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

Institute of Hematology & Blood Diseases Hospital, China1 site in 1 country20 target enrollmentJune 25, 2024

ConditionsAcute Lymphoblastic Leukemia ALL

InterventionsAutologous hematopoietic stem cell transplantation combined with CD19-CART

DrugsAutologous hematopoietic stem cell transplantation combined with CD19-CART

Overview

Phase: Phase 2
Intervention: Autologous hematopoietic stem cell transplantation combined with CD19-CART
Conditions: Acute Lymphoblastic Leukemia ALL
Sponsor: Institute of Hematology & Blood Diseases Hospital, China
Enrollment: 20
Locations: 1
Primary Endpoint: Relapse rate within 2 years
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Detailed Description

Registry

clinicaltrials.gov

Start Date

June 25, 2024

End Date

May 30, 2028

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Responsible Party

Sponsor

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

Arms & Interventions

Autologous hematopoietic stem cell transplantation combined with CD19-CART

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

Outcomes

Primary Outcomes

Relapse rate within 2 years

Time Frame: Time Frame: From autologous hematopoietic stem cell transplantation to 2 years after transplantation

Secondary Outcomes

Overall survival rate(Time Frame: From autologous hematopoietic stem cell transplantation to 2 years after transplantation)
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)
Incidence of infection(Time Frame: From autologous hematopoietic stem cell transplantation to 2 years after transplantation)