NCT01540812

Treatment of Acute Lymphoblastic Leukemia HIGH RISK BCR / ABL NEGATIVE IN ADULTS

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 418 (actual)
• Sponsor: PETHEMA Foundation · Academic / Other
• Sex: All
• Age: 15 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Trial protocol intended the optimization of induction treatment with: 1. Inclusion of PEG-ASP in induction and in the three blocks of consolidation. 2. Reduction of the dose of daunorubicin, and recent studies have shown that the use of high doses of anthracyclines has not brought higher response rates or longer duration 3. Replacing the poor cytological response at day 14 by the level of ER at the end of induction as a criterion to decide the further treatment (consolidation or second induction), so as to have only one criterion (the ER) throughout the study to decision making. For another hand, reducing non-essential drugs consolidation blocks to try to reduce toxicity during it, and replace the ASP E. coli in induction and consolidation of PEG-ASP to ensure a more sustained asparagine depletion. Also, increasing the dose of methotrexate (3 to 5 g/m2) in patients with ALL-T, since there is recent evidence of a higher response rate with this strategy. Performing an allo-HSCT early (after one cycle of consolidation) for patients with inadequate level of ER after two cycles of induction or in those patients who required two courses of induction and have obtained proper ER after the second. Conducting studies of RD centrally by cytofluorometry following Euroflow consensus standards, to avoid bias in making treatment decisions

Conditions

• Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
DRUG	Vincristine in induction
DRUG	Daunorubicin in induction
DRUG	Prednisone in induction
DRUG	Metotrexato in induction
DRUG	Cytarabine in induction
DRUG	Hydrocortisone in induction
DRUG	Idarubicin in induction-2
DRUG	Fludarabine in induction-2
DRUG	Ara-C in induction-2
DRUG	G-CSF in induction-2
DRUG	Dexamethasone in consolidation-1
DRUG	Vincristrine in consolidation-1
DRUG	Metotrexato in consolidation-1
DRUG	PEG-ASP in consolidation-1
DRUG	Dexamethasone in consolidation-2
DRUG	ARA-C in consolidation-2
DRUG	PEG-ASP in consolidation-2
DRUG	Dexamethasone in consolidation-3
DRUG	Vincristine in consolidation-3
DRUG	Metotrexato in consolidation-3
DRUG	PEG-ASP in consolidation-3
PROCEDURE	allogeneic HSCT
PROCEDURE	Allo HSCT with reduced-intensity conditioning

Timeline

• Start date: 2012-02-01
• Primary completion: 2019-11-20
• Completion: 2019-12-01
• First posted: 2012-02-29
• Last updated: 2020-03-09

Locations

1 site across 1 country: Spain