Acute Lymphoblastic Leukemia Treatment Protocol Moscow-Berlin 2019 Pilot

Not Applicable

Recruiting

• Conditions: Childhood Acute Lymphoblastic Leukemia
• Interventions: Drug: Blinatumomab

• Registration Number: NCT04723342
• Lead Sponsor: Federal Research Institute of Pediatric Hematology, Oncology and Immunology

Brief Summary

THE PURPOSE OF THE STUDY is to optimize the therapy of patients with primary B-cell precursor acute lymphoblastic leukemia (BCP-ALL) by including monoclonal bispecific antibodies in post-induction treatment with simultaneous reduction of chemotherapy.

QUESTIONS AND OBJECTIVES OF THE STUDY:

* to determine the efficacy and feasibility of chemotherapy and immunotherapy combination in comparison with standard PCT in children and adolescents with newly diagnosed BCP-ALL;

* to determine the safety and toxicity of chemotherapy and immunotherapy combination in comparison with standard PCT in children and adolescents with newly diagnosed BCP-ALL;

* to determine the possibility of chemotherapy reducing when immunotherapy is included in the treatment regimen without loss of effectiveness;

* to determine the possibility of reducing the maintenance therapy duration to 1 year when immunotherapy is included in the treatment regimen without loss of effectiveness.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-01
• Status Verified: 2021-01
• Study First Submitted: 2021-01-19
• Study First Submitted QC: 2021-01-22
• Last Update Submitted: 2021-01-22
• Study First Posted: 2021-01-25
• Last Update Posted: 2021-01-25
• Primary Completion: 2022-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

This study included patients with B-cell precursor ALL (BCP-ALL) diagnosed or confirmed in one of the clinics participating in the study. Also following criteria should be considered at the diagnosis for each case:

1. Age at diagnosis at 1 to 18 years.
2. The start of induction therapy within a time interval of study recruitment phase.
3. The diagnosis of BCP-ALL is to be proved by the morphological, cytochemical, and immunological analysis of tumor cells in bone marrow in the reference laboratories of Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology (D. Rogachev NMRCPHOI).
4. CD19 expression on tumor cells.
5. Informed consent of the patient parents (guardians)

Exclusion Criteria

1. Any non-compliance with the inclusion criteria.
2. ALL is a second malignancy.
3. There is severe concomitant disease, which significantly impedes chemotherapy protocol (such as multiple malformations, heart diseases, metabolic disorders, etc.);
4. The patient was treated before for a long time with cytotoxic drugs.
5. Initial CNS (central nervous system) involvement (status CNSII or CNSIII).
6. Initial leukocyte count ≥100×109/L (except for patients with significant translocations).
7. Patients not achieved cytological remission after induction

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Blinatumomab	Blinatumomab	Consolidation therapy with Blinatumomab administration

Primary Outcome Measures

Name	Time	Method
Minimal residual disease level	1 year after starting maintenance therapy
Event-free survival	5 years after study start

Secondary Outcome Measures

Name	Time	Method
Overall survival	5 years after study start
Remission death rate	5 years after study start
Cumulative incidence of relapse	5 years after study start

Trial Locations

Locations (4)

Almazov National Medical Research Centre; 🇷🇺 Saint Petersburg, Russian Federation

Dmitry Rogachev National Medical Research Centre of Pediatric Hematology, Oncology and Immunology; 🇷🇺 Moscow, Russian Federation

National Medical Research Center of Oncology named after N.N. Blokhin; 🇷🇺 Moscow, Russian Federation

Russian Children's Clinic Hospital; Pirogov Russian National Research Medical University; 🇷🇺 Moscow, Russian Federation