Bridging therapy of acute lymphoblastic leukemia before treatment with chimeric antigen receptor (CAR) T cells - Retrospective analysis for a guidance

Recruiting

Conditions: C91.0
Acute lymphoblastic leukaemia [ALL]

Registration Number: DRKS00024916

Lead Sponsor: Dr. von Haunersches Kinderspital Klinikum der Universität München

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 35

Inclusion Criteria

Patients until age of 30 suffering from relapsed/refractory B-lineage ALL with the decision to initiate CAR T-cell therapy. This age was chosen based on the approved age limit of 25 for the current CAR T-cell products with market authorization. It was extended to 30 to also take into account individual cases of curative treatments.

Exclusion Criteria

Patients treated with CAR T-cells within the scope of a clinical study have to be excluded in case of conflict of interest with the sponsor.

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
• Bridging therapy (agent and cumulative dose) and assessment of progression of ALL and side effects between the time point of identifying an eligible patient (f.e. tumor board decision or health insurance request) and the time point of the leukapheresis<br>• Bridging therapy (agent and cumulative dose) and assessment of progression of ALL and side effects from the time point of the leukapheresis until the start of the CAR T cell therapy or drop-out

Secondary Outcome Measures

Name	Time	Method
• Age and sex<br>• Previous cellular treatment (SCT, DLI or other)<br>• Time from decision to CAR T-cell therapy until treatment<br>• Disease burden (%ALL blasts or MRD) at time of decision for CD19CAR T-cell therapy <br>• Disease burden (%ALL blasts or MRD) at time of leukapheresis<br>• Disease burden (%ALL blasts or MRD) at time start of lymphodepletion<br>• Time to start of CAR T cell therapy<br>• Rate of CAR T cell implementation<br>• Complete description of reasons for not implementing CAR T cell therapy (bridging related/not related) <br>• Observation of rates of toxicities and severity (bridging related/not related)<br>• Severe infections (bacterial, viral, fungal) and time point of occurrence <br>• Hematologic toxicities (Neutropenia, thrombopenia and duration)<br>• Severe other toxicities of bridging therapy<br>• Survival <br>• Karnovsky/Lansky score at start and end of bridging therapy