CART-19 Cells For MRD Positive CD19+ ALL

NCT ID: NCT03027739

Last Updated: 2017-01-23

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

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2020-12-31

Brief Summary

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CART-19 cells has emerged as a powerful targeted immunotherapy, showing striking responses in highly refractory CD19+ acute lymphoblastic leukemia (ALL). This study aims to assess the safety and toxicity of CART-19 cells to patients who are refractory or at highest risk of relapse as defined by MRD+ status.

Detailed Description

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Conditions

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Acute Lymphoblastic Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

CART-19 cells treated

Group Type EXPERIMENTAL

CART-19

Intervention Type BIOLOGICAL

CART-19 cells treated

Interventions

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CART-19

CART-19 cells treated

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Signed written informed consent
* Aged between 1-60 years
* Patients with MRD positive CD19+ ALL
* Cardiac: Left ventricular ejection fraction ≥ 50%
* Adequate renal and hepatic function
* Performance status: Karnofsky ≥ 70%

Exclusion Criteria

* Pregnant or lactating females.
* Any co-morbidity precluding the administration of CART-19 cells.
Minimum Eligible Age

1 Year

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fujian Medical University

OTHER

Sponsor Role lead

Responsible Party

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Jianda Hu

Director of the department of Hematology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jianda Hu, 86-13959169016

Role: PRINCIPAL_INVESTIGATOR

Fujian Medical University Union Hospital

Locations

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Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jianda Hu, Prof.M.D.Ph.D

Role: CONTACT

86-13959169016

Facility Contacts

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Jianda Hu, Prof.M.D.Ph.D

Role: primary

+86-13959169016

Other Identifiers

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CART-19-02

Identifier Type: -

Identifier Source: org_study_id

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