Status:
UNKNOWN
Chimeric Antigen Receptor (CAR)-Modified T Cell Therapy in Treating Patients With Acute Lymphoblastic Leukemia
Lead Sponsor:
Affiliated Hospital to Academy of Military Medical Sciences
Conditions:
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 chime...
Detailed Description
CAR-T has stronger effect of anti-tumor capacity. While people have been able to control the clinical complications now, so conducting CAR-T clinical trials has a strong demand and value. This study a...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT02186860
Start Date
July 1 2016
End Date
December 1 2021
Last Update
February 10 2021
Active Locations (1)
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1
Department of Hematopoietic Stem Cell Transplantation
Beijing, China, 100071