LAL-BR/2001: Study Treatment to Low Risk ALL
- Conditions
- Acute Lymphoblastic Leukemia
- Registration Number
- NCT00526175
- Lead Sponsor
- PETHEMA Foundation
- Brief Summary
The purpose of this study is increase the efficacy of consolidation (C1) after an intensification phase with high dose of methotrexate, applying analysis of minimal residual disease
- 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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
- Diagnoses of low risk acute lymphoblastic leukemia in children no treated previously
- 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 To evaluate the efficacy of treatment in order to response rate, relapse free survival and global survival 2 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (25)
Basurtuko Ospitalea
🇪🇸Basurto, Spain
Complejo Hospitalario Universitario de Albacete
🇪🇸Albacete, Spain
Hospital General de Alicante
🇪🇸Alicante, Spain
Hospital de Sant Pau
🇪🇸Barcelona, Spain
Hospital de Badalona Germans Trias i Pujol
🇪🇸Badalona, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
Complejo Hospitalario Reina Sofía
🇪🇸Córdoba, Spain
Hospital Valle Hebrón-Materno Infantil
🇪🇸Barcelona, Spain
Hospital General de Guadalajara
🇪🇸Guadalajara, Spain
Complejo Hospitalario León
🇪🇸Leon, Spain
Hospital Clínico San Carlos de Madrid
🇪🇸Madrid, Spain
. Hospital Clínico Universitario Virgen de la Victoria
🇪🇸Málaga, Spain
Complejo Asistencial Son Dureta
🇪🇸Palma de Mallorca, Spain
H.U. Virgen del Rocio
🇪🇸Sevilla, Spain
Hospital Clinico Universitario
🇪🇸Salamanca, Spain
Hospital Clínico Universitario de Salamanca
🇪🇸Salamanca, Spain
Hospital General de Segovia
🇪🇸Segovia, Spain
Hospital Joan XXIII
🇪🇸Tarragona, Spain
Hospital Arnau de Vilanova
🇪🇸Valencia, Spain
Hospital La Fe
🇪🇸Valencia, Spain
Hospital Clínic
🇪🇸Valencia, Spain
Hospital Universitario Dr. Peset
🇪🇸Valencia, Spain
Hospital Clínico de Valladolid
🇪🇸Valladolid, Spain
Complejo Hospitalario Universitario de Santiago
🇪🇸Santiago de Compostela, Spain
Hospital Clínico Lozano Blesa
🇪🇸Zaragoza, Spain