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.
15 Years
55 Years
Both
Ph-negative Adult Acute Lymphoblastic Leukemia
Trial Information
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. 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.
Inclusion Criteria:
- Ph-negative precursors ALL
- age 15-55 years
- nontreated
- Eastern Cooperative Oncology Group criterion status 0-3
Exclusion Criteria:
- B-mature ALL
- Ph-positivity
- pretreatment
- Eastern Cooperative Oncology Group criterion status 4
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Proportion of adult ALL patients who tolerated the non-interrupted treatment
Outcome Description:
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
Outcome Time Frame:
3 years
Safety Issue:
Yes
Principal Investigator
Valeri G Savchenko, Professor
Investigator Role:
Study Chair
Investigator Affiliation:
National Research Center for Hematology
Authority:
Russia: Ministry of Health of the Russian Federation
Study ID:
ALL-2009
NCT ID:
NCT01193933
Start Date:
November 2008
Completion Date:
December 2014
Related Keywords:
- Ph-negative Adult Acute Lymphoblastic Leukemia
- adult ALL
- Ph-negative
- dexamethasone
- L-asparaginase
- Leukemia
- Leukemia, Lymphoid
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
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