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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03462095
Other study ID # ALL--2016
Secondary ID
Status Recruiting
Phase N/A
First received March 6, 2018
Last updated March 12, 2018
Start date January 2017
Est. completion date December 1, 2022

Study information

Verified date March 2018
Source National Research Center for Hematology, Russia
Contact Elena N Parovichnikova, MD,PhD
Phone +79161252623
Email elenap@blood.ru
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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)


Recruitment information / eligibility

Status Recruiting
Enrollment 350
Est. completion date December 1, 2022
Est. primary completion date December 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Russian Federation National Research Center for Hematology Moscow

Sponsors (1)

Lead Sponsor Collaborator
National Research Center for Hematology, Russia

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary Disease-free survival Impact of autologous HSCT on DFS in T-cell ALL patients 5-years
Secondary MRD-negativity after consolidation Minimal Residual Disease clearance on non-intensive but non-interruptive treatment 6 months
Secondary Overall survival Impact of de-escalated approach on OS 5-years
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