Prednisone and Vincristine and Daunorubicin in Acute Lymphoblastic Leukemia - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Acute Lymphoblastic Leukemia

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 Clinico 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 Rocío
  - 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 Clinic
  - 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

Spanish association of Haematology

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