RecruitingPhase 2NCT06608342

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


Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

20 participants

Start Date

Jun 25, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria4

  • 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 Criteria5

  • 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

Interventions

BIOLOGICALAutologous hematopoietic stem cell transplantation combined with CD19-CART

Autologous CD19-CAR T cells were transfused +7 days after autologous hematopoietic stem cell transplantation


Locations(1)

NO.288 Nanjing Road,Heping District,Tianjin, Tianjin,

Tianjin, Tianjin Municipality, China

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NCT06608342


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