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

NCT00526175 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2016-01-20

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • PETHEMA Foundation

    lead OTHER

Principal Investigators

  • Ribera Josep Mª, Dr · Germans Trias i Pujol Hospital

  • Bastida Pilar, Dr · Hospital Materno-Infantil Vall d'Hebron

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-06-30
Primary Completion
2015-05-31
Completion
2015-12-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00526175 on ClinicalTrials.gov