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

January 16, 2016 updated by: PETHEMA Foundation
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

REMISION INDUCTION

Systemic chemotherapy:

Prednisolone (PDN):

  • 60 mg/m2 day, i.v. or p.o., days 1 to 27
  • 30 mg/m2 day, i.v. or p.o., days 28 to 35

Vincristine (VCR): 1,5 mg/m2 i.v., days 8, 15, 22 and 28. Daunorubicin (DNR): 30 mg/m2, i.v., days 8 and 15. L-asparaginase (L-ASA): 10.000 UI/m2, i.m. or i.v., days 9 to 11, 16 to 18 and 23 to 25.

Cyclophosphamide (CFM): 1000 mg/m2, i.v., day 22.

Intracranial chemotherapy

Methotrexate (MTX), cytosine (ARA-C) and hydrocortisone, days 1 and 22

CONSOLIDATION TREATMENT (WEEKS 6 TO 14)with INTENSIFICACIÓN (C-1)

  • Mercaptopurine (MP) 50 mg/m2, p.o., days 1-7, 28-35 and 56-63
  • MTX: 3g/m2, i.v., in 24 hours, days 1, 28 and 56.
  • VP-16: 150 mg/m2 i.v., days 14-15 and 42-43
  • ARA-C: 1000 mg/m2 i.v., in 3 hours, days 14-15 and 42-43
  • Intrathecal treatment, days 1, 28 and 56.

REINDUCTION-CONSOLIDATION TREATMENT (R-C) (WEEKS 15 TO 23)

Dexamethasone (DXM):

  • 6 mg/m2 day, p.o., days 1-21
  • 3 mg/m2 day, p.o. or i.v., days 22-28 VCR: 1,5 mg/m2, i.v., days 1, 8 and 15 DNR: 30 mg/m2, i.v., days 1 and 8 L-ASA: 10.000 UI/m2 i.m. or i.v., days 8 and 9, 15 and 16, 22 and 23. CFM 1000 mg/m2 day, i.v., day 22 Mercaptopurine (MP) 50 mg/m2, p.o., days 35-42 MTX: 3g/m2, i.v., in 24 hours, day 35. VP-16: 150 mg/m2 i.v., days 49-50 ARA-C: 1.000 mg/m2 i.v., in 3 hours, days 49-50 Intrathecal treatment days 1 and 35.

MAINTENANCE TREATMENT (M-1)

Continuous treatment

  • MP 50 mg/m2/day, p.o.
  • MTX 20 mg/m2/week, i.m.

Reinductions

  • VCR: 1,5 mg/m2 i.v., day 1.
  • PDN: 30 mg/m2/day, i.v. or p.o., days 1 to 7
  • L-ASA: 20.000 UI/m2, i.m. or i.v., day 1.
  • Intrathecal treatment day 1 Five cycles, weeks 24, 30, 36, 42 and 48. During the week of administration cycle, continuous chemotherapy should be suspended.

Intrathecal treatment: At the start of any reinduction cycle

MAINTENANCE TREATMENT (M-2) (WEEKS 55-108)

  • MP 50 mg/m2/day, p.o.
  • MTX 20 mg/m2/week, i.m.
  • Intrathecal treatment, weeks 54 and 108

At the end of treatment should be done the study of MRD (flux cytometry)

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate the efficacy of treatment in order to response rate, relapse free survival and global survival
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PETHEMA Foundation

Investigators

  • Study Chair: Ribera Josep Mª, Dr, Germans Trias I Pujol Hospital
  • Study Chair: Bastida Pilar, Dr, Hospital Materno-Infantil Vall d'Hebron

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2001

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

September 6, 2007

First Submitted That Met QC Criteria

September 6, 2007

First Posted (Estimate)

September 10, 2007

Study Record Updates

Last Update Posted (Estimate)

January 20, 2016

Last Update Submitted That Met QC Criteria

January 16, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LAL-BR/2001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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