LAL-BR/2001: Study Treatment to Low Risk ALL

2014-11-13 03:23:23 | BioPortfolio


The purpose of this study is increase the efficacy of consolidation (C1) after an intensification phase with high dose of methotrexate, applying analysis of minimal residual disease



Systemic chemotherapy:

Prednisolone (PDN):

- 60 mg/m2 day, i.v. or p.o., days 1 to 27

- 30 mg/m2 day, i.v. or p.o., days 28 to 35

Vincristine (VCR): 1,5 mg/m2 i.v., days 8, 15, 22 and 28. Daunorubicin (DNR): 30 mg/m2, i.v., days 8 and 15. L-asparaginase (L-ASA): 10.000 UI/m2, i.m. or i.v., days 9 to 11, 16 to 18 and 23 to 25.

Cyclophosphamide (CFM): 1000 mg/m2, i.v., day 22.

Intracranial chemotherapy

Methotrexate (MTX), cytosine (ARA-C) and hydrocortisone, days 1 and 22


- Mercaptopurine (MP) 50 mg/m2, p.o., days 1-7, 28-35 and 56-63

- MTX: 3g/m2, i.v., in 24 hours, days 1, 28 and 56.

- VP-16: 150 mg/m2 i.v., days 14-15 and 42-43

- ARA-C: 1000 mg/m2 i.v., in 3 hours, days 14-15 and 42-43

- Intrathecal treatment, days 1, 28 and 56.


Dexamethasone (DXM):

- 6 mg/m2 day, p.o., days 1-21

- 3 mg/m2 day, p.o. or i.v., days 22-28 VCR: 1,5 mg/m2, i.v., days 1, 8 and 15 DNR: 30 mg/m2, i.v., days 1 and 8 L-ASA: 10.000 UI/m2 i.m. or i.v., days 8 and 9, 15 and 16, 22 and 23. CFM 1000 mg/m2 day, i.v., day 22 Mercaptopurine (MP) 50 mg/m2, p.o., days 35-42 MTX: 3g/m2, i.v., in 24 hours, day 35. VP-16: 150 mg/m2 i.v., days 49-50 ARA-C: 1.000 mg/m2 i.v., in 3 hours, days 49-50 Intrathecal treatment days 1 and 35.


Continuous treatment

- MP 50 mg/m2/day, p.o.

- MTX 20 mg/m2/week, i.m.


- VCR: 1,5 mg/m2 i.v., day 1.

- PDN: 30 mg/m2/day, i.v. or p.o., days 1 to 7

- L-ASA: 20.000 UI/m2, i.m. or i.v., day 1.

- Intrathecal treatment day 1 Five cycles, weeks 24, 30, 36, 42 and 48. During the week of administration cycle, continuous chemotherapy should be suspended.

Intrathecal treatment: At the start of any reinduction cycle


- MP 50 mg/m2/day, p.o.

- MTX 20 mg/m2/week, i.m.

- Intrathecal treatment, weeks 54 and 108

At the end of treatment should be done the study of MRD (flux cytometry)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Acute Lymphoblastic Leukemia


Prednisone, Vincristine, Daunorubicin, L-Asparaginase, Cyclophosphamide, Methotrexate, Cytosine Arabinoside, Mercaptopurine, VP-16


. Hospital Clínico Universitario Virgen de la Victoria




PETHEMA Foundation

Results (where available)

View Results


Published on BioPortfolio: 2014-11-13T03:23:23-0500

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Medical and Biotech [MESH] Definitions

An enzyme that catalyzes reversibly the phosphorylation of deoxycytidine with the formation of a nucleoside diphosphate and deoxycytidine monophosphate. Cytosine arabinoside can also act as an acceptor. All natural nucleoside triphosphates, except deoxycytidine triphosphate, can act as donors. The enzyme is induced by some viruses, particularly the herpes simplex virus (HERPESVIRUS HOMINIS). EC

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An enzyme that catalyzes the transfer of a methyl group from S-ADENOSYLMETHIONINE to the 5-position of CYTOSINE residues in DNA.

Enzymes that catalyzes the transfer of a methyl group from S-ADENOSYLMETHIONINE to the 5-position of CYTOSINE residues in DNA.

An enzyme which catalyzes the deamination of CYTOSINE resulting in the formation of URACIL. It can also act on 5-methylcytosine to form THYMIDINE.

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