubia Javier, Dr            
Principal Investigator: de la Rubia Javier, Dr            
Hospital Clínico de Valladolid Recruiting
Valladolid, Spain
Principal Investigator: Fernandez Calvo Francisco, Dr            
Hospital Clínico Lozano Blesa Recruiting
Zaragoza, Spain
Contact: Palomera Luis, Dr            
Principal Investigator: Palomera Luis, Dr            
Sponsors and Collaborators
PETHEMA Foundation
Investigators
Study Chair: Ribera Josep Mª, Dr HOSPITAL GERMANS TRIAS I PUJOL
Study Chair: Bastida Pilar, Dr Hospital Materno-Infantil Vall d'Hebron
  More Information

Additional Information:
Spanish association of Haematology  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: PETHEMA Foundation
ClinicalTrials.gov Identifier: NCT00526175     History of Changes
Other Study ID Numbers: LAL-BR/2001
Study First Received: September 6, 2007
Last Updated: February 27, 2013
Health Authority: Spain: Ministry of Health

Keywords provided by PETHEMA Foundation:
Acute Lymphoblastic Leukemia
Minimal Residual Disease

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
6-Mercaptopurine
Cytarabine
Methotrexate
Cyclophosphamide
Asparaginase
Daunorubicin
 Prednisone
Vincristine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Antirheumatic Agents
Antineoplastic Agents, Alkylating

ClinicalTrials.gov processed this record on May 16, 2013