The purpose of this clinical trial is to examine safety and toxicity of CD45RA depleted donor lymphocyte infusion (DLI) after transplantation of TCRα/β/CD19 depleted peripheral blood stem cells.
Patients will undergo routine reduced intensity conditioning regimen and intravenous infusion of T-cell receptor alpha/beta (TCRα/β)/CD19 depleted peripheral blood stem cells (not content of clinical trial). If no graft-versus-host disease (GVHD) occurs, patients receive the trial-related memory T cell donor lymphocyte infusion (DLI) on Day 30 after transplantation. In a dose finding part (phase I) escalating doses will be applied in cohorts of three (three plus three design) patients with a maximum of 18 patients for three dose levels (dose level 1-3). A fourth lower dose level (dose level 0) is started, if \>=2 out of 6 patients with dose level 1 develop aGVHD III/IV. The maximum tolerated dose (MTD) will be used for the confirmatory part (phase II) of the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
CD45RA depleted donor lymphocyte infusion (DLI) after TCRα/β depleted haploidentical HCT
University Children's Hospital University Clinic Tuebingen
Tübingen, Germany
RECRUITINGUniversity Hospital Tuebingen, Department of Hematology, Oncology, Immunology and Rheumatology
Tübingen, Germany
RECRUITINGPhase I, dose escalation
Safety and toxicity of CD45RA depleted DLI as defined by infusional toxicities and acute GVHD grad III-IV.
Time frame: 100 days
Phase II, extension phase
Acute graft-versus-host disease grade III-IV defined as GVHD occurring within 100 days after HCT
Time frame: 100 days
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