PETHEMA LAL-RI/96: Treatment for Patients With Standard Risk Acute Lymphoblastic Leukemia
- Conditions
- Acute Lymphoblastic Leukemia
- Registration Number
- NCT00494897
- Lead Sponsor
- PETHEMA Foundation
- Brief Summary
The objective of current protocol is try improve the results of chemotherapy treatment in patients with ALL wich is not indicated the peripheral stem cell transplant in first remission, with an intensive consolidation follow by re-inductions.
- Detailed Description
Induction therapy:
Patients with standard risk receive vincristine (1,5 mg/m2)IV on days 1, 8, 15 and 22;daunorubicin (30 mg/m2)IV on days 1, 8, 15 and 22; oral or IV prednisone 60 mg/m2/day, days 1 to 27 and 30 mg/m2/day, days 28 to 35;asparaginase 10.000 UI/m2 IM or IV, days 10 to 12, 17 to 19 and 24 to 26;cyclophosphamide (500 mg/m2)IV days 1, 2 and 29; methotrexate, cytosine arabinoside and hydrocortisone, days 1 to 22.
Patients older than 55 years are not treated with asparaginase and cyclophosphamide.
Consolidation therapy (1):
Standard risk: Mercaptopurine 50 mg/m2, PO, days 1 to 7, 28-35 and 56-63; methotrexate (3g/m2)IV/24 hours, day 1, 28 and 56; VM-26 (150 mg/m2)/12 hours, IV, days 14 and 42; ARA-C (500 mg/m2)/12 hours, IV days 14-15 and 42-43; intrathecally treatment, days 1, 28 and 56.
Patients over 50 years: Mercaptopurine (50 mg/m2), PO, days 1 to 7, 28-35 and 56-63;methotrexate (1,5 g/m2) IV/24 hours, day 1, 28 and 56; VM-26 (150 mg/m2)/12 hours, IV days 14 and 42; ARA-C (500 mg/m2)/12 hours, IV days 14-15 and 42-43; intrathecally treatment, days 1, 28 and 56.
Consolidation therapy (2)/Reinduction: one cycle similar to induction. It starts one week after last dose of mercaptopurine.Dexamethasone 10 mg/m2/day,PO or IV, days 1-14 and 5 mg/m2/day, PO or IV days 15-21; VCR: 1,5 mg/m2 IV, days 1, 8 and 15; Daunorubicin 30 mg/m2 IV, days 1, 2, 8 and 9; cyclophosphamide 600 mg/m2/day IV, days 1 and 15; Asparaginase: 10.000 UI/m2 IM or IV, days 1-3 and 15-17;intrathecally treatment days 1 and 15
Maintenance therapy 1:administration of continuous chemotherapy (mercaptopurine and methotrexate) and reinductions until one year from diagnosis.
* Continuous chemotherapy:
* MP 50 mg/m2/day PO
* MTX 20 mg/m2/week IM
* Reinductions
* VCR: 1,5 mg/m2 IV, day 1.
* PDN: 60 mg/m2/day, IV or PO days 1 to 7
* L-ASA: 20.000 UI/m2, IM or IV day 1.
* Intrathecally day 1
Seven cycles, weeks 25, 29, 33, 37, 41, 45 and 49.
Maintenance therapy 2:administration of continuous chemotherapy (mercaptopurine and methotrexate) while second year from diagnosis (weeks 53 to 104).
* MP 50 mg/m2/day, PO
* MTX 20 mg/m2/week, IM.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 374
- Adults (over 15 years) with ALL standard risk no prior antiblastic chemotherapy
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Efficacy of treatment in adults with standard risk acute lymphoblastic leukemia 2 years
- Secondary Outcome Measures
Name Time Method Demonstrate that in this group of patients, the CNS relapse is not frequently and is not necessary cranial radiotherapy 2 years To evaluate the treatment tolerance 1 year
Trial Locations
- Locations (86)
Hospital Central de Asturias
🇪🇸Oviedo, Asturias, Spain
Hospital general de Castellón
🇪🇸Castello, Castellón, Spain
Hospital Mútua de Terrassa
🇪🇸Terrassa, Barcelona, Spain
Hospital de Sagunto
🇪🇸Sagunto, Spain
Hospital Ntra. Sra. Sonsoles
🇪🇸Avila, Spain
Hospital ClÃnic
🇪🇸Valencia, Spain
Basurtuko Ospitalea
🇪🇸Basurto, Spain
Hospital Valle Hebrón-Materno Infantil
🇪🇸Barcelona, Spain
Hospital Nuestra Señora de Alarcos
🇪🇸Ciudad Real, Spain
Hospital General de Elda
🇪🇸Elda, Spain
Hospital de Fuenlabrada
🇪🇸Madrid, Spain
Hospital Ramón y Cajal
🇪🇸Madrid, Spain
