CART-19 Cells For R/R B-ALL | NCT03391739

Studies
CART-19 Cells For R/R B-ALL

NCT03391739

Sponsor

Fujian Medical University

Status

Unknown status

Last Update Posted

Jan 5, 2018Actual

Enrollment

Phase

Phase 2Phase 3

Conditions

Relapsed/Refractory B-cell ALL

Interventions

CART-19 cells

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2016Actual

Primary Completion Date

Dec 2019Estimated

Completion Date

Dec 2019Estimated

First Submitted Date

Dec 30, 2017

First Submission Date that Met QC Criteria

Dec 30, 2017

First Posted Date

Jan 5, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 30, 2017

Last Update Posted Date

Jan 5, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jianda Hu, Director of the department of Hematology, Fujian Medical UniversityPrincipal Investigator

Lead Sponsor

Fujian Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Experimental	CART-19 cells treat	Biological: CART-19 cells

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CART-19 cells	Biological	CART-19 cells treat	Arm 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Leukemia free survival		1 year

Secondary Outcomes

Measure	Description	Time Frame
Adverse events that are related to treatment		1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

60 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jianda Hu, Prof.M.D.Ph.D	Contact	86-13959169016		drjiandahu@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fujian Medical University Union Hospital	Recruiting	Fuzhou	Fujian	350001	China

Condition Browse Module

MeSH Terms

ID	Term
D002051	Burkitt Lymphoma

Ancestor Terms

ID	Term
D020031	Epstein-Barr Virus Infections
D006566	Herpesviridae Infections
D004266	DNA Virus Infections
D014777	Virus Diseases

Browse Leaves

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Browse Branches

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