Multicenter Clinical Trial for Adult Ph-negative ALL. Continuous Treatment With Modification of Cytostatic Drugs Doses Depending on Myelosuppression Severity

• Status: Unknown status
• Trial end date: 0000-00-00
• Target enrollment: 230
• Participant gender: Both

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Research Center for Hematology, Russia
• Treatments: Antineoplastic Agents; Asparaginase
• Last Updated: 2014-04-04

Criteria

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