Clinical and biological follow-up of children and young adutls prior to, during, and after CAR T-cell therapy, prospective single-centre study (CABRIO)

Clinical and biological follow-up of children and young adutls prior to, during, and after CAR T-cell therapy, prospective single-centre study (CABRIO) - CABRIO: learning from CAR T-cell therapy to make better use of it

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON57230

Enrollment

Registered

2025-01-09

Start date

2025-10-23

Completion date

Unknown

Last updated

2025-11-17

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

Conditions

CAR T-cell therapy Cellular therapy Immune therapy

Interventions

None listed

Eligibility

Age

No minimum to 64 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: 1. Age 0-26 years 2. Intention to start CAR T-cell treatment in Princess Máxima Center 3. Signed written informed consent 4. Stratum specific inclusion criteria • Stratum A: tisagenlecleucel in standard of care treatment for BCP-ALL • Other strata will be amended after market approval • Strata for patients in clinical studies will be amended

Exclusion criteria

Exclusion criteria: No informed consent obtained

Design outcomes

Primary

Measure	Time frame
The primary endpoint of the study is to characterize and quantify changes in the immune response during CAR T-cell treatment.	—

Secondary

Measure	Time frame
Secondary endpoints will include the impact of fludarabine levels on the immune profile, CAR T-cell expansion, CAR T-cell persistence and quality of life.	—

Countries

Netherlands

Outcome results