Acute Lymphoblastic Leukemia
Conditions
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.
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 aims to evaluate the safety and efficacy of CD19-CART in treating refractory or recurrent ALL.
Interventions
BIOLOGICALCAR-T cells
Given IV
Sponsors
Affiliated Hospital to Academy of Military Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse Events | 8 weeks | To evaluate the safety of CAR-T cells in adult patients with B-acute lymphoblastic leukemia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical responses to third generation CAR-T cells | 2 years | To assess the anti-leukemic effect of CAR-T cells in adult patients with B cell-acute lymphoblastic leukemia |
Countries
China
Contacts
Primary ContactYao Sun, M.D., Ph.D.
Backup ContactLiangding Hu, M.D.
Outcome results
None listed