A study to evaluate the long-term safety of patients with advanced lymphoid malignancies who have been previously administered with UCART19

Phase 1

• Conditions: Advanced lymphoid malignancies; MedDRA version: 20.0 Level: LLT Classification code 10060390 Term: Leukaemia lymphoblastic acute System Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-000297-38-ES
• Lead Sponsor: Institut de Recherches Internationales Servier (I.R.I.S)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-25
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 200

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified