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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00526175
Recruitment Status : Completed
First Posted : September 10, 2007
Last Update Posted : January 20, 2016
Information provided by (Responsible Party):
PETHEMA Foundation

Brief Summary:
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 or disease Intervention/treatment 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

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: LAL-BR/2001: Study Treatment to Low Risk ALL
Study Start Date : June 2001
Primary Completion Date : May 2015
Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. To evaluate the efficacy of treatment in order to response rate, relapse free survival and global survival [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00526175

Complejo Hospitalario Universitario de Albacete
Albacete, Spain
Hospital General de Alicante
Alicante, Spain
Hospital de Badalona Germans Trias i Pujol
Badalona, Spain
Hospital de Sant Pau
Barcelona, Spain
Hospital del Mar
Barcelona, Spain
Hospital Valle Hebrón-Materno Infantil
Barcelona, Spain
Basurtuko Ospitalea
Basurto, Spain
Complejo Hospitalario Reina Sofía
Córdoba, Spain
Hospital General de Guadalajara
Guadalajara, Spain
Complejo Hospitalario León
Leon, Spain
Hospital Clínico San Carlos de Madrid
Madrid, Spain
. Hospital Clínico Universitario Virgen de la Victoria
Málaga, Spain
Complejo Asistencial Son Dureta
Palma de Mallorca, Spain
Hospital Clinico Universitario
Salamanca, Spain
Hospital Clínico Universitario de Salamanca
Salamanca, Spain
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, Spain
Hospital General de Segovia
Segovia, Spain
H.U. Virgen del Rocio
Sevilla, Spain
Hospital Joan XXIII
Tarragona, Spain
Hospital Arnau de Vilanova
Valencia, Spain
Hospital Clínic
Valencia, Spain
Hospital La Fe
Valencia, Spain
Hospital Universitario Dr. Peset
Valencia, Spain
Hospital Clínico de Valladolid
Valladolid, Spain
Hospital Clínico Lozano Blesa
Zaragoza, Spain
Sponsors and Collaborators
PETHEMA Foundation
Study Chair: Ribera Josep Mª, Dr Germans Trias i Pujol Hospital
Study Chair: Bastida Pilar, Dr Hospital Materno-Infantil Vall d'Hebron

Additional Information:
Responsible Party: PETHEMA Foundation
ClinicalTrials.gov Identifier: NCT00526175     History of Changes
Other Study ID Numbers: LAL-BR/2001
First Posted: September 10, 2007    Key Record Dates
Last Update Posted: January 20, 2016
Last Verified: January 2016

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

Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Antimetabolites, Antineoplastic