Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Acute Lymphoblastic Leukemia
Type
Interventional
Phase
Phase 4
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 55 years and 125 years
Gender
Both males and females

Description

Prephase (days -5 to -1) Dexamethasone 10 mg/m2 bolus day IV for 5 days (-5 to -1). Supplementary treatment: hydration minimum 2000 ml/day, allopurinol 300 mg / day, gastric protection (as center), daily monitoring of blood glucose, daily monitoring of renal function. Intrathecal treatment (diagnosi...

Prephase (days -5 to -1) Dexamethasone 10 mg/m2 bolus day IV for 5 days (-5 to -1). Supplementary treatment: hydration minimum 2000 ml/day, allopurinol 300 mg / day, gastric protection (as center), daily monitoring of blood glucose, daily monitoring of renal function. Intrathecal treatment (diagnosis and prophylactic) day -5: 12 mg were administered intrathecal methotrexate. The morphological study of the CSF will be defining initial CNS involvement by LAL. Although it is recommended immunophenotypic study of CSF, the definition of CNS involvement by LAL (and its therapeutic consequences) based on morphological observation of blasts in CSF cytocentrifuge. Remission induction: Tolerance prephase period can be used to establish the final indication of treatment (standard protocol or frail patients). Day 0 is free of treatment and is considered as +1 the first day of induction. The total duration of the induction is 30 days, consists of two phases (Phase I, days +1 to +14 and phase II, days +15 to +30). Mandatory testing is considered counting the percentage of blasts in peripheral blood +8 day of induction, a myelogram to day +14 to assess early response and a day +35 to assess the complete remission (days +1 to +14) Vincristine (VCR) 1 mg (absolute dose) IV 1 and 8. Idarubicin (IDA): 10 mg (absolute dose) IV 1, 2, 8 and 9. Dexamethasone (DEX): 10 mg/m2 bolus days 1 and 2 IV, 8 to 11 days +15 to +30) cyclophosphamide (CFM): 300 mg / m 2 iV in 1 hour 15 to 17. (3 total doses). Cytarabine (ARAC): 60 mg / m 2 iV in 1 hour 16 to 19, 23 to 26. (8 total doses). Vincristine (VCR) 1 mg (absolute dose) iV 1 and 8. Idarubicin (IDA): 10 mg (absolute dose) iV 1, 2, 8 and 9. Dexamethasone (DEX): 10 mg/m2 bolus days 1 and 2 iV, 8 to 11 Consolidation: Cycles 1, 3, 5 MTX: 1,000 mg/m2, IV infusion of 24 hours day 1 L-ASA. 10,000 IU / m 2 IV or IM Day 2 Cycles 2, 4, 6 ARAC: 1,000 mg/m2, IV in 3 hours on days 1, 3 and 5

Tracking Information

NCT #
NCT01366898
Collaborators
Not Provided
Investigators
Not Provided