Clinical trial NCT03462095: De-escalated Treatment Approach for Adult Ph-negative Acute Lymphoblastic Leukemia (ALL)
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Precursor Cell Lymphoblastic Leukemia-Lymphoma
Lead sponsor: National Research Center for Hematology, Russia
Sponsor class: NETWORK
First posted: 2018-03-12
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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)

Eligibility 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

Primary outcomes:
measure: Disease-free survival
timeFrame: 5-years
Secondary outcomes:
measure: MRD-negativity after consolidation
timeFrame: 6 months
measure: Overall survival
timeFrame: 5-years
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: National Research Center for Hematology
Study officials:
affiliation: National Research Center for hematology, Moscow, Russia
name: Valeriy V Savchenko, Academician
role: STUDY_DIRECTOR
References: