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

National Research Center for Hematology, Russia

Status: Unknown

Conditions: Precursor Cell Lymphoblastic Leukemia-Lymphoma

Treatments: Procedure: Autologous HSCT

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT03462095

ALL--2016

Details and patient eligibility

About

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.

Full 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)

Enrollment: 350 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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350 participants in 2 patient groups

no Auto-HSCT

No Intervention group

Description:

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

Auto-HSCT

Experimental group

Description:

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

Treatment:

Procedure: Autologous HSCT