Donation of donor T lymphocytes (TCM) after stem cell transplantation, which are specificly directed against multiple pathogenic organism or body tissue

Phase 1

• Conditions: patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) after T cell depleted allo-SCT; MedDRA version: 21.0Level: LLTClassification code 10028555Term: Myeloid leukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10028533Term: Myelodysplastic syndromeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2015-001522-41-DE
• Lead Sponsor: niversity Hospital Wuerzburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-03
• Last Update Posted: 13 September 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 25

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 (<5% blasts in BM) irrespective of the cytogenetic or molecular risk profile or MDS up to RAEB-2 (maximal 20% blasts in bone marrow)
• Planned alloHSCT with CD34+-purified stem cell grafts after conditioning with fludarabin-melphalan-thio-thepa-ATG
• HLA-matched stem cell donor (9-10/10, maximal 1 allel- or antigen mismatch allowed) without aberrant CD45RA expression
• Donor must have met requirements of EU Tissue and Cells Directive (2004/23/EC) as (see below)
Additional patient inclusion criteria: Treatment phase patients at day 30 +/-5 after alloHSCT:
• Stable engraftment of the allogeneic graft (granulocytes > 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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified