Neoplasms

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Precursor Cell Lymphoblastic Leukemia-Lymphoma

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Hematologic Diseases

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Immunoproliferative Disorders

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Hydrocortisone

Hydrocortisone 17-butyrate 21-propionate

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Cytarabine

Fludarabine

Fludarabine phosphate

Dexamethasone

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Vincristine in induction:5 mg/m2 i.v. days 1, 8, 15 and 22 in induction phase Daunorubicin in induction 45 mg/m2 i.v. days 1, 8, 15 and 22 Prednisone in induction: 60 mg/m2/ day, i.v. o p.o., days 1 to 14; 30 mg/m2/day, i.v. o p.o., days 15 to 21; 15 mg/m2/day i.v. o p.o., days 21 to 28 Metotrexato 12 mg days 1 and 22 (intrathecal) Cytarabine (ARA-C): 30 mg days 1 and 22 (intrathecal) Hydrocortisone: 20 mg days 1 and 22 (intrathecal) Idarubicin-induction 2 12 mg/m2, i.v., days 1, 3 and 5 Fludarabine in induction-2: Fludarabine 30 mg/m2, i.v., days, 1 to 5

Vincristine in induction

Daunorubicin in induction

Prednisone in induction

Metotrexato in induction

Cytarabine in induction

Hydrocortisone in induction

Idarubicin in induction-2

Fludarabine in induction-2

Ara-C in induction-2

G-CSF in induction-2

Dexamethasone in consolidation-1

Vincristrine in consolidation-1

Metotrexato in consolidation-1

PEG-ASP in consolidation-1

Dexamethasone in consolidation-2

ARA-C in consolidation-2

PEG-ASP in consolidation-2

Dexamethasone in consolidation-3

Vincristine in consolidation-3

Metotrexato in consolidation-3

PEG-ASP in consolidation-3

allogeneic HSCT

Allo HSCT with reduced-intensity conditioning

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

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

Improve the results of the protocol ALL-AR-03 with modifications in the study methodology of residual disease: centralized, Biomed protocols and the cut-off - \<0.01% - internationally accepted and changes in the induction and consolidation treatment, without altering the overall design

Determination of minimal residual disease in a central laboratory trying to homogenice the results

To assess whether the reduction of daunorubicin in induction and changes in the consolidation drugs reduce toxic mortality in patients in complete remission

PETHEMA Foundation

Spots Global Cancer Trial Database for metotrexato in induction