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

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

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

Sponsors & Collaborators

• PETHEMA Foundation

  lead OTHER

Eligibility

Min Age

15 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-02-29

Primary Completion

2019-11-20

Completion

2019-12-01

Countries

• Spain

Study Locations