Autologous Hematopoietic Stem Cell Transplantation Combined With CD19-CART Treatment of Adult High-risk Acute Lymphoblastic Leukemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Autologous hematopoietic stem cell transplantation combined with CD19-CART.
- Who it may be relevant to
- Registry conditions: Acute Lymphoblastic Leukemia ALL. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical Study of Autologous Hematopoietic Stem Cell Transplantation Combined With CD19-CART Treatment for Adult High-risk Acute Lymphoblastic Leukemia
Overview
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
- Biological Autologous hematopoietic stem cell transplantation combined with CD19-CART
Autologous CD19-CAR T cells were transfused +7 days after autologous hematopoietic stem cell transplantation
Primary outcome measures
- Relapse rate within 2 years [Time frame: Time Frame: From autologous hematopoietic stem cell transplantation to 2 years after transplantation]
Secondary outcome measures (4)
- Non-relapse mortality [Time frame: Time Frame: From autologous hematopoietic stem cell transplantation to 2 years after transplantation]
- Progression-free survival [Time frame: Time Frame: From autologous hematopoietic stem cell transplantation to 2 years after transplantation]
- Overall survival rate [Time frame: Time Frame: From autologous hematopoietic stem cell transplantation to 2 years after transplantation]
- Incidence of infection [Time frame: Time Frame: From autologous hematopoietic stem cell transplantation to 2 years after transplantation]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- NO.288 Nanjing Road，Heping District，Tianjin, Tianjin, — Tianjin
Identifiers
NCT: NCT06608342 · IIT2024036