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Meta-analysis of the safety of Chimeric Antigen Receptor (CAR) T-Cell Therapy for hematological malignancies

Meta-analysis of the safety of Chimeric Antigen Receptor (CAR) T-Cell Therapy for hematological malignancies - Meta-analysis of the safety of Chimeric Antigen Receptor (CAR) T-Cell Therapy for hematological malignancies

Status
Active, not recruiting
Phases
Unknown
Study type
Unknown
Source
JPRN
Registry ID
JPRN-UMIN000052420
Enrollment
Unknown
Registered
2023-10-05
Start date
2023-10-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Hematological Malignancies

Interventions

None listed

Sponsors

Yokohama City University Graduate School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Only parallel-group RCTs will be included, and only English-language literature will be included. Include short reports and conference abstracts. Non-inferiority trials are acceptable alongside superiority trials. RCTs of any phase may be included. Exclude trials that do not report safety data. The main inclusion criteria are as follows. (1) Trials in adult patients with hematological malignancies. (2) RCTs including CAR-T therapy. (3) Trials with adverse event results (cytokine release syndrome, neurotoxicity, infection, hypogammaglobulinemia, infusion reaction, cytopenia, macrophage activation syndrome/hemophagocytic lymphohistiocytosis, coagulopathy, tumor lysis syndrome).

Exclusion criteria

Exclusion criteria: (1) Systematic review or meta-analysis articles. (2) Non-RCT. (3) The republished research literature is excluded unless the research includes new findings related to adverse events listed in inclusion criteria. (4) Trials with no or insufficient safety outcomes at the time of the literature search.

Design outcomes

Primary

MeasureTime frame
The primary outcome is the frequency of occurrence of cytokine release syndrome and neurotoxicity during the observation period.

Secondary

MeasureTime frame
Secondary outcomes are the frequency of infections, hypogammaglobulinemia, infusion reactions, cytopenia, macrophage activation syndrome/hemophagocytic syndrome, coagulopathy, and tumor lysis syndrome over the observation period.

Countries

Japan

Contacts

Public ContactKaoru Minegishi

Yokohama City University Graduate School of Medicine Department of Stem Cell and Immune Regulation

kaoru_t@yokohama-cu.ac.jp045-787-2630

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026