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

March 6, 2018 updated by: Elena N.Parovichnikova, National Research Center for Hematology, Russia

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.

  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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

321

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation
        • Russian Acute Lymphoblastic Leukemia Study group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 55 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Toxicity of prolonged L-asparaginase in adult patients
Time Frame: 3 years
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
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Research Center for Hematology, Russia

Investigators

  • Study Chair: Valeri G Savchenko, Professor, National Research Center for Hematology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

December 1, 2016

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

August 31, 2010

First Submitted That Met QC Criteria

September 1, 2010

First Posted (Estimate)

September 2, 2010

Study Record Updates

Last Update Posted (Actual)

March 7, 2018

Last Update Submitted That Met QC Criteria

March 6, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALL-2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ph-negative Adult Acute Lymphoblastic Leukemia

Clinical Trials on autologous HSCT

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Armenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe