Clinical trial NCT04723342: 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
Overall status: RECRUITING
Phase: NA
Conditions: Childhood Acute Lymphoblastic Leukemia
Keywords: Acute lymphoblastic leukemia
Children
Chemotherapy
Immunotherapy
Blinatumomab
Lead sponsor: Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Sponsor class: OTHER
First posted: 2021-01-25
Enrollment: 180
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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:

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

Primary outcomes:
measure: Minimal residual disease level
timeFrame: On the last day of the blinatumomab course, on average at 11 weeks of protocol
measure: Minimal residual disease level
timeFrame: 6 months after starting maintenance therapy
measure: Minimal residual disease level
timeFrame: 1 year after starting maintenance therapy
measure: Event-free survival
timeFrame: 3 years after study start
measure: Event-free survival
timeFrame: 5 years after study start
Secondary outcomes:
measure: Overall survival
timeFrame: 3 years after study start
measure: Overall survival
timeFrame: 5 years after study start
measure: Cumulative incidence of relapse
timeFrame: 3 years after study start
measure: Cumulative incidence of relapse
timeFrame: 5 years after study start
measure: Remission death rate
timeFrame: 3 years after study start
measure: Remission death rate
timeFrame: 5 years after study start
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Dmitry Rogachev National Medical Research Centre of Pediatric Hematology, Oncology and Immunology
city: Moscow
country: Russian Federation
facility: National Medical Research Center of Oncology named after N.N. Blokhin
city: Moscow
country: Russian Federation
facility: Russian Children's Clinic Hospital; Pirogov Russian National Research Medical University
city: Saint Petersburg
country: Russian Federation
facility: Almazov National Medical Research Centre
Study officials:
affiliation: Federal Research Institute of Pediatric Hematology, Oncology and Immunology
name: Alexander I. Karachunskiy, Professor,MD
role: PRINCIPAL_INVESTIGATOR
References: