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

NCT ID: NCT06608342

Last Updated: 2024-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-25

Study Completion Date

2028-05-30

Brief Summary

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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

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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.

Conditions

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Acute Lymphoblastic Leukemia ALL

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Autologous hematopoietic stem cell transplantation combined with CD19-CART

Group Type EXPERIMENTAL

Autologous hematopoietic stem cell transplantation combined with CD19-CART

Intervention Type BIOLOGICAL

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

Interventions

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Autologous hematopoietic stem cell transplantation combined with CD19-CART

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Juventas Cell Therapy Ltd.

INDUSTRY

Sponsor Role collaborator

Institute of Hematology & Blood Diseases Hospital, China

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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erlie EL Jiang

Role: CONTACT

+86-15122538106

Facility Contacts

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erlie EL Jiang, Doctor

Role: primary

+86-15122538106 ext. 022-23608602

rongli RL zhang

Role: backup

+86-13194633608 ext. 022-23608602

Other Identifiers

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IIT2024036

Identifier Type: -

Identifier Source: org_study_id

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