Chimeric Antigen Receptor (CAR)-Modified T Cell Therapy in Treating Patients With Acute Lymphoblastic Leukemia
Treatment of Chemotherapy Resistant or Refractory Acute Lymphoblastic Leukemia by Chimeric Antigen Receptor (CAR)-Modified T Cells
1 other identifier
interventional
5
1 country
1
Brief Summary
Traditional standard treatments of B cell acute lymphoblastic leukemia is not perfect for fighting cancer. Many people do not respond to the standard treatments of ALL. One possible treatment is chimeric antigen receptor (CAR) modified T cell infusions. This study aims to evaluate the safety and efficacy of novel CARTs (targeting CD19) in the treatment of refractory or recurrent ALL.The investigators start Phase I study aimed to chemotherapy resistant or refractory acute lymphoblastic leukemia patients. The purpose of this study is to assess the safety and effectiveness of CAR-T cells in patients.
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 Jul 2016
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
July 8, 2014
CompletedFirst Posted
Study publicly available on registry
July 10, 2014
CompletedStudy Start
First participant enrolled
July 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedFebruary 10, 2021
February 1, 2021
5.3 years
July 8, 2014
February 6, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Adverse Events
To evaluate the safety of CAR-T cells in adult patients with B-acute lymphoblastic leukemia
8 weeks
Secondary Outcomes (1)
Clinical responses to third generation CAR-T cells
2 years
Study Arms (1)
CAR-T cells
EXPERIMENTALTargeting CD19
Interventions
Eligibility Criteria
You may qualify if:
- Age: 18-65 years
- Patients with Cluster of Differentiation 19 (CD19) positive B cell malignancies as confirmed by flow cytometry
- Refractory or relapsed B cell-acute lymphoblastic leukemia
- No available curative treatment options (such as hematopoietic stem cell transplantation)
- Stage III-IV disease
- Creatinine \< 2.5 mg/dl
- Aspartate transaminase-alanine transaminase ratio \< 3x normal
- Bilirubin \< 2.0 mg/dl
- Karnofsky performance status \>= 60
- Expected survival time \> 3 months
- Adequate venous access for apheresis
- Ability to understand and provide informed consent
You may not qualify if:
- Pregnant or lactating women
- Patients requiring T cell immunosuppressive therapy
- Active central nervous system leukemia
- Any concurrent active malignancies
- Patients with a history of a seizure disorder or cardiac disorder
- Patients with human immunodeficiency virus, hepatitis B or C infection
- Uncontrolled active infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Hematopoietic Stem Cell Transplantation
Beijing, 100071, China
Related Publications (1)
Tang XY, Sun Y, Zhang A, Hu GL, Cao W, Wang DH, Zhang B, Chen H. Third-generation CD28/4-1BB chimeric antigen receptor T cells for chemotherapy relapsed or refractory acute lymphoblastic leukaemia: a non-randomised, open-label phase I trial protocol. BMJ Open. 2016 Dec 30;6(12):e013904. doi: 10.1136/bmjopen-2016-013904.
PMID: 28039295DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Liangding Hu, M.D.
Affiliated Hospital to Academy of Military Medical Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2014
First Posted
July 10, 2014
Study Start
July 1, 2016
Primary Completion
October 1, 2021
Study Completion
December 1, 2021
Last Updated
February 10, 2021
Record last verified: 2021-02