Acute Lymphoblastic Leukemia
Conditions
Keywords
Acute Lymphoblastic Leukemia, Minimal Residual Disease
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)
Interventions
DRUGPrednisone
60 mg/m2 day, i.v. or oral, dyas 1 to 27 30 mg/m2 day, i.v. or oral, days 28 to 35
DRUGVincristine
1,5 mg/m2 i.v., days 8, 15, 22 and 28
DRUGDaunorubicin
30 mg/m2, i.v., days 8 and 15
DRUGL-Asparaginase
10.000 UI/m2, i.m. or i.v., days 9 to 11, 16 to 18 and 23 to 25. Total: 9 doses.
DRUGCyclophosphamide
1000 mg/m2, i.v., day 22.
DRUGMethotrexate
Age \<1 year 1-2 years 2-3 years \> 3 years MTX 5 mg 8 mg 10 mg 12 mg
Edad \<1 year 1-2 years 2-3 years \> 3 years ARA-C 16 mg 16 mg 20 mg 30 mg
DRUGMercaptopurine
50 mg/m2,oral, days 1 to 7, 28-35 and 56-63
DRUGVP-16
150 mg/m2 i.v., days 14-15 and 42-43
Sponsors
PETHEMA Foundation
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 15 Years
Healthy volunteers
No
Inclusion criteria
* Diagnoses of low risk acute lymphoblastic leukemia in children no treated previously
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of treatment in order to response rate, relapse free survival and global survival | 2 years |
Countries
Spain
Outcome results
None listed