MRD-associated Non-intensive But Non-interruptive Treatment of Ph-negative Acute Lymphoblastic Leukemia Adult Patients

Precursor Cell Lymphoblastic Leukemia-Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06237192
• Other study ID #: RALL-2016m
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: September 1, 2027

Study information

• Verified date: January 2024
• Source: National Research Center for Hematology, Russia
• Contact: Olga Aleshina, MD, PhD
• Phone: +79629745058
• Email: dr.gavrilina[@]mail.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 1, 2027
• Est. primary completion date: September 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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,

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• blinatumomab for B-ALL, venetoclax for T-ALL
MRD-associated based therapy for Ph-negative acute lymphoblastic leukemia

Locations

Country	Name	City	State
Russian Federation	Olga Aleshina	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	Rate of Diseases-free survival in MRD-positive ALL patients	3-year
Secondary	MRD-negativity after target therapy	Rate of Minimal Residual Disease negativity after target therapy	1 month
Secondary	Overall survival	Rate of overall survival in protocol	3-yaers OS