The intestinal microbiome as a predictive biomarker for efficacy and side effects of CAR-T cell therapy in blood cancers

• Conditions: C91.0; C83.3; Acute lymphoblastic leukaemia [ALL]; Diffuse large B-cell lymphoma

• Registration Number: DRKS00020506
• Lead Sponsor: Deutsches Krebsforschungszentrum (DKFZ)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-20
• Study Completion: 2021-12-28
• Results First Posted: 2023-03-13
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

lymphoma / leukemia patients with medically indicated CD19 CAR-T cell therapy
-persons who have understood the informed consent and signed the written consent form

Exclusion Criteria

- Refusal by the patient
- Lack of ability to consent

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The main outcome is bacterial alpha diversity according to Simpson (AD) at the time of CAR-T cell therapy, which should be associated with survival within 24 months.

Secondary Outcome Measures

Name	Time	Method
Remission, Relapse, Therapy-associated toxicity [CRS, ICANS]