Treatment of Acute Lymphoblastic Leukemia HIGH RISK BCR / ABL NEGATIVE IN ADULTS
Status:
Completed
Trial end date:
2019-12-01
Target enrollment:
Participant gender:
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