MedDRA - 10018651: GVHD
Conditions
Interventions
Group 1: Adult Patients with haematological malignancies receiving stem cell transplantation from matched unrelated donors which are in therapy for prevention of graft-versus-host disease (GvHD) in co
Sponsors
Neovii Biotech GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: • Written informed consent • Patients suffering from hematological malignancies • Patients designated to undergo allogeneic bone marrow or peripheral blood stem cell transplantation from matched unrelated donors who will receive GvHD prevention according to ATG-F SPC • Physician’s therapy decision is independent from inclusion
Exclusion criteria
Exclusion criteria: • Patients who formerly underwent transplantation including previous autologous transplantation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| GvHD and relapse- free survival, defined as survival free of severe GvHD and free of relapse within 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| • Engraftment until months 12 • aGvHD (acute GvHD) until months 12 • cGvHD (chronic GvHD) until months 12 • Relapse until months 12 • Relapse mortality until months 12 • Non-relapse mortality until months 12 • Disease-free survival until months 12 • Overall survival until months 12 • New malignancies until months 12 • Immunosuppressive therapy until months 12 • Quality-of-life (EQ-5d questionnaire at day 100 and months 12) • Resource consumption until months 12 • Safety: Adverse Drug reactions (ADR), serious ADR (SADR), severe infections until months 12 | — |
Countries
Germany
Contacts
Public ContactRalf Tostmann
Universitätsklinikum Freiburg
Outcome results
None listed