Acute Lymphoblastic Leukemia Treatment Protocol Moscow-Berlin 2019 Pilot

Childhood Acute Lymphoblastic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04723342
• Other study ID #: ALL-MB 2019 Pilot
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: December 2025

Study information

• Verified date: January 2021
• Source: Federal Research Institute of Pediatric Hematology, Oncology and Immunology
• Contact: Alexander I. Karachunskiy, Professor,MD
• Phone: +7-926-218-84-09
• Email: info[@]mbstudy.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 2025
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
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	Almazov National Medical Research Centre	Saint Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
Federal Research Institute of Pediatric Hematology, Oncology and Immunology

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Minimal residual disease level		On the last day of the blinatumomab course, on average at 11 weeks of protocol
Primary	Minimal residual disease level		6 months after starting maintenance therapy
Primary	Minimal residual disease level		1 year after starting maintenance therapy
Primary	Event-free survival		3 years after study start
Primary	Event-free survival		5 years after study start
Secondary	Overall survival		3 years after study start
Secondary	Overall survival		5 years after study start
Secondary	Cumulative incidence of relapse		3 years after study start
Secondary	Cumulative incidence of relapse		5 years after study start
Secondary	Remission death rate		3 years after study start
Secondary	Remission death rate		5 years after study start