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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03462095
Recruitment Status : Unknown
Verified March 2018 by National Research Center for Hematology, Russia.
Recruitment status was:  Recruiting
First Posted : March 12, 2018
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
National Research Center for Hematology, Russia

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Precursor Cell Lymphoblastic Leukemia-Lymphoma Procedure: Autologous HSCT Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 2017
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 1, 2022

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Disease-free survival [ Time Frame: 5-years ]
    Impact of autologous HSCT on DFS in T-cell ALL patients


Secondary Outcome Measures :
  1. MRD-negativity after consolidation [ Time Frame: 6 months ]
    Minimal Residual Disease clearance on non-intensive but non-interruptive treatment

  2. Overall survival [ Time Frame: 5-years ]
    Impact of de-escalated approach on OS


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03462095


Contacts
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Contact: Elena N Parovichnikova, MD,PhD +79161252623 elenap@blood.ru
Contact: Olga A Gavrilina, M.D. dr.gavrilina@mail.ru

Locations
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Russian Federation
National Research Center for Hematology Recruiting
Moscow, Russian Federation, 125167
Contact: Elena N Parovichnikova, MD PhD    +7(495)6124313    elenap@blood.ru   
Sponsors and Collaborators
National Research Center for Hematology, Russia
Investigators
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Study Director: Valeriy V Savchenko, Academician National Research Center for hematology, Moscow, Russia
More Information
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Responsible Party: National Research Center for Hematology, Russia
ClinicalTrials.gov Identifier: NCT03462095    
Other Study ID Numbers: ALL--2016
First Posted: March 12, 2018    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Each participating site has its on-line access to WEB-data base
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Once a year
Access Criteria: phone-call to coodinating center

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases