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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.
Full description
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.
Enrollment
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Inclusion criteria
Adult and pediatric patients with hematological malignancies in complete remission (CR), partial remission (PR) or with stable disease
Acute myeloid leukemia (AML):
Acute lymphoid leukemia (ALL):
Hodgkin's disease: Patients with relapsed or primary refractory Hodgkin's disease
Non-Hodgkin's lymphoma: Patients with relapsed or primary refractory Non- Hodgkin's lymphoma
Myelodysplastic Syndrome (MDS)/ Myeloproliferative Syndrome (MPS):
°Patients with refractory MDS/MPS
Multiple myeloma (MM): Patients with relapsed or refractory multiple myeloma
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
60 participants in 1 patient group
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Central trial contact
Peter Lang, MD, PhD; Wolfgang Bethge, MD, PhD
Data sourced from clinicaltrials.gov
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