CART-19 Cells For R/R B-ALL

Phase 2

• Conditions: Relapsed/Refractory B-cell ALL

• Registration Number: NCT03391739
• Lead Sponsor: Fujian Medical University

Brief Summary

There are limited treatment options for relapse/refractory B-cell acute lymphoblastic leukemia(ALL). However,CART-19 cells has emerged as a powerful targeted immunotherapy for highly refractory CD19+ acute lymphoblastic leukemia (ALL). This study aims to assess the safety and toxicity of CART-19 cells to patients with relapse/refractory B-cell ALL.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Status Verified: 2017-12
• Study First Submitted: 2017-12-30
• Study First Submitted QC: 2017-12-30
• Last Update Submitted: 2017-12-30
• Study First Posted: 2018-01-05
• Last Update Posted: 2018-01-05
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Signed written informed consent
• Aged between 1-60 years
• Patients with relapsed/refractory B-cell 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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Leukemia free survival	1 year

Secondary Outcome Measures

Name	Time	Method
Adverse events that are related to treatment	1 year

Trial Locations

Locations (1)

Fujian Medical University Union Hospital; 🇨🇳 Fuzhou, Fujian, China