EUCTR2016-000297-38-GB
Active, not recruiting
Phase 1
ong-term follow-up study of patients who have previously been exposed to UCART19 / ALLO-501 (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 enrollmentApril 15, 2016
ConditionsAdvanced lymphoid malignanciesMedDRA version: 21.0Level: LLTClassification code 10060390Term: Leukaemia lymphoblastic acuteSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10008958Term: Chronic lymphocytic leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
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
- last year
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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