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

This study is currently recruiting participants.
Verified October 2012 by National Research Center for Hematology, Russia
Sponsor:
Information provided by (Responsible Party):
Elena N.Parovichnikova, National Research Center for Hematology, Russia
ClinicalTrials.gov Identifier:
NCT01193933
First received: August 31, 2010
Last updated: October 19, 2012
Last verified: October 2012
History of Changes
  Purpose
  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

Condition Intervention
Ph-negative Adult Acute Lymphoblastic Leukemia
 Drug: L-asparaginase

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Research Center for Hematology, Russia:

Primary Outcome Measures:
  • Proportion of adult ALL patients who tolerated the non-interrupted treatment [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Toxicity of prolonged L-asparaginase in adult patients [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Number of patients who tolerated the scheduled L-asparaginase by dose and time sequence, proportion of patients shifted to PEG-asparaginase, in whom L-asparaginase was stopped and, respectively, the survival without leukemia of those patients


Estimated Enrollment: 170
Study Start Date: November 2008
Estimated Study Completion Date: December 2014
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: L-asparaginase
    prolonged L-asparaginase application at 10.000 IU weekly in induction, once in two weeks in 14 weeks consolidation, twice a month in maintenance (total proposed dose 560.000 IU)
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.
  Eligibility

Ages Eligible for Study:   15 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01193933

Contacts
Contact: Elena N Parovichnikova, Ass Prof +7-495-612-43-13 elenap@blood.ru

Locations
Russian Federation
Russian Acute Lymphoblastic Leukemia Study group Recruiting
Moscow, Russian Federation
Contact: Elena N Parovichnikova, Ass Prof     +7-495-612-43-13     elenap@blood.ru    
Principal Investigator: Julia R Davidyan, MD            
Sub-Investigator: Olga Yu Baranova, MD            
Sub-Investigator: Tatyana I Kaporskaya, MD            
Sub-Investigator: Elena V Kondakova, MD            
Sub-Investigator: Tatyana V Ryltzova, MD            
Sub-Investigator: Sergey N Bondarenko, MD            
Sub-Investigator: Andrey N Sokolov, MD PhD            
Sponsors and Collaborators
National Research Center for Hematology, Russia
Investigators
Study Chair: Valeri G Savchenko, Professor National Research Center for Hematology
  More Information

No publications provided

Responsible Party: Elena N.Parovichnikova, MD PhD, National Research Center for Hematology, Russia
ClinicalTrials.gov Identifier: NCT01193933     History of Changes
Other Study ID Numbers: ALL-2009
Study First Received: August 31, 2010
Last Updated: October 19, 2012
Health Authority: Russia: Ministry of Health of the Russian Federation

Keywords provided by National Research Center for Hematology, Russia:
adult ALL
Ph-negative
dexamethasone
L-asparaginase

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents
Asparaginase
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013