Personalized Targeted Preparative Regimen Before T-depleted Allogeneic HSCT in Children With Chemoresistent Acute Leukemias
NCT04000698 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2020-11-20
Summary
The purpose of this study is to evaluate the safety and efficiency of personalized targeted therapy in combination with high-dose chemotherapy as part of a preparative regimen before T-depleted allogeneic hematopoietic stem cell transplantation in children with chemoresistant acute leukemias
Conditions
- Refractory Acute Myeloid Leukemia
- Refractory Acute Lymphoblastic Leukemia
Interventions
- DRUG
-
Preparative regimen
Preparative chemotherapy before allogeneic HSCT * Fludarabin * Cytarabine * Venetoclax * Daratumomab * Vecanoid Condition * treosulfan * fludarabine * thiophosphomide * Venetoclax * Plerixafor GVHD prophylaxis * abatacept * tocilizumab * rituximab * HSCT from the haploidentical donor, ex vivo depleted of alpha/beta T lymphocytes
Sponsors & Collaborators
-
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Max Age
- 25 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-10-15
- Primary Completion
- 2022-07-31
- Completion
- 2022-12-31
Countries
- Russia
Study Locations
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