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NCT03027739 Clinical Trial

CART-19 Cells For MRD Positive CD19+ ALL

Acute Lymphoblastic Leukemia Clinical Trial

— CCFMPCA  

Official title:
CART-19 Cells For Patients With Minimal Residual Disease (MRD) Positive CD19+ Acute Lymphoblastic Leukemia

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03027739
Other study ID # CART-19-02
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received January 17, 2017
Last updated January 19, 2017
Start date November 2016
Est. completion date December 2020

Study information
Verified date January 2017
Source Fujian Medical University
Contact Jianda Hu, Prof.M.D.Ph.D
Phone 86-13959169016
Email drjiandahu@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date December 2020
Est. primary completion date December 2019
Accepts healthy volunteers No
Gender All
Age group 1 Year to 60 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• CART-19
CART-19 cells treated

Locations
Country Name City State
China Fujian Medical University Union Hospital Fuzhou Fujian

Sponsors (1)
Lead Sponsor Collaborator
Fujian Medical University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Leukemia free survival 1 year
Secondary Adverse events that are related to treatment 1 year
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