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Clinical Trials/NCT01193933
NCT01193933UnknownNot Applicable

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.

National Research Center for Hematology, Russia1 site in 1 country321 target enrollmentStarted: November 1, 2008Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
321
Locations
1
Primary Endpoint
Proportion of adult ALL patients who tolerated the non-interrupted treatment
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
15 Years to 55 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Proportion of adult ALL patients who tolerated the non-interrupted treatment

Time Frame: 3 years

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

Secondary Outcomes

  • Toxicity of prolonged L-asparaginase in adult patients(3 years)

Investigators

Sponsor Class
Network
Responsible Party
Principal Investigator
Principal Investigator

Elena N.Parovichnikova

MD PhD

National Research Center for Hematology, Russia

Study Sites (1)

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