Multi-centric, prospective natural history study on the frequency of infections before and after cellular therapy (INFE-CT) in patients with hematologic malignancies in comparison to the general population

Multi-centric, prospective natural history study on the frequency of infections before and after cellular therapy (INFE-CT) in patients with hematologic malignancies in comparison to the general population - INFE-CT

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00036703

Enrollment

824

Registered

2026-02-12

Start date

2026-02-26

Completion date

Unknown

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Z94.81 Z94.80

Interventions

Group 1: Patients with hematological malignancy and indication for cell therapy defined as either (I) autologous stem cell transplantation or (II) CAR T-cell therapy or (III) bispecific antibody treat

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Stated willingness to comply with all study procedures and availability for the duration of the study. Ability of subject to understand and the willingness to sign a written informed consent document. 2. Age = 18 years 3. Subject diagnosed with hematological cancer and planned to initiate one of the following treatments: I: autologous stem cell transplantation after high-dose chemotherapy II: CAR T-cell therapy III: bispecific antibody treatment

Exclusion criteria

Exclusion criteria: 1. Subjects with a diagnosis of congenital disorder of the immune system. 2. Subjects with solid tumors as indication for cellular therapy. History of solid cancer, in remission at initiation of study does not represent an exclusion criterion. 3. Previous CAR-T cell therapy or previous therapy with bispecific antibody.

Design outcomes

Primary

Measure	Time frame
Infection frequency one year before (retrospective) and at 3, 6, 9 and 12 months after cellular therapy (prospective) in patients with hematological malignancies compared to a control cohort from the general population. Schedule of activities Data collection is designed to be based on standard clinical follow-up examinations. A visit to the study centre is only mandatory for inclusion (day 0); all further examinations can be carried out remotely or by post, or at appointments based on cellular therapy (e.g. CAR-T cell therapy or stem cell transplantation).	—

Measure

Time frame

Infection frequency one year before (retrospective) and at 3, 6, 9 and 12 months after cellular therapy (prospective) in patients with hematological malignancies compared to a control cohort from the general population. Schedule of activities Data collection is designed to be based on standard clinical follow-up examinations. A visit to the study centre is only mandatory for inclusion (day 0); all further examinations can be carried out remotely or by post, or at appointments based on cellular therapy (e.g. CAR-T cell therapy or stem cell transplantation).

—

Secondary

Measure	Time frame
Comparison of infection frequency between patients after autologous hematopoietic cell transplantation, CAR-T cell therapy and bispecific antibody treatment. Comparison of infection frequency in hematological patients 3 months vs. 12 months after cellular therapy. Correlation of infection frequency with: lymphocyte subpopulations and serum immunoglobulin levels.	—

Countries

Germany

Contacts

Public ContactEva Fuhrmann-Birkle

Universitätsklinikum Freiburg

eva.fuhrmann-birkle@uniklinik-freiburg.de076127036710

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026