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Home » Find Clinical Trials » A Study to Evaluate the Long-term Safety of Patients With Advanced Lymphoid Leukemia Who Have Been Previously Administered With UCART19

A Study to Evaluate the Long-term Safety of Patients With Advanced Lymphoid Leukemia Who Have Been Previously Administered With UCART19

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Servier Protocol Code: CL1-68587-003 Sponsor: Institut de Recherches Internationales Servier Clinicaltrials.gov Identifier: NCT02735083 EudraCT Number: 2016-000297-38

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How to participate in this study
If you think you are eligible for this study (see
eligibility criteria
below), you can identify the location closest to you and contact them directly. If you can’t find a location close to you, please contact Institut de Recherches Internationales Servier (I.R.I.S.)
Name: Institut de Recherches Internationales Servier, Département des études cliniques
Phone number: +33 1 55 72 60 00
The study has 16 locations

Study description

The study is needed to test a drug called S068587 (also known as UCART19) over a long period of time in patients with a type of advanced blood cancer called lymphoid leukemia. Lymphoid leukemia is a cancer that affects lymphocytes, a type of white blood cell that protects body by fighting infections. This is a follow-up study to see how safe S068587 is in participants who have previously received S068587 to treat their disease.

B cells are a type of white blood cell that produce proteins to fight foreign substances. In some types of blood cancer, such as lymphoid leukemia, these B cells does not function normally and become cancer cells. S068587 works by killing these cancerous B cells.

The main goal of the study is to see how safe S068587 is when given for long period in participants with advanced lymphoid leukemia.

Official title: Long-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)
Conditions
Advanced Lymphoid Leukemia
Interventions / Treatments
  • UCART19 follow-up
Other study id numbers
  • CL1-68587-003

Eligibility Criteria

Eligible age for the study

(Child, Adult, Older Adult)

Sex

Male/Female

Accepts Healthy Volunteers

No

To take part in the study, participants have to:

  • Have previously been treated with S068587.

This study does not have any exclusion criteria.

How is the study designed?

Allocation
N/A
Interventional study model
Single Group
Participant Group / Arm
Experimental: UCART19 follow-up
Intervention / Treatment
Biological: UCART19 follow-up

UCART19 will not be given during this study. Patients who join this long-term follow-up study have already received UCART19 in a previous study. They can join this follow-up study either at the end of the previous study or at any time after they have received UCART19 if they had to stop the previous study early.