Follow that CAR! - A prospective observational cohort study on CAR T-cell therapy for B-cell malignancies in the Netherlands

*Follow that CAR!* - A prospective observational cohort study on CAR T-cell therapy for B-cell malignancies in the Netherlands - Follow that CAR

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON51188

Enrollment

5250

Registered

2021-11-04

Start date

2022-07-13

Completion date

Unknown

Last updated

2024-06-18

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

Conditions

leukemie en plasmacelziekten B-cell malignancies and blood- bone marrow- or lymph node cancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - 18 years or older - have a haematological B-cell malignancy - be able to read, understand and give informed consent - be referred to the CAR T-cell tumorboard for treatment eligibility screening

Exclusion criteria

Exclusion criteria: - unable to sign informed consent according to GCP guidelines

Design outcomes

Primary

Measure	Time frame
Prescreening cohort (All patients with haematological B-cell malignancies who are referred to the Dutch CAR T-cell tumorboard for treatment eligibility screening): • Information entered on tumorboard referral form - Referring center and physician - Patient characteristics and demographics - Medical history and disease characteristics - Comorbidities - Imaging results - Laboratory results - Pathology results • Evaluation by Tumorboard - Tumorboard outcome regarding eligibility (reason) • Survival and subsequent therapies (if patients are considered not eligible by the tumorboard) • Survival - Overall survival (OS) - Progression-free survival (PFS) - Time to progression - Time to death • Subsequent therapies - Description therapy (name regimen, dose, number of cycles, dates) - Response (CR, PR, SD, PD) - Duration of response (DOR) - Time to response • Cost-effectiveness - Incremental cost-effectiveness ratio (ICER) - Life years (LYs) accrued - Quality adjusted life years (QALYs) accrued Screening and treatment cohort (Patients who are considered eligible by the tumorboard for CAR T-cell therapy screening in a CAR-T treatment center): • Patient characteristics - Age - Sex - Height - Weight - Place of residence • Medical history, disease characteristics, treatment evaluation and follow-up - General medical history - Medication use - Toxicities (smoking, alcohol, drugs use) - Hematological history (diagnosis, prior treatment lines and response to treatment, risk factors such as FLIPI, MIPI, IPI score, CNS-IPI score, Ann Arbor stage, extranodal involvement, bulky disease, histological subtype) - Clinical examination (ECOG-PS, body temperature, blood pressure, heart rate, respiratory rate, oxygen saturation, B-symptoms, clinical signs of progression) - Laboratory results (haematology panel, chemistry panel, immunology panel, serology panel) - Imaging results (Response according to Lugano criteria, target- and non-targ	—

Measure

Time frame

*Prescreening cohort* (All patients with haematological B-cell malignancies who are referred to the Dutch CAR T-cell tumorboard for treatment eligibility screening): • Information entered on tumorboard referral form - Referring center and physician - Patient characteristics and demographics - Medical history and disease characteristics - Comorbidities - Imaging results - Laboratory results - Pathology results • Evaluation by Tumorboard - Tumorboard outcome regarding eligibility (reason) • Survival and subsequent therapies (if patients are considered not eligible by the tumorboard) • Survival - Overall survival (OS) - Progression-free survival (PFS) - Time to progression - Time to death • Subsequent therapies - Description therapy (name regimen, dose, number of cycles, dates) - Response (CR, PR, SD, PD) - Duration of response (DOR) - Time to response • Cost-effectiveness - Incremental cost-effectiveness ratio (ICER) - Life years (LYs) accrued - Quality adjusted life years (QALYs) accrued *Screening and treatment cohort* (Patients who are considered eligible by the tumorboard for CAR T-cell therapy screening in a CAR-T treatment center): • Patient characteristics - Age - Sex - Height - Weight - Place of residence • Medical history, disease characteristics, treatment evaluation and follow-up - General medical history - Medication use - Toxicities (smoking, alcohol, drugs use) - Hematological history (diagnosis, prior treatment lines and response to treatment, risk factors such as FLIPI, MIPI, IPI score, CNS-IPI score, Ann Arbor stage, extranodal involvement, bulky disease, histological subtype) - Clinical examination (ECOG-PS, body temperature, blood pressure, heart rate, respiratory rate, oxygen saturation, B-symptoms, clinical signs of progression) - Laboratory results (haematology panel, chemistry panel, immunology panel, serology panel) - Imaging results (Response according to Lugano criteria, target- and non-targ

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Countries

Netherlands

Outcome results