B-cell Acute Lymphoblastic LeukemiaNCT06450067
Inaticabtagene Autoleucel Injection Treatment for Adult Relapsed or Refractory Acute Lymphocytic Leukemia
An observational study of B-cell Acute Lymphoblastic Leukemia, run by Juventas Cell Therapy Ltd. at 10 sites in China.
Trial summary
This clinical trial is a non-interventional, observational, multicenter, post-marketing real-world study to evaluate the efficacy and safety of Inaticabtagene Autoleucel Injection in Chinese adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B-cell Acute Lymphoblastic Leukemia
- How many people
- 200 participants
- Where
- 10 sitesChina
- Study dates
- 5 Jun 2024to 5 Jun 2029
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diagnosed with adult relapsed or refractory B-cell acute lymphoblastic leukemia.
Who may be able to join
- Age ≥ 18 years;
- Diagnosed with relapsed or refractory B-cell acute lymphoblastic leukemia;
- Patients deemed eligible for receiving commercial Inaticabtagene Autoleucel injection treatment as determined by the investigator;
- Patients voluntarily participate in this study and sign an informed consent form. For patients lacking full legal capacity, informed consent must be obtained from their legal guardian
Who cannot join
- None
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
China10 sites, 10 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100000
Meng Lv, Dr.
Meng Lv
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100000
Hongmei Jing, Dr.
Hongmei Jing
- Recruiting
West China School of Medicine/West China Hospital of Sichuan University
Chengdu, Sichuan
Ting Niu, d
Ting Niu
- Recruiting
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong
Yuhua Li, Dr.
Yuhua Li
- Recruiting
Qilu Hospital of Shandong university
Jinan, Shandong
Jun Peng, Dr.
Jun Peng
- Recruiting
Tongji Hospital of Tongji University
Shanghai, Shanghai Municipality
Aibin Liang, Dr.
Aibin Liang, Dr.
- Recruiting
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality
Jianxiang Wang, Dr.
Jianxiang Wang, Dr.
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
Heng Mei, Dr.
Heng Mei
- Recruiting
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu
Zhenyu Li, Dr.
Zhenyu Li
- Recruiting
Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University
Zhengzhou, Henan
Qingsong Yin, Dr.
Qingsong Yin
About this study
Official title: To Observe and Evaluate the Efficacy and Safety of Inaticabtagene Autoleucel Injection in the Treatment of Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia in Adults in the Real World
This clinical trial is a non-interventional, observational, multicenter, post-marketing real-world study to evaluate the efficacy and safety of Inaticabtagene Autoleucel Injection in Chinese adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia.
Read the detailed description
The study is a non-interventional, observational, multicenter, post-marketing real-world study, and its objective is to evaluate the efficacy and safety of Inaticabtagene Autoleucel Injection in the treatment of Relapsed or Refractory acute lymphoblastic leukemia. The study consists of screening period including leukapheresis, treatment period, and follow-up period (2 years at most).
- Conditions
- B-cell Acute Lymphoblastic Leukemia
- Medical subject headings
- Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Diagnosed relapsed or refractory B-cell acute lymphoblastic leukemia | Diagnosed relapsed or refractory B-cell acute lymphoblastic leukemia |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
OS is defined as the time from the start date of Inaticabtagene Autoleucel Injection infusion to the date of death due to any cause.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start5 Jun 2024
- Primary completion5 Jun 2026 (estimated)
- Study completion5 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-cell Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Juventas Cell Therapy Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianxiang Wang, Dr., Principal investigator, Institute of Hematology & Blood Diseases Hospital, ChinaAibin Liang, Dr., Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06450067
- Sponsor's protocol ID
- HY001402
- Status last verified
- Sep 2024
- First submitted
- 3 Jun 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Observe and Evaluate the Efficacy and Safety of Inaticabtagene Autoleucel Injection in the Treatment of Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia in Adults in the Real World
- ClinicalTrials.gov ID
- NCT06450067
- Acronym / sponsor ID
- HY001402
- Conditions
- B-cell Acute Lymphoblastic Leukemia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Juventas Cell Therapy Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Jun 2024 (actual)
- Primary completion
- 5 Jun 2026 (estimated)
- Study completion
- 5 Jun 2029 (estimated)
- First posted
- 10 Jun 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 clinical trial is a non-interventional, observational, multicenter, post-marketing real-world study to evaluate the efficacy and safety of Inaticabtagene Autoleucel Injection in Chinese adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia.
Detailed description
The study is a non-interventional, observational, multicenter, post-marketing real-world study, and its objective is to evaluate the efficacy and safety of Inaticabtagene Autoleucel Injection in the treatment of Relapsed or Refractory acute lymphoblastic leukemia. The study consists of screening period including leukapheresis, treatment period, and follow-up period (2 years at most).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnosed relapsed or refractory B-cell acute lymphoblastic leukemia | – | –Diagnosed relapsed or refractory B-cell acute lymphoblastic leukemia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diagnosed with adult relapsed or refractory B-cell acute lymphoblastic leukemia.
Key inclusion criteria (4 listed)
- Age ≥ 18 years;
- Diagnosed with relapsed or refractory B-cell acute lymphoblastic leukemia;
- Patients deemed eligible for receiving commercial Inaticabtagene Autoleucel injection treatment as determined by the investigator;
- Patients voluntarily participate in this study and sign an informed consent form. For patients lacking full legal capacity, informed consent must be obtained from their legal guardian
Key exclusion criteria (1 listed)
- None
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
overall survival
Time frame: 2 years
OS is defined as the time from the start date of Inaticabtagene Autoleucel Injection infusion to the date of death due to any cause.
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 19 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Jianxiang Wang, Dr. principal investigator
Institute of Hematology & Blood Diseases Hospital, China
Aibin Liang, Dr. principal investigator
Tongji Hospital
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of B-cell Acute Lymphoblastic Leukemia, run by Juventas Cell Therapy Ltd. at 10 sites 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 4 inclusion and 1 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
Contact Qinghan Wang, master (86-13439319658, 352074861@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: 2 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 19 Sep 2024.