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NCT Number: NCT06608342

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

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.

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Key information

Conditions

Acute Lymphoblastic Leukemia ALL Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Tianjin, Tianjin Municipality, 300000, China

Location status: Recruiting

Location contact

erlie EL Jiang, Doctor

CONTACT

[email protected]

+86-15122538106 ext. 022-23608602

erlie EL jiang, Doctor

PRINCIPAL_INVESTIGATOR

rongli RL zhang

CONTACT

+86-13194633608 ext. 022-23608602

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Autologous hematopoietic stem cell transplantation combined with CD19-CART

Biological

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

Primary outcomes

  1. Relapse rate within 2 years

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

Secondary outcomes

  1. Non-relapse mortality

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

  2. Progression-free survival

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

  3. Overall survival rate

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

  4. Incidence of infection

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

Study contacts

Contact information is provided by the study sponsor or research team.

erlie EL Jiang

CONTACT

[email protected]

+86-15122538106

Sponsors and collaborators

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China

Other

Collaborators

  • Juventas Cell Therapy Ltd.

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Sep 23, 2024
Registry last updated
Sep 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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