Acute Lymphoblastic Leukemia Treatment Protocol Moscow-Berlin 2019 Pilot

Sponsor

Federal Research Institute of Pediatric Hematology, Oncology and Immunology (Other)

Overall Status

Recruiting

CT.gov ID

NCT04723342

Collaborator

(none)

180

Enrollment

Locations

Arm

Anticipated Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Childhood Acute Lymphoblastic Leukemia	Drug: Blinatumomab	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

180 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Treatment of Children and Adolescents With Primary B-precursor Acute Lymphoblastic Leukemia With Combination Chemotherapy and Immunotherapy

Actual Study Start Date :

Feb 1, 2020

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Blinatumomab Consolidation therapy with Blinatumomab administration	Drug: Blinatumomab Blinatumomab, intravenously, as continuous 24 hours infusion 1-7 days - 5 μg/m2/day, 8-28 day - 15 μg/m2/day 1 course after induction treatment

Arm

Intervention/Treatment

Experimental: Blinatumomab

Consolidation therapy with Blinatumomab administration

Drug: Blinatumomab

Blinatumomab, intravenously, as continuous 24 hours infusion 1-7 days - 5 μg/m2/day, 8-28 day - 15 μg/m2/day 1 course after induction treatment

Outcome Measures

Primary Outcome Measures

Minimal residual disease level [On the last day of the blinatumomab course, on average at 11 weeks of protocol]
Minimal residual disease level [6 months after starting maintenance therapy]
Minimal residual disease level [1 year after starting maintenance therapy]
Event-free survival [3 years after study start]
Event-free survival [5 years after study start]

Secondary Outcome Measures

Overall survival [3 years after study start]
Overall survival [5 years after study start]
Cumulative incidence of relapse [3 years after study start]
Cumulative incidence of relapse [5 years after study start]
Remission death rate [3 years after study start]
Remission death rate [5 years after study start]

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

Age at diagnosis at 1 to 18 years.
The start of induction therapy within a time interval of study recruitment phase.
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).
CD19 expression on tumor cells.
Informed consent of the patient parents (guardians)

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	Country
1	Dmitry Rogachev National Medical Research Centre of Pediatric Hematology, Oncology and Immunology	Moscow	Russian Federation
2	National Medical Research Center of Oncology named after N.N. Blokhin	Moscow	Russian Federation
3	Russian Children's Clinic Hospital; Pirogov Russian National Research Medical University	Moscow	Russian Federation
4	Almazov National Medical Research Centre	Saint Petersburg	Russian Federation