Acute Lymphoblastic Leukemia ALL
Conditions
Keywords
inaticabtagene autoleucel, auto-HSCT
Brief summary
To observe the efficacy and side effects of autologous hematopoietic stem cell transplantation combined with CD19-CART for adult acute lymphoblastic leukemia, and to evaluate the safety and efficacy of this regimen in the treatment of acute lymphoblastic leukemia.
Detailed description
To observe the efficacy and side effects of autologous hematopoietic stem cell transplantation combined with CD19-CART for adult acute lymphoblastic leukemia, and to evaluate the safety and efficacy of this regimen in the treatment of acute lymphoblastic leukemia.
Interventions
BIOLOGICALAutologous hematopoietic stem cell transplantation combined with CD19-CART
Autologous CD19-CAR T cells were transfused +7 days after autologous hematopoietic stem cell transplantation
Sponsors
Institute of Hematology & Blood Diseases Hospital, China
Juventas Cell Therapy Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients with high-risk acute B-lymphoblastic leukemia * Complete remission was achieved after induction chemotherapy, and autologous CD19-CAR-T was successfully prepared * Eligible for autologous hematopoietic stem cell transplantation * No major organ dysfunction
Exclusion criteria
* Combined with malignant tumors of other organs * With a serious infection that is not under control * Syphilis, AIDS, hepatitis B, hepatitis C, any one of them positive * Patients who have had an allergic reaction to the drugs used in this study or similar drugs * Other patients deemed unsuitable for inclusion by the investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relapse rate within 2 years | Time Frame: From autologous hematopoietic stem cell transplantation to 2 years after transplantation |
Secondary
| Measure | Time frame |
|---|---|
| Non-relapse mortality | Time Frame: From autologous hematopoietic stem cell transplantation to 2 years after transplantation |
| Progression-free survival | Time Frame: From autologous hematopoietic stem cell transplantation to 2 years after transplantation |
| Overall survival rate | Time Frame: From autologous hematopoietic stem cell transplantation to 2 years after transplantation |
| Incidence of infection | Time Frame: From autologous hematopoietic stem cell transplantation to 2 years after transplantation |
Countries
China
Contacts
Primary Contacterlie EL Jiang
Outcome results
None listed