NCT01193933

Multicenter Clinical Trial for Adult Ph-negative ALL. Non-intensive But Non-iterruptive Treatment

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.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 321 (estimated)
• Sponsor: National Research Center for Hematology, Russia · Network
• Sex: All
• Age: 15 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Ph-negative Adult Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
PROCEDURE	autologous HSCT	T-cell ALL patients recieve late consolidation with BEAM conditioning and stem cell support

Timeline

• Start date: 2008-11-01
• Primary completion: 2016-12-01
• Completion: 2021-12-01
• First posted: 2010-09-02
• Last updated: 2018-03-07

Locations

1 site across 1 country: Russia