Ph-negative Adult Acute Lymphoblastic Leukemia Clinical Trial
Official title:
Multicenter Clinical Trial for Adult Ph-negative ALL. Evaluation of the Impact of the Prolonged L-asparaginase Therapy During Continuous Treatment With Modification of Cytostatic Drugs Doses Depending on Myelosuppression Severity.
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.
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