CClinicalTrials.gg
Status unknownNCT03027739CCFMPCAUpdated Jan 23, 2017

CART-19 Cells For MRD Positive CD19+ ALL

A Phase 2/3 interventional study of CART-19 in Acute Lymphoblastic Leukemia, sponsored by Fujian Medical University. Status unknown at 1 site in China. Open to participants aged 1 Year to 60 Years. Per ClinicalTrials.gov, last updated 2017-01-23.

Sponsored by Fujian Medical University · Phase 2/3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2/3
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
1 Year to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's planned enrollment of 20 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Fujian Medical University is the lead sponsor of 144 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Pregnant or lactating females.
  • Any co-morbidity precluding the administration of CART-19 cells.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Arm 1

    CART-19 cells treated

    Biological: CART-19

Interventions

  • BiologicalCART-19

    CART-19 cells treated

06

What researchers measure

Primary outcomes

  1. Leukemia free survival

    Time frame: 1 year

Secondary outcomes

  1. Adverse events that are related to treatment

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • Fujian Medical University Union Hospital
    Fuzhou, Fujian 350001, China
    • Jianda Hu, Prof.M.D.Ph.D · Contact · drjiandahu@163.com · +86-13959169016
    • Jianda Hu, Prof.M.D.Ph.D · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03027739
Lead sponsor
Fujian Medical University
Responsible party
Jianda Hu (Director of the department of Hematology, Fujian Medical University) — Principal investigator
First posted
Jan 23, 2017
Start date
Nov 2016
Primary completion
Dec 2019 (estimated)
Completion
Dec 2020 (estimated)
Last update
Jan 23, 2017

Study contacts

Jianda Hu, Prof.M.D.Ph.D
Contact
drjiandahu@163.com
86-13959169016
Jianda Hu, 86-13959169016
principal investigator · Fujian Medical University Union Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion