CAR-T Therapy for Central Nervous System B-cell Acute Lymphocytic Leukemia
1 other identifier
interventional
10
1 country
1
Brief Summary
This study will evaluates the safety and efficacy of Chimeric antigen receptor T cells (CAR-T) in treating central nervous system B-cell acute lymphocytic leukemia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Mar 2017
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 18, 2017
CompletedFirst Posted
Study publicly available on registry
February 27, 2017
CompletedStudy Start
First participant enrolled
March 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedNovember 29, 2023
November 1, 2023
7.8 years
February 18, 2017
November 27, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The complete remission (CR) rate
The safety of the humanized CD19 CAR-T cells treatment will be evalated and the maximum tolerated dose will be determined
Participants will be followed for the duration of the treatment, an expected average of 12 months
Study Arms (1)
Arm 1
EXPERIMENTALCD19 CAR-T cells treated central nervous system B-cell acute lymphocytic leukemia.
Interventions
CNS leukemia is defined as unequivocal evidence of leukemic blasts in the cerebrospinal fluid by cytology or flow cytometry; cranial palsies or a nonhemorrhagic mass seen in cranial computed tomography or magnetic resonance imaging because of infiltration by leukemia cells
Eligibility Criteria
You may qualify if:
- Patients with CD19 positive central nervous system B-cell acute lymphocytic leukemia
- ALT/ AST 《 3x normal
- Creatinine 《 3x normal
- Age:10-60.
- Signed informed consent
You may not qualify if:
- Active hepatitis B , hepatitis C or HIV infection
- Uncontrolled active infection
- Pregnancy or breast-feeding women
- Survival less than four weeks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital of Soochow University
Suzhou, China
Related Publications (1)
Chen LY, Kang LQ, Zhou HX, Gao HQ, Zhu XF, Xu N, Yu L, Wu DP, Xue SL, Sun AN. Successful application of anti-CD19 CAR-T therapy with IL-6 knocking down to patients with central nervous system B-cell acute lymphocytic leukemia. Transl Oncol. 2020 Nov;13(11):100838. doi: 10.1016/j.tranon.2020.100838. Epub 2020 Jul 31.
PMID: 32745961DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sheng-Li Xue, Ph.D
The First Affiliated Hospital of Soochow University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Masking Details
- Open Label
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2017
First Posted
February 27, 2017
Study Start
March 1, 2017
Primary Completion
December 31, 2024
Study Completion
December 31, 2025
Last Updated
November 29, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share