Autologous Hematopoietic Stem Cell Transplantation Combined With CD19-CART Treatment of Adult High-risk Acute Lymphoblastic Leukemia
Clinical Study of Autologous Hematopoietic Stem Cell Transplantation Combined With CD19-CART Treatment for Adult High-risk Acute Lymphoblastic Leukemia
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jun 2024
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 25, 2024
CompletedFirst Submitted
Initial submission to the registry
September 6, 2024
CompletedFirst Posted
Study publicly available on registry
September 23, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 30, 2028
September 23, 2024
September 1, 2024
1.9 years
September 6, 2024
September 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Relapse rate within 2 years
Time Frame: From autologous hematopoietic stem cell transplantation to 2 years after transplantation
Secondary Outcomes (4)
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
Study Arms (1)
Autologous hematopoietic stem cell transplantation combined with CD19-CART
EXPERIMENTALInterventions
Autologous CD19-CAR T cells were transfused +7 days after autologous hematopoietic stem cell transplantation
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NO.288 Nanjing Road，Heping District，Tianjin, Tianjin,
Tianjin, Tianjin Municipality, 300000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2024
First Posted
September 23, 2024
Study Start
June 25, 2024
Primary Completion (Estimated)
May 30, 2026
Study Completion (Estimated)
May 30, 2028
Last Updated
September 23, 2024
Record last verified: 2024-09