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

NCT03462095 | Unknown DMC

• 1 other identifier: ALL--2016
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Outcome Measures

Primary Outcomes (1)

• Disease-free survival

  Impact of autologous HSCT on DFS in T-cell ALL patients

  5-years

Secondary Outcomes (2)

• MRD-negativity after consolidation

  6 months

• Overall survival

  5-years

Study Arms (2)

no Auto-HSCT

NO INTERVENTION

After completing prolonged consolidation T-cell ALL patients will continue with 2 years maintenance

Auto-HSCT

EXPERIMENTAL

After completing prolonged consolidation T-cell ALL patients will get autologous HSCT followed by 2 years maintenance

Procedure: Autologous HSCT

Interventions

Autologous HSCT PROCEDURE

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

Auto-HSCT

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National Research Center for Hematology, Russia: lead

Study Sites (1)

National Research Center for Hematology

Moscow, 125167, Russia

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Valeriy V Savchenko, Academician

  National Research Center for hematology, Moscow, Russia

  STUDY DIRECTOR

Central Study Contacts

Elena N Parovichnikova, MD,PhD

CONTACT

+79161252623; elenap@blood.ru

Olga A Gavrilina, M.D.

CONTACT

dr.gavrilina@mail.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2018
• First Posted: March 12, 2018
• Study Start: January 1, 2017
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2022
• Last Updated: March 13, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Once a year
• Access Criteria: phone-call to coodinating center

Locations

RU (1)