Back to resultsCART-19 Cells for R/R B-cell Lymphoma (CCFRRBL)
Primary Purpose
Relapsed or Refractory B-cell Lymphoma
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
CART-19 cells
Sponsored by
About this trial
This is an interventional treatment trial for Relapsed or Refractory B-cell Lymphoma
Eligibility Criteria
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.
Sites / Locations
- Fujian Medical University Union HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm 1
Arm Description
CART-19 cells treat
Outcomes
Primary Outcome Measures
Disease-free survival
Secondary Outcome Measures
Adverse events that are related to treatment
Full Information
NCT ID
NCT03391726
First Posted
December 30, 2017
Last Updated
December 30, 2017
Sponsor
Fujian Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03391726
Brief Title
CART-19 Cells for R/R B-cell Lymphoma
Acronym
CCFRRBL
Official Title
CART-19 Cells For Patients With Relapsed or Refractory B-cell Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fujian Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed or Refractory B-cell Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Description
CART-19 cells treat
Intervention Type
Other
Intervention Name(s)
CART-19 cells
Intervention Description
CART-19 cells treat
Primary Outcome Measure Information:
Title
Disease-free survival
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Adverse events that are related to treatment
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianda Hu, Prof.M.D.Ph.D
Phone
86-13959169016
Email
drjiandahu@163.com
Facility Information:
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianda Hu, Prof.
Phone
86-13959169016
Email
drjiandahu@163.com
First Name & Middle Initial & Last Name & Degree
Ting Yang, Prof.
Phone
86-13950210357
Email
yang.hopeting@gmail.com
First Name & Middle Initial & Last Name & Degree
Jianda Hu, Prof.
12. IPD Sharing Statement
Learn more about this trial
CART-19 Cells for R/R B-cell Lymphoma
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