Optimizing treatment for childhood acute lymphoblastic leukemia

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

This study is testing if adding a new type of antibody treatment to the care of children with a specific type of leukemia can improve their outcomes while using less chemotherapy and seeing if they can finish treatment in just one year.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 1 Year to 18 Years
• Sex: All
• Sponsor: Federal Research Institute of Pediatric Hematology, Oncology and Immunology (other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 4 sites (Moscow and 3 other locations)
• Trial ID: NCT04723342 on ClinicalTrials.gov

What this trial studies

This study aims to enhance the treatment of children and adolescents with primary B-cell precursor acute lymphoblastic leukemia (BCP-ALL) by integrating monoclonal bispecific antibodies, specifically Blinatumomab, into the post-induction therapy while simultaneously reducing chemotherapy. The study will evaluate the efficacy and safety of this combined approach compared to standard chemotherapy. It also seeks to determine if the duration of maintenance therapy can be shortened to one year without compromising treatment effectiveness. The research is conducted across several clinics in Moscow.

Who should consider this trial

Good fit: Ideal candidates are children and adolescents aged 1 to 18 years diagnosed with B-cell precursor acute lymphoblastic leukemia.

Not a fit: Patients with severe concomitant diseases or those whose ALL is a second malignancy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more effective and less toxic treatment options for children with acute lymphoblastic leukemia.

How similar studies have performed: Other studies have shown promising results with similar immunotherapy approaches in treating acute lymphoblastic leukemia, indicating potential for success in this study.

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

Where this trial is running

Moscow and 3 other locations

• Dmitry Rogachev National Medical Research Centre of Pediatric Hematology, Oncology and Immunology — Moscow, Russian Federation (RECRUITING)
• National Medical Research Center of Oncology named after N.N. Blokhin — Moscow, Russian Federation (RECRUITING)
• Russian Children's Clinic Hospital; Pirogov Russian National Research Medical University — Moscow, Russian Federation (RECRUITING)
• Almazov National Medical Research Centre — Saint Petersburg, Russian Federation (RECRUITING)

Study contacts

• Principal investigator: Alexander I. Karachunskiy, Professor,MD — Federal Research Institute of Pediatric Hematology, Oncology and Immunology
• Study coordinator: Alexander I. Karachunskiy, Professor,MD

Conditions: Childhood Acute Lymphoblastic Leukemia, Acute lymphoblastic leukemia, Children, Chemotherapy, Immunotherapy, Blinatumomab