Status:
UNKNOWN
Acute Lymphoblastic Leukemia Treatment Protocol Moscow-Berlin 2019 Pilot
Lead Sponsor:
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Conditions:
Childhood Acute Lymphoblastic Leukemia
Eligibility:
All Genders
1-18 years
Phase:
NA
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 tre...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT04723342
Start Date
February 1 2020
End Date
December 1 2025
Last Update
January 25 2021
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Dmitry Rogachev National Medical Research Centre of Pediatric Hematology, Oncology and Immunology
Moscow, Russia
2
National Medical Research Center of Oncology named after N.N. Blokhin
Moscow, Russia
3
Russian Children's Clinic Hospital; Pirogov Russian National Research Medical University
Moscow, Russia
4
Almazov National Medical Research Centre
Saint Petersburg, Russia