EUCTR2016-000297-38-BE
Active, not recruiting
Phase 1
ong-term follow-up study of patients who have previously been exposed to UCART19 (allogeneic engineered T-cells expressing a lentiviral-based anti-CD19 chimeric antigen receptor)
Institut de Recherches Internationales Servier (I.R.I.S)0 sites200 target enrollmentJuly 5, 2017
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Advanced lymphoid malignancies
- Sponsor
- Institut de Recherches Internationales Servier (I.R.I.S)
- Enrollment
- 200
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Written informed consent obtained prior any study\-specific procedure (patient or parent(s) or legal representative);
- •\- Patient dosed with UCART19 who completed or discontinued early from a sponsored or from any investigator\-initiated study that tested UCART19, or patients who were administered UCART19 under a special access scheme (compassionate use);
- •\- Female patients of childbearing potential and male patients with partners of childbearing potential must continue to use an effective method of birth control as well as their partners.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 100
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 75
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 25
Exclusion Criteria
- •No exclusion criteria for this study
Outcomes
Primary Outcomes
Not specified
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