National Longitudinal Cohort of Hematological Diseases (NICHE) - CART

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with clinically diagnosed hematologic malignancies

Patients treated with CAR-T cell therapy

Signed the informed consent form

Disqualifiers

None

Trial population

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

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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.

Time frame
5 years

Secondary outcomes

1

Complete remission rate

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.

Time frame
1 year, 2 years, 5 years
2

Partial remission rate

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.

Time frame
1 year, 2 years, 5 years
3

Long-term safety

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.

Time frame
5 years or more

Other outcomes

Sponsors and contacts

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