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Autologous Hematopoietic Stem Cell Transplantation Combined With CD19-CART Treatment of Adult High-risk Acute Lymphoblastic Leukemia

I

Institute of Hematology & Blood Diseases Hospital, China

Status and phase

Enrolling
Phase 2

Conditions

Acute Lymphoblastic Leukemia ALL

Treatments

Biological: Autologous hematopoietic stem cell transplantation combined with CD19-CART

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT06608342
IIT2024036

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Autologous hematopoietic stem cell transplantation combined with CD19-CART
Experimental group
Treatment:
Biological: Autologous hematopoietic stem cell transplantation combined with CD19-CART

Trial contacts and locations

1

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Central trial contact

erlie EL Jiang

Data sourced from clinicaltrials.gov

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