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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
PETHEMA Foundation Identifier:
First received: September 6, 2007
Last updated: September 16, 2015
Last verified: September 2015
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:

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 2015
Primary Completion Date: May 2015 (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


Ages Eligible for Study:   up to 15 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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 Universitario Dr. Peset
Valencia, Spain
Hospital Clínic
Valencia, Spain
Hospital La Fe
Valencia, Spain
Hospital Arnau de Vilanova
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
  More Information

Additional Information:
No publications provided

Responsible Party: PETHEMA Foundation Identifier: NCT00526175     History of Changes
Other Study ID Numbers: LAL-BR/2001
Study First Received: September 6, 2007
Last Updated: September 16, 2015
Health Authority: Spain: Ministry of Health

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

Additional relevant MeSH terms:
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Anti-Infective Agents
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on November 27, 2015