National Longitudinal Cohort of Hematological Diseases (NICHE) - CART

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06607289

Enrollment

1000

Registered

2024-09-23

Start date

2021-06-01

Completion date

2032-12-31

Last updated

2025-06-17

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

Conditions

Hematological Malignancies

Keywords

Chimeric antigen receptors (CAR) T cell, hematological malignancies

Brief summary

This is a multicenter, ambispective, longitudinal, observational cohort study investigating CAR-T cell therapy in Chinese patients with hematological malignancies. A consortium of Phase IV clinical trials and real-world studies of Chimeric antigen receptors (CAR) T cell therapy will be established in China. Patient-level data from these studies will be collected to create a large real-world cohort. In addition, patients receiving CAR-T cell therapy for hematological malignancies identified from an existing hematology longitudinal cohort study, the National Longitudinal Cohort of Hematological Diseases (NICHE), will also be included in the study.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Patients with clinically diagnosed hematologic malignancies * Patients treated with CAR-T cell therapy * Signed the informed consent form

Design outcomes

Primary

Measure	Time frame	Description
Long-term overall remission rate	5 years	Proportion of the participants with an overall remission. To investigate the long-term efficacy of Chimeric antigen receptors (CAR) T cell therapy in Chinese patients with various hematological malignancies.

Secondary

Measure	Time frame	Description
Complete remission rate	1 year, 2 years, 5 years	Proportion of the participants with an complete remission. To investigate the long-term efficacy of Chimeric antigen receptors (CAR) T cell therapy in Chinese patients with various hematological malignancies.
Partial remission rate	1 year, 2 years, 5 years	Proportion of the participants with an partial remission. To investigate the long-term efficacy of Chimeric antigen receptors (CAR) T cell therapy in Chinese patients with various hematological malignancies.
Long-term safety	5 years or more	Number of participants with treatment-related adverse events as assessed by CTCAE v5.0. To investigate the long-term safety of Chimeric antigen receptors (CAR) T cell therapy in Chinese patients with various hematological malignancies.

Countries

China

Outcome results