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

NCT00526175 | Completed Phase 4 DMC

• 1 other identifier: LAL-BR/2001
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 25

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

Conditions

Acute Lymphoblastic Leukemia

Keywords

Acute Lymphoblastic Leukemia; Minimal Residual Disease

Outcome Measures

Primary Outcomes (1)

• To evaluate the efficacy of treatment in order to response rate, relapse free survival and global survival

  2 years

Interventions

Prednisone DRUG

60 mg/m2 day, i.v. or oral, dyas 1 to 27 30 mg/m2 day, i.v. or oral, days 28 to 35

Vincristine DRUG

1,5 mg/m2 i.v., days 8, 15, 22 and 28

Daunorubicin DRUG

30 mg/m2, i.v., days 8 and 15

L-Asparaginase DRUG

10.000 UI/m2, i.m. or i.v., days 9 to 11, 16 to 18 and 23 to 25. Total: 9 doses.

Cyclophosphamide DRUG

1000 mg/m2, i.v., day 22.

Methotrexate DRUG

Age \<1 year 1-2 years 2-3 years \> 3 years MTX 5 mg 8 mg 10 mg 12 mg

Cytosine Arabinoside DRUG

Edad \<1 year 1-2 years 2-3 years \> 3 years ARA-C 16 mg 16 mg 20 mg 30 mg

Mercaptopurine DRUG

50 mg/m2,oral, days 1 to 7, 28-35 and 56-63

VP-16 DRUG

150 mg/m2 i.v., days 14-15 and 42-43

Eligibility Criteria

• Age: Up to 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• PETHEMA Foundation: lead

Study Sites (25)

Hospital General de Alicante

Alicante, Alicante, Spain

Location

Hospital Valle Hebrón-Materno Infantil

Barcelona, Barcelona, Spain

Location

Complejo Hospitalario Reina Sofía

Córdoba, Córdoba, Spain

Location

Hospital Clínico San Carlos de Madrid

Madrid, Madrid, Spain

Location

. Hospital Clínico Universitario Virgen de la Victoria

Málaga, Málaga, Spain

Location

Hospital Joan XXIII

Tarragona, Tarragona, Spain

Location

Hospital Clínic

Valencia, Valencia, Spain

Location

Hospital La Fe

Valencia, Valencia, Spain

Location

Hospital Universitario Dr. Peset

Valencia, Valencia, Spain

Location

Hospital Clínico Lozano Blesa

Zaragoza, Zaragoza, Spain

Location

Complejo Hospitalario Universitario de Albacete

Albacete, Spain

Location

Hospital de Badalona Germans Trias i Pujol

Badalona, Spain

Location

Hospital de Sant Pau

Barcelona, Spain

Location

Hospital del Mar

Barcelona, Spain

Location

Basurtuko Ospitalea

Basurto, Spain

Location

Hospital General de Guadalajara

Guadalajara, Spain

Location

Complejo Hospitalario León

León, Spain

Location

Complejo Asistencial Son Dureta

Palma de Mallorca, Spain

Location

Hospital Clinico Universitario

Salamanca, Spain

Location

Hospital Clínico Universitario de Salamanca

Salamanca, Spain

Location

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, Spain

Location

Hospital General de Segovia

Segovia, Spain

Location

H.U. Virgen del Rocio

Seville, Spain

Location

Hospital Arnau de Vilanova

Valencia, Spain

Location

Hospital Clínico de Valladolid

Valladolid, Spain

Location

Related Links

• Spanish association of Haematology

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Neoplasm, Residual

Interventions

Prednisone; Vincristine; Daunorubicin; Asparaginase; Cyclophosphamide; Methotrexate; Cytarabine; Mercaptopurine; Etoposide

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Aminoglycosides; Glycosides; Carbohydrates; Amidohydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Aminopterin; Pterins; Pteridines; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Sulfhydryl Compounds; Sulfur Compounds; Purines; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides

Study Officials

• Ribera Josep Mª, Dr

  Germans Trias i Pujol Hospital

  STUDY CHAIR

• Bastida Pilar, Dr

  Hospital Materno-Infantil Vall d'Hebron

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: September 6, 2007
• First Posted: September 10, 2007
• Study Start: June 1, 2001
• Primary Completion: May 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 20, 2016

Record last verified: 2016-01

Locations

ES (25)