De-escalated Treatment Approach for Adult Ph-negative Acute Lymphoblastic Leukemia (ALL)

March 12, 2018 updated by: National Research Center for Hematology, Russia

Non-intensive But Non-interruptive Treatment of Adult Ph-negative Acute Lymphoblastic Leukemia With Randomization for Maintenance or Autologous Hematopoietic Stem Cell Transplantation (HSCT) Followed by Maintenance in T-cell ALL Patients

No high-dose methotrexate (MTX) and high-dose cytarabine (ARA-C) consolidation blocks, L-asparaginaseis scheduled for 1 year of treatment, 21 intrathecal injections through the whole treament, T-ALL patients in complete remossion (CR) after the informed consent are randomized to: auto-HSCT vs no auto-HSCT, - with the similar further maintenance. Stem cell harvest is performed after the 3rd consolidation by G-SCF disregarding minimal residual disease (MRD) level. Auto-HSCT is planned after the 5th consolidation phase. All primary bone samples are collected and tested for cytogenetics and molecular markers, all included patients are monitored by flow cytometry by aberrant immunophenotype in a centralized lab.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

  • 7 days prednisolone prephase

  • 8 weeks induction with de-escalation of induction chemotherapy: 3 instead of 4 dauno/vncr pulses,

    1. instead of 2 Cph injections during induction,
    2. instead of 4 ARA-C blocks, distribution of of L-asp injections through all phases
  • After CR achievement T-cell ALL patients are being randomized to auto-HSCT vs no auto-HSCT
  • Non-interruptive 5 consolidation phases with dose modification according to WBC and platelets count after CR achievement. Rotation of consolidation is permitted
  • After the 3rd consolidation stem cells harvesting is carried out for T-cell ALL patients randomized to auto-HSCT
  • Auto-HSCT after the 5th consolidation phase with non-myeloablative CEAM conditioning
  • 2 years maintenance for all patients
  • 21 TIT through the whole treatment with higher intensity during induction|consolidation
  • Centralized MRD monitoring at +70 d, + 133 d, + 190 days; before and after auto-HSCT
  • Allo-HSCT is planned only for very high risk patients (11q23 ALL, MRD positivity at day +190)

Study Type

Interventional

Enrollment (Anticipated)

350

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 Contact

  • Name: Elena N Parovichnikova, MD,PhD
  • Phone Number: +79161252623
  • Email: elenap@blood.ru

Study Contact Backup

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 125167
        • Recruiting
        • National Research Center for Hematology
        • Contact:
          • Elena N Parovichnikova, MD PhD
          • Phone Number: +7(495)6124313
          • Email: elenap@blood.ru

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

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age 18-55 yy, newly diagnosed non-treated Ph-negative ALL

Exclusion Criteria:

  • age > 55 yy, Ph-positivity, relapsed|refractory ALL, pretreated ALL

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: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: no Auto-HSCT
After completing prolonged consolidation T-cell ALL patients will continue with 2 years maintenance
Experimental: Auto-HSCT
After completing prolonged consolidation T-cell ALL patients will get autologous HSCT followed by 2 years maintenance
Procedure: Autologous HSCT
After the 3rd consolidation, T-cell ALL patients, randomized to auto-HSCT will be mobilised by G-SCF and harvested disregarding MRD-status. After completing the 5th consolidation T-ALL patients will be transplanted after non-myeloablative CEAM (CCNU, Ethoposide, ARA-C, Melphalan) conditioning, and after reconstitution will continue 2-years maintenance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free survival
Time Frame: 5-years
Impact of autologous HSCT on DFS in T-cell ALL patients
5-years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MRD-negativity after consolidation
Time Frame: 6 months
Minimal Residual Disease clearance on non-intensive but non-interruptive treatment
6 months
Overall survival
Time Frame: 5-years
Impact of de-escalated approach on OS
5-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 Director: Valeriy V Savchenko, Academician, National Research Center for hematology, Moscow, Russia

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 (Actual)

January 1, 2017

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

March 6, 2018

First Submitted That Met QC Criteria

March 6, 2018

First Posted (Actual)

March 12, 2018

Study Record Updates

Last Update Posted (Actual)

March 13, 2018

Last Update Submitted That Met QC Criteria

March 12, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALL--2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Each participating site has its on-line access to WEB-data base

IPD Sharing Time Frame

Once a year

IPD Sharing Access Criteria

phone-call to coodinating center

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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