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Trial Title:
Autologous Hematopoietic Stem Cell Transplantation Combined With CD19-CART Treatment of Adult High-risk Acute Lymphoblastic Leukemia
NCT ID:
NCT06608342
Condition:
Acute Lymphoblastic Leukemia ALL
Conditions: Official terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Conditions: Keywords:
inaticabtagene autoleucel
auto-HSCT
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Autologous hematopoietic stem cell transplantation combined with CD19-CART
Description:
Autologous CD19-CAR T cells were transfused +7 days after autologous hematopoietic stem
cell transplantation
Arm group label:
Autologous hematopoietic stem cell transplantation combined with CD19-CART
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
NO.288 Nanjing Road，Heping District，Tianjin, Tianjin,
Address:
City:
Tianjin
Zip:
300000
Country:
China
Status:
Recruiting
Contact:
Last name:
erlie EL Jiang, Doctor
Phone:
+86-15122538106
Phone ext:
022-23608602
Email:
jiangerlie@ihcams.ac.cn
Contact backup:
Last name:
rongli RL zhang
Phone:
+86-13194633608
Phone ext:
022-23608602
Investigator:
Last name:
erlie EL jiang, Doctor
Email:
Principal Investigator
Start date:
June 25, 2024
Completion date:
May 30, 2028
Lead sponsor:
Agency:
Institute of Hematology & Blood Diseases Hospital, China
Agency class:
Other
Collaborator:
Agency:
Juventas Cell Therapy Ltd.
Agency class:
Industry
Source:
Institute of Hematology & Blood Diseases Hospital, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06608342
