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

September 19, 2024 updated by: Institute of Hematology & Blood Diseases Hospital, China

Clinical Study of Autologous Hematopoietic Stem Cell Transplantation Combined With CD19-CART Treatment for 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China, 300000
        • Recruiting
        • NO.288 Nanjing Road，Heping District，Tianjin, Tianjin,
        • Contact:
        • Contact:
          • rongli RL zhang
          • Phone Number: 022-23608602 +86-13194633608
        • Principal Investigator:
          • erlie EL jiang, Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Autologous hematopoietic stem cell transplantation combined with CD19-CART
Biological: Autologous hematopoietic stem cell transplantation combined with CD19-CART
Autologous CD19-CAR T cells were transfused +7 days after autologous hematopoietic stem cell transplantation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Non-relapse mortality
Time Frame: Time Frame: From autologous hematopoietic stem cell transplantation to 2 years after transplantation
Time Frame: From autologous hematopoietic stem cell transplantation to 2 years after transplantation
Progression-free survival
Time Frame: Time Frame: From autologous hematopoietic stem cell transplantation to 2 years after transplantation
Time Frame: From autologous hematopoietic stem cell transplantation to 2 years after transplantation
Overall survival rate
Time Frame: Time Frame: From autologous hematopoietic stem cell transplantation to 2 years after transplantation
Time Frame: From autologous hematopoietic stem cell transplantation to 2 years after transplantation
Incidence of infection
Time Frame: Time Frame: From autologous hematopoietic stem cell transplantation to 2 years after transplantation
Time Frame: From autologous hematopoietic stem cell transplantation to 2 years after transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Collaborators

Juventas Cell Therapy Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 25, 2024

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

May 30, 2028

Study Registration Dates

First Submitted

September 6, 2024

First Submitted That Met QC Criteria

September 19, 2024

First Posted (Actual)

September 23, 2024

Study Record Updates

Last Update Posted (Actual)

September 23, 2024

Last Update Submitted That Met QC Criteria

September 19, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT2024036

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Haven't thought it through yet

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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