National Longitudinal Cohort of Hematological Diseases (NICHE) - CART

NCT06607289 | Recruiting

• 1 other identifier: QTJC2024047
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematological Malignancies

Keywords

Chimeric antigen receptors (CAR) T cell; hematological malignancies

Outcome Measures

Primary Outcomes (1)

• Long-term overall remission rate

  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.

  5 years

Secondary Outcomes (3)

• Complete remission rate

  1 year, 2 years, 5 years

• Partial remission rate

  1 year, 2 years, 5 years

• Long-term safety

  5 years or more

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with hematologic malignancies treated with Chimeric antigen receptors (CAR) T therapy in China

You may qualify if:

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

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, 300000, China

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2024
• First Posted: September 23, 2024
• Study Start: June 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2032
• Last Updated: June 17, 2025

Record last verified: 2024-09

Locations

CN (1)