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

NCT01193933 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 321

Last updated 2018-03-07

No results posted yet for this study

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

Conditions

  • Ph-negative Adult Acute Lymphoblastic Leukemia

Interventions

PROCEDURE

autologous HSCT

T-cell ALL patients recieve late consolidation with BEAM conditioning and stem cell support

Sponsors & Collaborators

  • National Research Center for Hematology, Russia

    lead NETWORK

Principal Investigators

  • Valeri G Savchenko, Professor · National Research Center for Hematology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2016-12-31
Completion
2021-12-31

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01193933 on ClinicalTrials.gov