Clinical trial · Interventional
Risk-adapted Donor Lymphocyte Infusion After Allo-HSCT in Children With Hematologic Malignancy
Study of the Efficacy and Safety of Risk-adapted Donor Lymphocyte Infusions for the Prophylaxis and Prevention of Relapses After Allogeneic Hematopoietic Stem Cell Transplantation in Children and Adolescent With Hematologic Malignancy
- 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)
Allo-hsct is potentially curative method of treatment for children and adolescent with hematologic malignancy. However, relapses of disease after allo-hsct occur up to 50% of patients and constitute the main cause of mortality after HSCT. Donor lymphocytes infusion (DLI) is a form of immunotherapy based on developement of reaction "graft versus from leukemia". This study evaluates the safety and efficacy of risk-adapted srtategy of DLI for prophylaxis and prevention posttransplant relapses in children and adolescent with hematologic malignancy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Preventive Donor lymphocytes infusions | Biological | — | UNRESOLVED |
| Prophylactic Donor lymphocytes infusions | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Prophylactic
- description
- The patients with high risk of relapse of disease and full donor chimerism after allo-HSCT without signs of the disease will be include in this group.
- interventionNames
- Biological: Prophylactic Donor lymphocytes infusions
- type
- EXPERIMENTAL
- label
- Preventive
- description
- The patients with persisted minimal residual disease or cytogenetic relapse after allo-HSCT will be include in this group.
- interventionNames
- Biological: Preventive Donor lymphocytes infusions
Primary outcomes (1)
- measure
- Relapse - free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 4 Months
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 4 months - 18 years old * Diagnosis: acute lymphoblastic leukemia, acute myeloid leukemia, juvenile myelomonocytic leukemia, myelodysplastic syndrome, chronic myeloid leukemia * Signed by legal representatives informed consent * High risk disease ( for ALL - initial hyperleukocytosis\> 50x109 / L, T-cell ALL, hypodiploid karyotype, complex karyotype, MLL gene rearrangement, SIL-TAL deletion, primary resistent of the disease, early/very earle relapse, infant ALL; for AML patients - rearrangement of the MLL gene (except for t (1; 11) and t (9; 11) with M5 morphology), inv (3), t (3; 3), complex karyotype anomalies, t (8; 21 ) with trisomy 4, t (16; 21), monosomy 7, monosomy 5, M7 without t (1; 22), FLT3+, M6, t (7; 12), AML with multilineage dysplasia, p53 gene mutations, NUP98 translocations, primary resistent of the disease, early/very earle relapse infant AML, secondary AML; all juvenile myelomonocytic leukemia and myelodysplastic syndrome; allo-HSCT at 3 or more remission; persistence MRD before alloHSCT; allo-HSCT out of remission; persistence MRD after alloHSCT; cytogenetic relapse after alloHSCT ) * Donor chimerism=\>95% * No poor graft function (haemoglobin concentration \< 100 g/L; neutrophils \< 1.0 × 10E + 9/L; and platelets \< 30 × 10E + 9/L on day ≥ 30 post transplant with complete donor chimerism and no graft-versus-host disease or relapse ) * ECOG 0-2 status * Karnofsky/Lansky status \>30% Exclusion Criteria: * Uncontrolled bacterial or fungal infection at the time of enrollment * Severe organ failure: creatinine more than 2 norms; ALT, AST more than 5 norms; bilirubin more than 1.5 norms * Ejection fraction less than 50% * Requirement for vasopressor support at the time of enrollment * Somatic or psychiatric disorder making the patient unable to sign an informed consent * Acute GVHD grade 3-4 in patient medical history * Severe chronic GVHD in patient medical history
References
Publications (0)
Data not yet available