CART-19 Cells for R/R B-cell Lymphoma

Relapsed or Refractory B-cell Lymphoma Clinical Trial

— CCFRRBL  

Official title:

CART-19 Cells For Patients With Relapsed or Refractory B-cell Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03391726
• Other study ID #: CART-19-01
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: December 30, 2017
• Last updated: December 30, 2017
• Start date: January 1, 2016
• Est. completion date: December 2020

Study information

• Verified date: December 2017
• Source: Fujian Medical University
• Contact: Jianda Hu, Prof.M.D.Ph.D
• Phone: 86-13959169016
• Email: drjiandahu[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Relapsed/Refractory B Cell Lymphoma is a challenge to be treated, however,CART-19 cells could be very promosing. This study aims to assess the safety and toxicity of CART-19 cells for patients with relapse or refractory B cell lymphoma.

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 65 Years

Eligibility

Inclusion Criteria:

• Signed written informed consent

• Aged between 1-65 years

• Patients with relapse/refractory B-cell lymphoma

• 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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Relapsed or Refractory B-cell Lymphoma

Intervention

Other:
• CART-19 cells
CART-19 cells treat

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	Disease-free survival		1 year
Secondary	Adverse events that are related to treatment		1 year