Clinical trial · Interventional
Personalized Targeted Preparative Regimen Before T-depleted Allogeneic HSCT in Children With Chemoresistent Acute Leukemias
A Phase I-II Pilot Clinical Trial of Safety and Efficacy of Personalized Targeted Preparative Regimen With Allogeneic TcRαβ/CD19-depleted Hematopoietic Stem Cell Transplantation and Posttransplant Donor T- Cells Infusion in Children With Chemoresistаnt Acute Leukemia.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Refractory Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.78 |
| Refractory Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Preparative regimen | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- intervention/treatment
- description
- Preparative chemotherapy before allogeneic HSCT * Fludarabin * Cytarabine * Venetoclax * Daratumomab * Vecanoid * treosulfan * fludarabine * thiophosphomide * Venetoclax * Plerixafor * abatacept * tocilizumab * rituximab * HSCT from the haploidentical donor, ex vivo depleted of alpha/beta T lymphocytes
- interventionNames
- Drug: Preparative regimen
Primary outcomes (5)
- measure
- cumulative incidence of neutrophil and platelets engraftment at day +30 after HSCT
- timeFrame
- 30 days after HSCT
- measure
- Overall response rate
- timeFrame
- 30 days after HSCT
- description
- Proportion of patients with hematologic remission at time points
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 25 Years
Show eligibility criteria text
Inclusion Criteria: 1. Ability to give informed consent (for patients \> 14 years old). For subjects \< 18 years old their legal guardian must give informed consent 2. Disease stage * Acute myeloid leukemia (AML), relapsed or refractory, failure to achieve hematologic remission after at least to courses of intensive chemotherapy, including at least one course with high-dose AraC and fludarabine * Acute lymphoblastic leukemia (ALL), relapsed or refractory, failure to achieve hematologic remission after at least two high-dose therapy blocks 3. Patient eligible for current hematopoietic stem cell transplantation protocol 4. The BCL-2 expression must be detected on greater than 30% of tumor cells (AML and ALL) by flow cytometry 5. CD38 expression must be detected on greater than 30% of tumor cells (AML and ALL) by flow cytometry 6. CD184 7. Patients must have measurable or evaluable disease at the time of enrollment, which may include any evidence of disease including minimal residual disease detected by flow cytometry, cytogenetics, or polymerase chain reaction (PCR) analysis. 8. Patient Clinical Performance Status: Karnofsky \>50% or Lansky \>50% 9. Patient Life Expectancy \>12 weeks 10. Patients who agree to long-term follow up for up to 5 years Exclusion Criteria: * Age \>25 years * Patients with uncontrolled infections * Clearance of creatinine \< 70 ml/min * Cardiac ejection fraction \< 40% * Patients who can perform pulmonary function tests will be excluded if they have a diffusing capacity of the lung for carbon monoxide (DLCO) (corrected for hemoglobin) of \< 50% predicted; patients who are unable to perform pulmonary function tests will be excluded if the oxygen (O2) saturation is \< 92% on room air * Patients who have liver function test (LFTs) (including total bilirubin, aspartate aminotransferase \[AST\] and alanine aminotransferase \[ALT\]) \>= twice the upper limit of normal * Karnofsky/Lansky Scale \<70%
References
Publications (0)
Data not yet available