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EUCTR2017-001465-24

Long-Term Follow-up Protocol for Subjects Treated with Gene-Modified T cells.

Data source: WHO (Imported from 22.11.2020)
Changed: 22.11.2020
Disease category:

Health conditions (Data source: WHO)

Defined by parent protocol. The study will enroll all adult and paediatric subjects who received at least one genetically modified T cells infusion in a previous Celgene sponsored study.
MedDRA version: 21.0Level: LLTClassification code 10025631Term: Malignant lymphoid neoplasm NOSSystem Organ Class: 100000004864;Therapeutic area: Diseases [C] - Cancer [C04]

Interventions (Data source: WHO)


Product Name: Gene-Modified T cells
Product Code: JCAR017, bb2121
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Gene-Modified T cells
Other descriptive name: Gene-Modified T cells
Concentration unit: Other
Concentration type: equal
Concentration number: 0-

Inclusion/Exclusion Criteria (Data source: WHO)

Inclusion criteria:
1. All adult and pediatric subjects who received at least one gene-modified (GM) T cell infusion in a previous Celgene sponsored or Celgene alliance partner sponsored study, and have discontinued, or completed the post-treatment follow-up period in the parent treatment protocol, as applicable.
2. Subject (and, parental/legal representative, when applicable) must understand and voluntarily sign an ICF/IAF prior to any study-related assessments/procedures being
conducted.
3. Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
Are the trial subjects under 18? yes
Number of subjects for this age range: 91
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 222
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 180

Exclusion criteria:
Not Applicable.

Further information on the trial in WHO primary registry

https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-001465-24

Further information on the trial from WHO database (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=EUCTR2017-001465-24-GB

Further information on trial

Date trial registered

17.06.2019

Incorporation of the first participant

24.02.2019

Recruitment status

Authorised-recruitment may be ongoing or finished

Academic title (Data source: WHO)

Long-Term Follow-up Protocol for Subjects Treated with Gene-Modified T cells.

Type of trial (Data source: WHO)

Interventional clinical trial of medicinal product

Design of the trial (Data source: WHO)

Controlled: noRandomised: noOpen: noSingle blind: noDouble blind: noParallel group: noCross over: noOther: yesOther trial design description: Long-Term Follow-up ProtocolIf controlled, specify comparator, Other Medicinial Product: Placebo: Other: Number of treatment arms in the trial: 0

Phase (Data source: WHO)

Human pharmacology (Phase I): noTherapeutic exploratory (Phase II): yesTherapeutic confirmatory - (Phase III): noTherapeutic use (Phase IV): no

Primary end point (Data source: WHO)

Secondary Objective: None;Main Objective: - To assess the risk of delayed adverse events (AEs) following exposure to gene-modified (GM) T cells
- To monitor for long-term persistence of GM T cells, including analysis of vector integration sites, as appropriate.
- To monitor for generation of replication competent retroviruses (RCR)
- To assess long-term efficacy following treatment with GM T cells
- Describe growth, developmental outcome, and sexual maturity status for subjects who were aged < 18 years at time of GM T cell treatment
- To assess long term health-related quality of life following treatment with GM T cells;Primary end point(s): Safety:
- Incidence of delayed Adverse Events suspected to be related to prior gene-modified (GM) T cell therapy, including:
- New malignancies (hematologic or solid)
- New neurologic disorder, or exacerbation of a pre-existing neurologic disorder
- New rheumatologic or autoimmune disorder, or exacerbation of a prior rheumatologic or other autoimmune disorder
- New hematologic disorder
- Other new clinical conditions considered related to the prior GM T cell therapy by the investigator.
Hospitalizations, regardless of relationship to prior treatment, including reasons and dates

- Persistence of GM T cells
- Analysis of vector integration sites
- Incidence of replication-competent retroviruses (RCR)
- Height, weight, growth, and organ development will be assessed for all pediatric subjects
- Sexual maturity status for pediatric subjects

Efficacy
Where applicable:
- Tumor Response Status
- Date of Disease Progression
- Date of Relapse
- Survival Status

HRQoL
Measurement of health-related quality of life (HRQoL) changes as assessed using instruments administered in the parent treatment protocol;Timepoint(s) of evaluation of this end point: HRQoL: Up to 5 years from last GM T cells infusion
Other endpoints: Up to 15 years from last GM T cells infusion

Secundary end point (Data source: WHO)

Secondary end point(s): Not Applicable.;Timepoint(s) of evaluation of this end point: Not Applicable.

Contact information (Data source: WHO)

Celgene Corporation

Trial results (Data source: WHO)

Results summary

Long-Term Follow-up Protocol for Subjects Treated with Gene-Modified T cells.

Link to the results in the primary register

no information available yet

Information on the availability of individual participant data

no information available yet

Trial sites

Countries (Data source: WHO)

Austria, Belgium, Canada, Finland, France, Germany, Italy, Japan, Netherlands, Norway, Spain, Sweden, Switzerland, United Kingdom, United States

Contact for further information on the trial

Contact for general information (Data source: WHO)

ClinicalTrialDisclosure
86 Morris Avenue
Celgene Corporation
+1913 709 6862
ClinicalTrialDisclosure@celgene.com

Contact for scientific information (Data source: WHO)

ClinicalTrialDisclosure
86 Morris Avenue
Celgene Corporation
+1913 709 6862
ClinicalTrialDisclosure@celgene.com

Principal Sponsor/Investigator

Principal sponsor (Data source: WHO)

Celgene Corporation

Further trial identification numbers

Secondary ID (Data source: WHO)

GC-LTFU-001
2017-001465-24-BE