Clinical trial · Interventional
CD45RA Depleted T-cell Infusion for Prevention of Infections After TCRab/CD19-depleted Allo-HSCT
A Phase II Prospective Randomized Trial of Donor T-memory Cells (CD45RA Depleted) Infusion for Prevention of Infections After Allogeneic TcRαβ/CD19-depleted Hematopoietic Stem Cell Transplantation
NCT02942173CI-TRIAL-00064754completedPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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 prospective randomized study is to determine whether infusions of T-memory cells prevent infections in children with leukemia after allogeneic alpha, beta T-cell receptor (TcRab)/CD19-depleted hematopoietic stem cell transplantation (HSCT).
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Graft-versus-Host Disease | — | UNRESOLVED | — |
| GvHD | — | UNRESOLVED | — |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
| Opportunistic Infections | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CD45RA-depleted peripheral blood mononuclear cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- CD45RA-
- type
- EXPERIMENTAL
- label
- CD45RA+
- interventionNames
- Biological: CD45RA-depleted peripheral blood mononuclear cells
Primary outcomes (2)
- measure
- cumulative incidence of the probability of CMV-reactivation after HSCT
- timeFrame
- 120 days after HSCT
- measure
- cumulative incidence of acute GVHD grade II-IV.
- timeFrame
- 150 days after HSCT
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 25 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who are considered candidates for allogeneic hematopoietic stem cell transplantation and have one of the following diagnoses: * Acute lymphocytic leukemia (ALL) * Acute myeloid leukemia * Acute biphenotypic leukemia * Acute bilinear leukemia * Lymphoma * Myelodysplastic syndrome * Chronic myeloid leukemia * Transplant processing: TCR ab/CD19-depletion * Donors: * HLA-match unrelated volunteers * Partly and haploidentical relative Exclusion Criteria: * ALL patients not in remission * 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 * Mental disease of both patient, patient's tutor (if patient is under age 18) and donor, that hinder understanding of main point of the study and keeping treatment plan, hygiene and sanitation
References
Publications (0)
Data not yet available
No reference posted for this study.