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

Bridging therapy of acute lymphoblastic leukemia before treatment with chimeric antigen receptor (CAR) T cells - Retrospective analysis for a guidance - ALL-Bridge 2 CAR

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00024916

Enrollment

Registered

2021-05-26

Start date

2021-06-01

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

C91.0

Interventions

Group 1: non-interventional retrospective observational study

Eligibility

Sex/Gender

All

Age

No minimum to 30 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
• 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 • 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	—

Measure

Time frame

• 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 • 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

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

Measure

Time frame

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

—

Countries

Austria, Germany, Switzerland

Contacts

Public ContactRamona Krauß

Dr von Haunersches Kinderspital, Abteilung für Hämatologie und Onkologie

Ramona.Krauss@med.uni-muenchen.de0049 (0)89 4400 52990

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026