National Longitudinal Cohort of Hematological Diseases (NICHE) - CART
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Hematological Malignancies. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Long-term overall remission rate [Time frame: 5 years]
Secondary outcome measures (3)
- Complete remission rate [Time frame: 1 year, 2 years, 5 years]
- Partial remission rate [Time frame: 1 year, 2 years, 5 years]
- Long-term safety [Time frame: 5 years or more]
Eligibility criteria
Inclusion criteria
- Patients with clinically diagnosed hematologic malignancies
- Patients treated with CAR-T cell therapy
- Signed the informed consent form
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Institute of Hematology & Blood Diseases Hospital — Tianjin
Identifiers
NCT: NCT06607289 · QTJC2024047