Hospital Puerta del Mar
🇪🇸Cádiz, Spain
Hospital General de Alicante
🇪🇸Alicante, Spain
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital General de Lanzarote
🇪🇸Lanzarote, Spain
Hospital de San Jorge
🇪🇸Huesca, Spain
Hospital Virgen de la Luz
🇪🇸Cuenca, Spain
Hospital Arnau de Vilanova
🇪🇸Lleida, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital Verge de la Cinta
🇪🇸Tortosa, Tarragona, Spain
Hospital vall d'Hebrón
🇪🇸Barcelona, Spain
Institut Català d'Oncologia,
🇪🇸Gerona, Spain
Hospital Regional Universitario Infanta Cristina
🇪🇸Badajoz, Spain
Hospital ClÃnico de Salamanca
🇪🇸Salamanca, Spain
Hospital Virgen del Camino
🇪🇸Pamplona, Spain
Complejo Hospitalario Universitario de Santiago
🇪🇸Santiago de Compostela, Spain
Hospital Nuestra Señora del Prado
🇪🇸Toledo, Spain
Hospital Txagorritxu
🇪🇸Vitoria, Spain
Hospital de la Princesa
🇪🇸Madrid, Spain
Complejo Hospitalario de Cáceres
🇪🇸Cáceres, Spain
Complejo Hospitalario Reina SofÃa
🇪🇸Córdoba, Spain
Hospital Universitario Virgen de las Nieves
🇪🇸Granada, Spain
Hospital Médico Quirúrgico Ciudad de Jaén
🇪🇸Jaen, Spain
Hospital Juan Canalejo
🇪🇸La Coruña, Spain
ClÃnica Puerta de Hierro
🇪🇸Madrid, Spain
Hospital 12 de Octubre
🇪🇸Madrid, Spain
Complejo Hospitalario León
🇪🇸Leon, Spain
Hospital de Jerez de la Frontera
🇪🇸Jerez de la Frontera, Spain
Hospital ClÃnico San Carlos de Madrid
🇪🇸Madrid, Spain
Hospital Doce de Octubre
🇪🇸Madrid, Spain
Hospital General Universitario Gregorio Marañón, Madrid
🇪🇸Madrid, Spain
Hospital Universitario Princcipe de Asturias
🇪🇸Madrid, Spain
Hospital Puerta de Hierro
🇪🇸Madrid, Spain
Hospital Universitario de la Princesa
🇪🇸Madrid, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Althaia, Xarxa Asistencial de Manresa
🇪🇸Manresa, Spain
Hospital General Morales Meseguer
🇪🇸Murcia, Spain
Hospital Santa MarÃa del Rosell
🇪🇸Murcia, Spain
. Hospital ClÃnico Universitario Virgen de la Victoria
🇪🇸Málaga, Spain
Complejo Asistencial Son Dureta
🇪🇸Palma de Mallorca, Spain
Hospital Verge del Toro
🇪🇸Palma de Mallorca, Spain
H. Carlos Haya
🇪🇸Málaga, Spain
ClÃnica Universitaria de Navarra
🇪🇸Pamplona, Spain
Complejo Hospitalario de Pontevedra_Hospital Montecelo
🇪🇸Pontevedra, Spain
ClÃnica Sant Camil
🇪🇸Sant Pere de Ribes, Spain
Hospital Juan Ramón Jiménez
🇪🇸Huelva, Spain
Corporació Sanità ria Parc TaulÃ
🇪🇸Sabadell, Barcelona, Spain
Hospital Germans Trias i Pujol
🇪🇸Badalona, Barcelona, Spain
Complejo Hospitalario Universitario de Albacete
🇪🇸Albacete, Spain
Complexo Hospitalario Xeral-Calde
🇪🇸Lugo, Spain
Hospital del RÃo Carrión
🇪🇸Palencia, Spain
Hospital Son Dureta
🇪🇸Palma de Mallorca, Spain
Hospital Virgen del Castillo de Yecla
🇪🇸Murcia, Spain
Hospital Son Llatzer
🇪🇸Palma de Mallorca, Spain
Hospital General de Segovia
🇪🇸Segovia, Spain
Hospital San Pedro de Alcántara
🇪🇸San Pedro de Alcántara, Spain
Hospital Universitario Marqués de Valdecilla
🇪🇸Santander, Spain
Hospital de Santiago de Compostela
🇪🇸Santiago de Compostela, Spain
H.U. Virgen del Rocio
🇪🇸Sevilla, Spain
Hospital Universitario Virgen del RocÃo
🇪🇸Sevilla, Spain
Hospital Virgen de la Salud
🇪🇸Toledo, Spain
Hospital Universitario de Canarias
🇪🇸Tenerife, Spain
Hospital Joan XXIII
🇪🇸Tarragona, Spain
Fundación Instituto Valenciano de OncologÃa
🇪🇸Valencia, Spain
Hospital ClÃnico Universitario de Valencia
🇪🇸Valencia, Spain
Hospital Francesc de Borja
🇪🇸Valencia, Spain
Hospital General Básico de la Defensa
🇪🇸Valencia, Spain
Hospital Dr. Peset
🇪🇸Valencia, Spain
Hospital ClÃnico de Valladolid
🇪🇸Valladolid, Spain
Complejo Hospitalario Universitario de Vigo
🇪🇸Vigo, Spain
Hospital General Universitario
🇪🇸Valencia, Spain
Hospital La Fe
🇪🇸Valencia, Spain
Hospital Meixoeiro
🇪🇸Vigo, Spain
Hospital de Galdakao
🇪🇸Vizcaya, Spain
Hospital ClÃnico Lozano Blesa
🇪🇸Zaragoza, Spain