LAL-Ph-2000: Treatment of Acute Lymphoblastic Leukemia Chromosome Philadelphia Positive
- Conditions
- Acute Lymphoblastic Leukemia
- Registration Number
- NCT00526305
- Lead Sponsor
- PETHEMA Foundation
- Brief Summary
Due to ALL Ph+ patients should receive a different treatment, is proposed a therapeutical protocol with: intensification treatment of induction to increment the CR rate, allogenic transplantation in first CR, autologous transplantation follow by alfa interferon in patients cannot done allogenic transplantation.
- Detailed Description
Remission Induction:
* Vincristine (VCR): 1,5 mg/m2 i.v., days 1 and 8
* Daunorubicin (DNR): 60 mg/m2 i.v., days 1 and 8.
* Prednisone (PDN): 60 mg/m2/day, i.v. or p.o., days 1 to 14
* L-asparaginase (L-ASA): 10.000 UI/m2, i.v.days 5-7 and 11-13
Results:
1. Standard response: The induction treatment will be completed with the same drugs, changing L-ASA to ARA-C, during two more weeks
2 Slow response. Chemotherapy with mitoxantrone and high dose ARA-C
Intrathecal chemotherapy:
Treatment with mitoxantrone, ARA-C e hydrocortisone, days 1 and 22
CONSOLIDATION TREATMENT 1
Start in two weeks after last dose of induction chemotherapy:
* Mercaptopurine (MP) 50 mg/m2, p.o., days 1-7, 28-35 and 56-63
* Mitoxantrone (MTX): 3g/m2, i.v., in 24 hours, day 1, 28 and 56.
* VM-26: 150 mg/m2 every 12 horas, i.v. (infusión 1 hora), días 14 y 42
* ARA-C: 500 mg/m2 cada 12 hours, i.v., in 3 hours, days 14-15 and 42-43
* Intrathecal treatment, days 28 and 56.
6.4. CONSOLIDATION TREATMENT 2
Start in a week after last dose of mercaptopurine of previous cycle
* Dexamethasone (DXM):
* 10 mg/m2 day, p.o. or i.v. days 1-14
* 5 mg/m2 day, p.o. or i.v., days 15-21
* Vincristine (VCR): 1,5 mg/m2 i.v., days 1 and 8 and 15
* Daunorubicin (DNR): 30 mg/m2 i.v., days 1, 2, 8 and 9.
* CFM 600 mg/m2 day, i.v., days 1 and 15
* L-asparaginase (L-ASA): 10.000 UI/m2, i.v.or im , days 1-3 and 15-17
* Intrathecal treatment days 1 and 15.
TRANSPLANTATION
Hematopoietic autologous transplantation with related donor, one or two months after last dose of consolidation treatment.
Hematopoietic autologous transplantation with unrelated donor, in patients younger than 45, and with PS 0-1
Hematopoietic autologous transplantation in patients without related donor and without unrelated donor after six months searching
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
ALL BCR/ABL+ patients Age < 65 years No previous treatment
- Other LLA variability
- Previous history of coronary valvular, hypertensive cardiopathy illness
- Chronic hepatic illness
- Chronic respiratory insufficiency
- Renal insufficiency not caused by LLA
- Severe neurological problems not caused by LLA
- Severe affection of the performance status (grade 3-4 OMS gradation) not caused by LLA
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method To evaluate the efficacy of treatment in order to response rate, relapse free survival and overall survival 5 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (49)
Hospital General de Segovia
🇪🇸Segovia, Spain
Hospital Universitario de Canarias
🇪🇸Tenerife, Spain
H.U. Virgen del Rocio
🇪🇸Sevilla, Spain
Hospital Clínico Universitario de Valencia
🇪🇸Valencia, Spain
Hospital dr. Peset
🇪🇸Valencia, Spain
Hospital La Fe
🇪🇸Valencia, Spain
Complejo Hospitalario de Pontevedra_Hospital Montecelo
🇪🇸Pontevedra, Spain
Complejo Hospitalario Universitario de Vigo
🇪🇸Vigo, Spain
Hospital de Galdakao
🇪🇸Vizcaya, Spain
Complexo Hospitalario Xeral-Calde
🇪🇸Lugo, Spain
Hospital Clínico de Valladolid
🇪🇸Valladolid, Spain
Hospital Clínico Lozano Blesa
🇪🇸Zaragoza, Spain
Hospital Central de Asturias
🇪🇸Oviedo, Asturias, Spain
Hospital de Navarra
🇪🇸Pamplona, Navarra, Spain
Hospital Verge de la Cinta
🇪🇸Tortosa, Tarragona, Spain
Complejo Hospitalario Universitario de Albacete
🇪🇸Albacete, Spain
Hospital Clínic
🇪🇸Valencia, Spain
Hospital General de Alicante
🇪🇸Alicante, Spain
Hospital Ntra. Sra. Sonsoles
🇪🇸Avila, Spain
Hospital de Badalona Germans Trias i Pujol
🇪🇸Badalona, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
Complejo Hospitalario León
🇪🇸Leon, Spain
Hospital de Jerez de la Frontera
🇪🇸Jerez de La Frontera, Spain
Hospital 12 de Octubre
🇪🇸Madrid, Spain
Basurtuko Ospitalea
🇪🇸Basurto, Spain
Hospital Arnau de Vilanova
🇪🇸Lleida, Spain
Clínica Puerta de Hierro
🇪🇸Madrid, Spain
Hospital Clínico San Carlos de Madrid
🇪🇸Madrid, Spain
Hospital de la Princesa
🇪🇸Madrid, Spain
Hospital Universitario de la Princesa
🇪🇸Madrid, Spain
Althaia, Xarxa Asistencial de Manresa
🇪🇸Manresa, Spain
Hospital General Universitario Gregorio Marañón, Madrid
🇪🇸Madrid, Spain
Hospital General Morales Meseguer
🇪🇸Murcia, Spain
Complejo Asistencial Son Dureta
🇪🇸Palma de Mallorca, Spain
Hospital Santa María del Rosell
🇪🇸Murcia, Spain
Hospital General Universitario Morales Meseguer.
🇪🇸Murcia, Spain
Hospital Son Llatzer
🇪🇸Palma de Mallorca, Spain
Corporació Sanitaria Parc Taulí
🇪🇸Sabadell, Spain
Hospital Clínico Universitario de Salamanca
🇪🇸Salamanca, Spain
Hospital de Cruces
🇪🇸Bilbao, Spain
Complejo Hospitalario Universitario de Santiago
🇪🇸Santiago de Compostela, Spain
H. Carlos Haya
🇪🇸Málaga, Spain
Hospital vall d'Hebrón
🇪🇸Barcelona, Spain
Hospital de Sagunto
🇪🇸Sagunto, Spain
Hospital de Sant Pau
🇪🇸Barcelona, Spain
. Hospital Clínico Universitario Virgen de la Victoria
🇪🇸Málaga, Spain
Hospital General Universitario
🇪🇸Valencia, Spain
Clínica Universitaria de Navarra
🇪🇸Pamplona, Spain
Hospital general de Castellón
🇪🇸Castello, Castellón, Spain