Hematological MalignanciesNCT06607289
National Longitudinal Cohort of Hematological Diseases (NICHE) - CART
An observational study of Hematological Malignancies, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hematological Malignancies
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2021to 31 Dec 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with hematologic malignancies treated with Chimeric antigen receptors (CAR) T therapy in China
Who may be able to join
- Patients with clinically diagnosed hematologic malignancies
- Patients treated with CAR-T cell therapy
- Signed the informed consent form
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, 300000
Zhen Song, MD, +86 02223909051, cir@ihcams.ac.cn
About this study
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
- Medical subject headings
- Hematologic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (3)
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.
Measured: 1 year, 2 years, 5 years
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.
Measured: 1 year, 2 years, 5 years
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.
Measured: 5 years or more
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start1 Jun 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematological MalignanciesStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06607289
- Sponsor's protocol ID
- QTJC2024047
- Status last verified
- Sep 2024
- First submitted
- 1 Sep 2024
- Last updated
- 17 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Longitudinal Cohort of Hematological Diseases (NICHE) - CART
- ClinicalTrials.gov ID
- NCT06607289
- Acronym / sponsor ID
- QTJC2024047
- Conditions
- Hematological Malignancies
- Keywords
- Chimeric antigen receptors (CAR) T cell, hematological malignancies
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 23 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with hematologic malignancies treated with Chimeric antigen receptors (CAR) T therapy in China
Key inclusion criteria (3 listed)
- Patients with clinically diagnosed hematologic malignancies
- Patients treated with CAR-T cell therapy
- Signed the informed consent form
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Long-term overall remission rate
Time frame: 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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematological Malignancies, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-term overall remission rate (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025.