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

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)

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000297-38-BE

Enrollment

200

Registered

2017-07-05

Start date

2017-08-03

Completion date

Unknown

Last updated

2018-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced lymphoid malignancies MedDRA version: 20.0 Level: LLT Classification code 10060390 Term: Leukaemia lymphoblastic acute System Organ Class: 100000004864

Interventions

Product Name: UCART19 Product Code: S68587 Pharmaceutical Form: Infusion INN or Proposed INN: CD19CAR/RQR8+_TCRaß-_T-cells Current Sponsor code: S68587 Other descriptive name: UCART19 Concentration un

Eligibility

Sex/Gender

All

Inclusion 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

Exclusion criteria: No exclusion criteria for this study

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the long-term safety of patients with advanced lymphoid malignancies who have been previously administered with UCART19.;Secondary Objective: - To assess the long-term anti leukemic activity (disease outcome, disease-free survival and overall survival), - To assess the proportion of patients who underwent allogeneic HSCT (Hematopoietic Stem Cell Transplantation), - To assess the time to transplant, - To monitor the long-term persistence of UCART19 in blood, - To monitor the long-term persistence of UCART19 in bone marrow (if a bone marrow aspirate is collected by the centre as part of the routine care of the patient's disease);Primary end point(s): The safety of UCART19 will be assessed throughout the study by evaluation of the following parameters: 1- Number, duration, outcome of all adverse events (AE) 2- Number, duration, outcome of AE of special interest regardless the relationship with UCART19 and any AE assessed as related to UCART19 3- Number of AEs leading to death 4- For paediatric patients: the potential impact on growth curve and puberty will be assessed by height, weight, Tanner staging and menstrual cycle status 5- If an allo-HSCT is performed, engraftment will be assessed through the reporting of haematological data and chimerism status (if data available from the patient’s medical file);Timepoint(s) of evaluation of this end point: 1- within 12 months post last UCART19 infusion 2- throughout the study 3- up to the end of the study 4- Month 3 post last UCART19 infusion, Month 6 and Month 12, then every 6 months up to Year 3, and yearly until Year 15 5- Up to 3 months post allo-HSCT	—

Measure

Time frame

Main Objective: To evaluate the long-term safety of patients with advanced lymphoid malignancies who have been previously administered with UCART19.;Secondary Objective: - To assess the long-term anti leukemic activity (disease outcome, disease-free survival and overall survival), - To assess the proportion of patients who underwent allogeneic HSCT (Hematopoietic Stem Cell Transplantation), - To assess the time to transplant, - To monitor the long-term persistence of UCART19 in blood, - To monitor the long-term persistence of UCART19 in bone marrow (if a bone marrow aspirate is collected by the centre as part of the routine care of the patient's disease);Primary end point(s): The safety of UCART19 will be assessed throughout the study by evaluation of the following parameters: 1- Number, duration, outcome of all adverse events (AE) 2- Number, duration, outcome of AE of special interest regardless the relationship with UCART19 and any AE assessed as related to UCART19 3- Number of AEs leading to death 4- For paediatric patients: the potential impact on growth curve and puberty will be assessed by height, weight, Tanner staging and menstrual cycle status 5- If an allo-HSCT is performed, engraftment will be assessed through the reporting of haematological data and chimerism status (if data available from the patient’s medical file);Timepoint(s) of evaluation of this end point: 1- within 12 months post last UCART19 infusion 2- throughout the study 3- up to the end of the study 4- Month 3 post last UCART19 infusion, Month 6 and Month 12, then every 6 months up to Year 3, and yearly until Year 15 5- Up to 3 months post allo-HSCT

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Secondary

Measure	Time frame
Secondary end point(s): - Proportion of patients who relapse or progress among patients who had not relapsed (progression-free survival, disease specific survival) - Duration of response from the date of first CR or CRi until the date of progression or death due to any cause, whichever occurs first. - Overall survival (OS) - Proportion of patients who underwent allogeneic HSCT and time to transplant;Timepoint(s) of evaluation of this end point: M3 post last UCART19 infusion, M6 and M12, then every 6 months up to year 3, and yearly until year 15	—

Measure

Time frame

Secondary end point(s): - Proportion of patients who relapse or progress among patients who had not relapsed (progression-free survival, disease specific survival) - Duration of response from the date of first CR or CRi until the date of progression or death due to any cause, whichever occurs first. - Overall survival (OS) - Proportion of patients who underwent allogeneic HSCT and time to transplant;Timepoint(s) of evaluation of this end point: M3 post last UCART19 infusion, M6 and M12, then every 6 months up to year 3, and yearly until year 15

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Countries

Belgium, France, United Kingdom, United States

Contacts

Public ContactClinical Studies Department

Institut de Recherches Internationales Servier (I.R.I.S)

clinicaltrials@servier.com+33 155724366

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026