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Clinical Trials in China / NCT06608342
Recruiting Phase 2

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

NCT06608342 · tracked via the Priya Life Science China tracker
Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Phase
Phase 2
Started
2024-06-25
Last updated
2024-09-23

Condition(s) studied

Acute Lymphoblastic Leukemia ALL

Investigational drug(s) / intervention(s)

Autologous hematopoietic stem cell transplantation combined with CD19-CART

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

Study 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

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Relapse rate within 2 years — Time Frame: From autologous hematopoietic stem cell transplantation to 2 years after transplantation

Trial sites (1)

FacilityCityRegionStatus
NO.288 Nanjing Road，Heping District，Tianjin, Tianjin, Tianjin Tianjin Municipality Recruiting

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Other trials for the same condition

Tracjectories and Predictors of Chemotherapy Induced Peripheral Neuropathy in Children With Acute Lymphoblastic Leukemia Recruiting
Newly-diagnosed Intermediate/High Risk Pediatric B-cell ALL Protocol Recruiting
Newly-diagnosed Low Risk Pediatric B-cell ALL Protocol Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06608342 on ClinicalTrials.gov ↗ ← All trials in China