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

PHASE4CompletedINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

June 30, 2001

Primary Completion Date

May 31, 2015

Study Completion Date

December 31, 2015

Conditions
Acute Lymphoblastic Leukemia
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

Trial Locations (25)

Unknown

Hospital General de Alicante, Alicante

Hospital Valle Hebrón-Materno Infantil, Barcelona

Complejo Hospitalario Reina Sofía, Córdoba

Hospital Clínico San Carlos de Madrid, Madrid

. Hospital Clínico Universitario Virgen de la Victoria, Málaga

Hospital Joan XXIII, Tarragona

Hospital Clínic, Valencia

Hospital La Fe, Valencia

Hospital Universitario Dr. Peset, Valencia

Hospital Clínico Lozano Blesa, Zaragoza

Complejo Hospitalario Universitario de Albacete, Albacete

Hospital de Badalona Germans Trias i Pujol, Badalona

Hospital de Sant Pau, Barcelona

Hospital del Mar, Barcelona

Basurtuko Ospitalea, Basurto

Hospital General de Guadalajara, Guadalajara

Complejo Hospitalario León, León

Complejo Asistencial Son Dureta, Palma de Mallorca

Hospital Clinico Universitario, Salamanca

Hospital Clínico Universitario de Salamanca, Salamanca

Complejo Hospitalario Universitario de Santiago, Santiago de Compostela

Hospital General de Segovia, Segovia

H.U. Virgen del Rocio, Seville

Hospital Arnau de Vilanova, Valencia

Hospital Clínico de Valladolid, Valladolid

All Listed Sponsors
lead

PETHEMA Foundation

OTHER

NCT00526175 - LAL-BR/2001: Study Treatment to Low Risk ALL | Biotech Hunter | Biotech Hunter