1. evaluation of blast clearance in b/m after 7 days of prednisolone prephase and the efficacy of its substitution by dexamethasone if blast count is 25% and more 2. feasibility for adults of "no interruptions" protocol with 8 weeks induction and 14 weeks consolidation followed by 2-years maintenance. 3. tolerability and efficacy in adults of the prolonged L-asparaginase application (total proposed dose 560.000 IU) 4. feasibility and efficacy of autologous stem cell transplantation for T-cell ALL
1. The blast count in b/m after 7 days of prednisolone \>25% was shown in 64% of patients. The substitution of prednisolone by dexamethasone did not influence survival. 2. "no interruptions" induction was performed in 48% of patients. 3. In 19% of patients the L-asparaginase therapy was stopped due to toxicity. 4. Autologous stem cell transplantation was done in 20% of T-cell ALL patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
321
T-cell ALL patients recieve late consolidation with BEAM conditioning and stem cell support
Russian Acute Lymphoblastic Leukemia Study group
Moscow, Russia
Proportion of adult ALL patients who tolerated the non-interrupted treatment
Number of patients who finished the protocol without any deviation, who were off the protocol due to toxicity, in whom the treatment schedule was modified and respectively the antileukemia efficacy in those subgroups
Time frame: 3 years
Toxicity of prolonged L-asparaginase in adult patients
Number of patients who tolerated the scheduled L-asparaginase by dose and time sequence, proportion of patients shifted to PEG-asparaginase, in whom L-asparaginase was stopped and, respectively, the survival without leukemia of those patients
Time frame: 3 years
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