adult patients with hematological malignancies in first or second remission who are eligible and scheduled for allogeneic / autologous peripheral blood stem cell transplantation or for administration of cell therapies (e. g. ATMPs)
Conditions
Interventions
Group 1: non-interventional observational study with biobanking
Sponsors
Fraunhofer-Institut für Zelltherapie und Immunologie
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: adult patients with hematological malignancies in first or second remission who are eligible and scheduled for allogeneic / autologous peripheral blood stem cell transplantation or for administration of cell therapies (e. g. ATMPs) signed written informed consent (donor / patient) age = 18 years, = 70 years
Exclusion criteria
Exclusion criteria: none
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| epidemiological parameters (number of reported cases per): - time (incidence, prevalence), - age, - gender, - classification according to the type of underlying disease - karyotype, immunophenotype, molecular characteristics response, recurrence and time of death and resulting survival Outcomes Proportion of patients achieving immune cell engraftment Proportion of patients with therapy-limiting toxicity (TLT) after immune cell engraftment, as determined by Safety Review Committee (SRC) / Data Safety Monitoring Board (DSMB) General aim of the observation: The trial aims to document epidemiologic data, treatment and long-term outcome as well as quality of life of patients with hematological malignancies. Additionally, a biobanking project for further translational studies is integrated. | — |
Secondary
| Measure | Time frame |
|---|---|
| time to immune reconstitution (IR) complete remission (CR) treatment related mortality (TRM) cumulative incidence of relapse (CIR) cumulative incidence of death (CID) cumulative incidence of non-relapse survival cumulative incidence of disease relapse / progression grade I-IV toxicities cumulative incidence of grade I to IV acute graft-versus-host disease (GvHD) cumulative dose and duration of steroid medication for the treatment of GvHD cumulative incidence of extensive chronic GvHD quality of life (QoL): EQ-5D-5L Disease-/ progression-free survival (DFS/PFS) | — |
Countries
Germany
Contacts
Public ContactPhilipp Lückemeier
Universitätsklinikum Leipzig Klinik und Poliklinik für Hämatologie, Zelltherapie und HämostaseologieBereich Hämatologie und Zelltherapie
Outcome results
None listed