Autologous Hematopoietic Stem Cell Transplantation Combined With CD19-CART Treatment of Adult High-risk Acute Lymphoblastic Leukemia
Phase 2
Recruiting
- Conditions
- Acute Lymphoblastic Leukemia ALL
- Interventions
- Biological: Autologous hematopoietic stem cell transplantation combined with CD19-CART
- Registration Number
- NCT06608342
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Autologous hematopoietic stem cell transplantation combined with CD19-CART Autologous hematopoietic stem cell transplantation combined with CD19-CART -
- Primary Outcome Measures
Name Time Method Relapse rate within 2 years Time Frame: From autologous hematopoietic stem cell transplantation to 2 years after transplantation
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
NO.288 Nanjing Road，Heping District，Tianjin, Tianjin,
🇨🇳Tianjin, Tianjin, China