Survey of hematologic-immunological reconstitution and outcome of patients with hematological malignancies after allogeneic and / or autologous cell therapy

Recruiting

• Conditions: 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)

• Registration Number: DRKS00022444
• Lead Sponsor: Fraunhofer-Institut für Zelltherapie und Immunologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-22
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 200

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

none

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
epidemiological parameters (number of reported cases per): <br>- time (incidence, prevalence), <br>- age,<br>- gender,<br>- classification according to the type of underlying disease<br>- karyotype, immunophenotype, molecular characteristics<br><br>response, recurrence and time of death and resulting survival Outcomes<br><br>Proportion of patients achieving immune cell engraftment<br><br>Proportion of patients with therapy-limiting toxicity (TLT) after immune cell engraftment, as determined by Safety Review Committee (SRC) / Data Safety Monitoring Board (DSMB)<br><br>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 Outcome Measures

Name	Time	Method
time to immune reconstitution (IR)<br>complete remission (CR)<br>treatment related mortality (TRM)<br>cumulative incidence of relapse (CIR)<br>cumulative incidence of death (CID)<br>cumulative incidence of non-relapse survival<br>cumulative incidence of disease relapse / progression<br>grade I-IV toxicities<br>cumulative incidence of grade I to IV acute graft-versus-host disease (GvHD)<br>cumulative dose and duration of steroid medication for the treatment of GvHD<br>cumulative incidence of extensive chronic GvHD<br>quality of life (QoL): EQ-5D-5L<br>Disease-/ progression-free survival (DFS/PFS)