Treatment of High Risk Adult Acute Lymphoblastic Leukemia
HR ALL included one or more of the following baseline parameters: age 30-60 yr, WBC count
>25x109/L and 11q23 or MLL rearrangements. Induction therapy included vincristine,
prednisone and daunorubicin for 4 weeks. In pts with slow cytologic response to therapy
(≥10% blasts in bone marrow assessed on d14) intensified induction with high dose ARA-C and
mitoxantrone was administered. Early consolidation therapy included 3 cycles with rotating
cytotoxic drugs including high-dose methotrexate, high-dose ARA-C and high-dose
asparaginase. Pts. with slow cytologic response on d14 or MRD level >0.05% after
consolidation were assigned to allogeneic SCT (related or unrelated) and those with standard
cytologic response on d14 and MRD level <0.05% after consolidation received 3 additional
cycles of delayed consolidation (identical to those of early consolidation) followed by
maintenance therapy up to 2yr in CR.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the response to a differentiated therapy (chemotherapy or allogeneic SCT) according to early bone marrow blast clearance and MRD levels in HR Ph- adult ALL patients.
Ribera Josep Mª, Dr
Spain: Ministry of Health