Actively Recruiting
Clinical Study of Autologous Hematopoietic Stem Cell Transplantation Combined With CD19-CART Treatment for Adult High-risk Acute Lymphoblastic Leukemia
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2024-09-23
20
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
I
Institute of Hematology & Blood Diseases Hospital, China
Lead Sponsor
J
Juventas Cell Therapy Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of autologous hematopoietic stem cell transplantation and CD19-CART therapy for adults with high-risk acute B-lymphoblastic leukemia. The study aims to observe the effectiveness and side effects of this treatment regimen and assess its safety and efficacy in managing this type of leukemia. The treatment involves first performing autologous hematopoietic stem cell transplantation, followed by transfusion of autologous CD19-CAR T cells seven days after the transplantation. This approach is being tested as a single experimental group without randomization or masking. Participants will be monitored for up to two years after transplantation. Researchers will evaluate outcomes including relapse rate, non-relapse mortality, progression-free survival, overall survival rate, and incidence of infection. Safety and treatment effects will be closely observed throughout this period.
CONDITIONS
Brief Title
Autologous Hematopoietic Stem Cell Transplantation Combined With CD19-CART Treatment of Adult High-risk Acute Lymphoblastic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients with high-risk acute B-lymphoblastic leukemia
- Complete remission achieved after induction chemotherapy
- Autologous CD19-CAR-T successfully prepared
- Eligible for autologous hematopoietic stem cell transplantation
- No major organ dysfunction
You will not qualify if you...
- Presence of malignant tumors in other organs
- Serious uncontrolled infection
- Positive for syphilis, AIDS, hepatitis B, or hepatitis C
- History of allergic reaction to study drugs or similar drugs
- Other conditions deemed unsuitable by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From transplantation day until 2 years after transplantation
Participants undergo autologous hematopoietic stem cell transplantation followed by CD19-CAR T cell transfusion 7 days after transplantation.
Regular visits during transplantation and follow-up assessments up to 2 years
Trial Site Locations
Total: 1 location
1
NO.288 Nanjing Road，Heping District，Tianjin, Tianjin,
Tianjin, Tianjin Municipality, China, 300000
Actively Recruiting
Research Team
E
erlie EL Jiang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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