patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) after T cell depleted allo-SCT MedDRA version: 21.0 Level: LLT Classification code 10028555 Term: Myeloid leukemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1 Level: PT Classification code 10028533 Term: Myelodysplastic syndrome System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: TCM allogene humane central memory T cells, cryopreserved
Pharmaceutical Form: Solution for injection
Sponsors
University Hospital Wuerzburg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient • Male or female patients with HCT-CI score (Sorror) >= 3 AND/or Age 50 years or older • Primary or secondary AML M0, M1, M2, M4, M5, M6 and M7 in CR ( 0.5*109/L) Donor • Healthy donor - having passed medical examination for stem cell donation • Donor must fulfill the requirements for allogeneic donor blood testing according to Richtlinie zur Herstellung und Anwendung von hämatopoetischen Stammzellzubereitungen • Donor informed consent for additional non-mobilized apheresis • Written informed consent of the patient Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: Patient • Disease specific treatment foreseen in the first 6 month after HSCT • Patients with AML M3 • Pregnant or lactating women • Severe psychological disturbances • Positive serology for Human immunodeficiency virus (HIV), Syphilis, WNV • Participation in another interventional clinical trial during or within 4 weeks before study entry Additional patient exclusion criteria: Treatment phase patients at day 30 +/-5 after alloHSCT: • Disease specific treatment foreseen in the first 6 months after SCT • Acute GVHD > grade I for which immune suppressive treatment is given • Progressive disease for which therapy is needed • Use of > 0,5 mg/kg bw prednisone a day • Life expectation < 12 weeks • End stage irreversible multi-system organ failure Donor • Donor pregnant or lactating • Donors with aberrant CD45RA isoform expression • General exclusion criteria for stem cell donation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the toxicity and feasibility of prophylactic administration of donor derived central memory T Cells after T cell depleted allo-SCT;Secondary Objective: - the determination of appearance or expansion of antigen specific T cells from donor-derived TCM during 36 weeks (9 months) after the first infusion of study medication. - the evaluation of the incidence of viremia and clinical manifestations of virus related organ manifestations (CMV, EBV, Adenovirus, HSV, VZV) - Clinical signs of viral infections - Incidence of relapse - Incidence of bacterial and fungal infections - Evaluate the effect on mixed bone marrow and/or peripheral blood chimerism ;Primary end point(s): Toxicity: Cumulative incidence of acute GVHD overall grade 3 or higher within three months after infusion of the last dose of TCM Feasibility: The proportion of donors who consent to an additional apheresis procedure, and the proportion of patients that are not excluded before the transfer of the first dose of TCM on day 30 +/- 5;Timepoint(s) of evaluation of this end point: Toxicity will be evaluted on an ongoing basis. In case of acute GVHD overall grade = III in 2 out of the first 3 evaluable patients, or 3 out of the first 6 patients, or 4 out of the first 10 patients, the study will be closed temporarily for inclusions and the outcomes in all patients will be presented to the DSMB in order to decide whether potential beneficial effects of the treatment could overcome non-beneficial effects of GVHD. Efficacy will be evaluted after first fifteen procedures to isolate TCM has taken place. If out of the first fifteen procedures to isolate TCM from non-mobilized apheresis products less than 6 result in an appropriate TCM cell product which can be given to the patient, the procedure is considered to be not feasible and the study will be stopped. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - To determine the appearance or expansion of antigen specific T cells from donor-derived TCM during 36 weeks (9 months) after the infusion of study medication. - To evaluate the incidence of viremia and clinical manifestations of virus related organ manifestations (CMV, EBV, Adenovirus, HSV, VZV) - Clinical signs of viral infections - Incidence of relapse - Incidence of bacterial and fungal infections - Evaluate the effect on mixed bone marrow and/or peripheral blood chimerism ;Timepoint(s) of evaluation of this end point: Secondary objectives will be analyzed at the end of the trial | — |
Countries
Germany
Contacts
Public ContactHematology/Oncology
University Hospital Wuerzburg - Departement of Medicine II
Outcome results
None listed