Clinical trial NCT06237192: MRD-associated Non-intensive But Non-interruptive Treatment of Ph-negative Acute Lymphoblastic Leukemia Adult Patients
Official title: Multicenter Prospective Study of Safety and Efficacy MRD-associated Non-intensive But Non-interruptive Treatment of Ph-negative Acute Lymphoblastic Leukemia Adult Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Precursor Cell Lymphoblastic Leukemia-Lymphoma
Lead sponsor: National Research Center for Hematology, Russia
Sponsor class: NETWORK
First posted: 2024-02-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Non-intensive But Non-interruptive Treatment based on previously study RALL-2016 of Adult Ph-negative Acute Lymphoblastic Leukemia: 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 remission (CR) with MRD-positive status after 2nd induction receive consolidation 1-3 with venetoclax (56 days), and B-ALL patients in complete remission (CR) with MRD-positive status after 2nd induction receive 1 consolidation with blinatumomab. After that consolidation bone samples are collected and tested for MRD and patients will continue therapy by protocol without HSCT if MRD-negative (by flow cytometry by aberrant immunophenotype in a centralized lab) status was achieved.

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 and B-ALL patients are being study MRD (by FCM) MRD-positive patients with T-ALL will receive 1-3 consolidation with venetoclax (400 mg/d), and B-ALL patients will receive1 additional consolidation by blinatumomab
* Non-interruptive 5 consolidation phases with dose modification according to WBC and platelets count after CR achievement. Rotation of consolidation is permitted
* 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 allo-HSCT
* Allo-HSCT is planned only for very high risk patients (11q23 ALL, MRD positivity after target therapy, ETP T-ALL)

Eligibility criteria: Inclusion Criteria:

• age 18-55 years old of patient,

- Clinical diagnosis of non-treated Ph-negative ALL

Exclusion Criteria:

• age more than 55 years old,

* Clinical diagnosis of Ph-positive ALL
* Clinical diagnosis of relapsed/refractory ALL,

Primary outcomes:
measure: Disease-free survival
timeFrame: 3-year
Secondary outcomes:
measure: MRD-negativity after target therapy
timeFrame: 1 month
measure: Overall survival
timeFrame: 3-yaers OS
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Olga Aleshina
Study officials:
affiliation: National Research Medical Center for Hematology
name: Elena Parovichnikova, MD, PhD
role: STUDY_DIRECTOR
References: