NCT03391739

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2016

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 30, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 5, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

January 5, 2018

Status Verified

December 1, 2017

Enrollment Period

3.9 years

First QC Date

December 30, 2017

Last Update Submit

December 30, 2017

Conditions

Relapsed/Refractory B-cell ALL

Outcome Measures

Primary Outcomes (1)

  • Leukemia free survival

    1 year

Secondary Outcomes (1)

  • Adverse events that are related to treatment

    1 year

Study Arms (1)

Arm 1

EXPERIMENTAL

CART-19 cells treat

Biological: CART-19 cells

Interventions

CART-19 cellsBIOLOGICAL

CART-19 cells treat

Arm 1

Eligibility Criteria

Age1 Year - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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%

You may not qualify if:

  • Pregnant or lactating females.
  • Any co-morbidity precluding the administration of CART-19 cells.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

RECRUITING

MeSH Terms

Conditions

Burkitt Lymphoma

Condition Hierarchy (Ancestors)

Epstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Central Study Contacts

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

CONTACT

86-13959169016drjiandahu@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the department of Hematology

Study Record Dates

First Submitted

December 30, 2017

First Posted

January 5, 2018

Study Start

January 1, 2016

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

January 5, 2018

Record last verified: 2017-12

Locations

CN(1)