Back to resultsAcute Lymphoblastic Leukemia Treatment Protocol Moscow-Berlin 2019 Pilot
Primary Purpose
Childhood Acute Lymphoblastic Leukemia
Status
Recruiting
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Blinatumomab
Sponsored by
About this trial
This is an interventional treatment trial for Childhood Acute Lymphoblastic Leukemia focused on measuring Acute lymphoblastic leukemia, Children, Chemotherapy, Immunotherapy, Blinatumomab
Eligibility Criteria
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
Sites / Locations
- Dmitry Rogachev National Medical Research Centre of Pediatric Hematology, Oncology and ImmunologyRecruiting
- National Medical Research Center of Oncology named after N.N. BlokhinRecruiting
- Russian Children's Clinic Hospital; Pirogov Russian National Research Medical UniversityRecruiting
- Almazov National Medical Research CentreRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Blinatumomab
Arm Description
Consolidation therapy with Blinatumomab administration
Outcomes
Primary Outcome Measures
Minimal residual disease level
Minimal residual disease level
Minimal residual disease level
Event-free survival
Event-free survival
Secondary Outcome Measures
Overall survival
Overall survival
Cumulative incidence of relapse
Cumulative incidence of relapse
Remission death rate
Remission death rate
Full Information
NCT ID
NCT04723342
First Posted
January 19, 2021
Last Updated
January 22, 2021
Sponsor
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
1. Study Identification
Unique Protocol Identification Number
NCT04723342
Brief Title
Acute Lymphoblastic Leukemia Treatment Protocol Moscow-Berlin 2019 Pilot
Official Title
Treatment of Children and Adolescents With Primary B-precursor Acute Lymphoblastic Leukemia With Combination Chemotherapy and Immunotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Acute Lymphoblastic Leukemia
Keywords
Acute lymphoblastic leukemia, Children, Chemotherapy, Immunotherapy, Blinatumomab
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Blinatumomab
Arm Type
Experimental
Arm Description
Consolidation therapy with Blinatumomab administration
Intervention Type
Drug
Intervention Name(s)
Blinatumomab
Intervention Description
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
Primary Outcome Measure Information:
Title
Minimal residual disease level
Time Frame
On the last day of the blinatumomab course, on average at 11 weeks of protocol
Title
Minimal residual disease level
Time Frame
6 months after starting maintenance therapy
Title
Minimal residual disease level
Time Frame
1 year after starting maintenance therapy
Title
Event-free survival
Time Frame
3 years after study start
Title
Event-free survival
Time Frame
5 years after study start
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
3 years after study start
Title
Overall survival
Time Frame
5 years after study start
Title
Cumulative incidence of relapse
Time Frame
3 years after study start
Title
Cumulative incidence of relapse
Time Frame
5 years after study start
Title
Remission death rate
Time Frame
3 years after study start
Title
Remission death rate
Time Frame
5 years after study start
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander I. Karachunskiy, Professor,MD
Phone
+7-926-218-84-09
Email
info@mbstudy.net
First Name & Middle Initial & Last Name or Official Title & Degree
Julia V. Roumiantseva, MD, PhD
Phone
+7-903-730-39-78
Email
j.roumiantseva@mbstudy.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander I. Karachunskiy, Professor,MD
Organizational Affiliation
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dmitry Rogachev National Medical Research Centre of Pediatric Hematology, Oncology and Immunology
City
Moscow
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
National Medical Research Center of Oncology named after N.N. Blokhin
City
Moscow
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Russian Children's Clinic Hospital; Pirogov Russian National Research Medical University
City
Moscow
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Almazov National Medical Research Centre
City
Saint Petersburg
Country
Russian Federation
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Acute Lymphoblastic Leukemia Treatment Protocol Moscow-Berlin 2019 Pilot
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