LAL-Ph-2000: Treatment of Acute Lymphoblastic Leukemia Chromosome Philadelphia Positive

PHASE4CompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

January 31, 2000

Primary Completion Date

April 30, 2005

Study Completion Date

April 30, 2005

Conditions
Acute Lymphoblastic Leukemia
Interventions
DRUG

Vincristine

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

DRUG

Daunorubicin

60 mg/m2, i.v., days 1 and 8

DRUG

Prednisone

60 mg/m2 day, i.v. or oral, days 1 to 14

DRUG

L-Asparaginase

10.000 UI/m2, i.v., days 5-7 and 11-13. Total: 6 doses.

DRUG

Mitoxantrone

12 mg/m2 i.v days 15, 16 and 17

DRUG

Cytosine Arabinoside

1.500 mg/m2 /12 hours, days 16, 17 and 18 (total: 6 doses) If slow response to treatment: 3.000 mg/m2/12 hours, days 18, 19, 20 and 21 (8 doses)

DRUG

Hydrocortisone

10 mg ,15 mg or 20 mg depending of age

DRUG

Mercaptopurine

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

DRUG

Cyclophosphamide

600 mg/m2 day, i.v., days 1 to 15 in consolidation

DRUG

Dexamethasone

10 mg/m2 day, oral or i.v. days 1-14 5 mg/m2 day, oral. or i.v., days 15-21

Trial Locations (50)

Unknown

Hospital General de Alicante, Alicante

Hospital Ntra. Sra. Sonsoles, Ávila

Hospital Clínic, Barcelona

Hospital del Mar, Barcelona

Hospital vall d'Hebrón, Barcelona

Hospital general de Castellón, Castelló

Hospital Arnau de Vilanova, Lleida

Hospital Clínico San Carlos de Madrid, Madrid

Hospital General Universitario Gregorio Marañón, Madrid, Madrid

Hospital Universitario de la Princesa, Madrid

Hospital General Universitario Morales Meseguer., Murcia

. Hospital Clínico Universitario Virgen de la Victoria, Málaga

Hospital de Navarra, Pamplona

Hospital Central de Asturias, Oviedo

Hospital Verge de la Cinta, Tortosa

Hospital Clínico Universitario de Valencia, Valencia

Hospital Clínic, Valencia

Hospital dr. Peset, Valencia

Hospital General Universitario, Valencia

Hospital La Fe, 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

Basurtuko Ospitalea, Basurto

Hospital de Cruces, Bilbao

Hospital de Jerez de la Frontera, Jerez de la Frontera

Complejo Hospitalario León, León

Complexo Hospitalario Xeral-Calde, Lugo

Clínica Puerta de Hierro, Madrid

Hospital 12 de Octubre, Madrid

Hospital de la Princesa, Madrid

Althaia, Xarxa Asistencial de Manresa, Manresa

H. Carlos Haya, Málaga

Hospital General Morales Meseguer, Murcia

Hospital Santa María del Rosell, Murcia

Complejo Asistencial Son Dureta, Palma de Mallorca

Hospital Son Llatzer, Palma de Mallorca

Clínica Universitaria de Navarra, Pamplona

Complejo Hospitalario de Pontevedra_Hospital Montecelo, Pontevedra

Corporació Sanitaria Parc Taulí, Sabadell

Hospital de Sagunto, Sagunto

Hospital Clínico Universitario de Salamanca, Salamanca

Hospital Universitario de Canarias, Santa Cruz de Tenerife

Complejo Hospitalario Universitario de Santiago, Santiago de Compostela

Hospital General de Segovia, Segovia

H.U. Virgen del Rocio, Seville

Hospital Clínico de Valladolid, Valladolid

Complejo Hospitalario Universitario de Vigo, Vigo

Hospital de Galdakao, Vizcaya

All Listed Sponsors
lead

PETHEMA Foundation

OTHER

NCT00526305 - LAL-Ph-2000: Treatment of Acute Lymphoblastic Leukemia Chromosome Philadelphia Positive | Biotech Hunter | Biotech Hunter