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CART-19 Cells For MRD Positive CD19+ ALL (CCFMPCA)

Primary Purpose

Acute Lymphoblastic Leukemia

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

CART-19

About this trial

This is an interventional treatment trial for Acute Lymphoblastic Leukemia

Eligibility Criteria

1 Year - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

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 treated

Outcomes

Primary Outcome Measures

Leukemia free survival

Secondary Outcome Measures

Adverse events that are related to treatment

Full Information

NCT ID

NCT03027739

First Posted

January 17, 2017

Last Updated

January 19, 2017

Sponsor

Fujian Medical University

1. Study Identification

Unique Protocol Identification Number

NCT03027739

Brief Title

CART-19 Cells For MRD Positive CD19+ ALL

Acronym

CCFMPCA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Unknown status

Study Start Date

November 2016 (undefined)

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

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Lymphoblastic Leukemia

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 treated

Intervention Type

Biological

Intervention Name(s)

CART-19

Intervention Description

CART-19 cells treated

Primary Outcome Measure Information:

Title

Leukemia 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

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jianda Hu, Prof.M.D.Ph.D

Phone

86-13959169016

drjiandahu@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jianda Hu, 86-13959169016

Organizational Affiliation

Fujian Medical University Union Hospital

Official's Role

Principal Investigator

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.M.D.Ph.D

Phone

+86-13959169016

drjiandahu@163.com

First Name & Middle Initial & Last Name & Degree

Jianda Hu, Prof.M.D.Ph.D

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

CART-19 Cells For MRD Positive CD19+ ALL

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