Acute Leukemias - Republican Scientific Medical Library

a 11.11 · GRAALL Trials (2003–Present) 155
Fig. 11.8. Overall outline of GRAALL-03 protocol. Abbreviations: AlloSCT,
allogeneic stem cell transplantation; ASP, L-asparaginase;
CPM, cyclophosphamide; DNR, daunorubicin; DXM, dexamethasone;
G-CSF, granulocyte colony-stimulating factor; HDAC, highdose
cytarabine; HDCPM, high-dose cyclophosphamide; HDMTX,
Fig. 11.9. Philadelphia-negative ALL: Comparison of GRAALL-03 and LALA-94 trials in terms of EFS.
augmented therapy including double delayed intensifications
in slow early responder patients [62].
Based on these results and those from the LALA-94
study, a prospective Phase 2 study (GRAALL-03) was
initiated in 2003 (Fig. 11.8). The major goals of this trial
were to increase the indications of allogeneic SCT in
both Philadelphia chromosome-negative B-lineage
ALL and T-lineage ALL depending on initial prognostic
high-dose methotrexate; HR, high-risk; IT, intrathecal; MRD, minimal
residual disease; MTX, methotrexate; PDN, prednisone; RT CNS, central
nervous system irradiation; VCR, vincristine; VP16, etoposide;
6MP, 6-mercaptopurine.
factors; to evaluate the initial response to a prephase of
corticosteroids; to evaluate the response to initial chemotherapy
evaluated on day 8 and day 28; and to define
a therapeutic strategy adapted to the evaluation of MRD.
A total of 144 patients were included between 2003 and
2005. CR was achieved in 91% of patients after one or
two chemotherapy courses. Estimated 18-month EFS
and OS were 65% and 74% respectively (Fig. 11.9) [41].