Long-Term Follow-up Protocol for Subjects Treated with JCAR015

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-003400-31-BE

Enrollment

105

Registered

2016-11-17

Start date

2016-12-15

Completion date

Unknown

Last updated

2017-08-28

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

Conditions

B-cell Acute Lymphoblastic Leukemia (ALL) MedDRA version: 19.0 Level: LLT Classification code 10000845 Term: Acute lymphoblastic leukemia System Organ Class: 100000004864

Interventions

Product Name: JCAR015 Product Code: JCAR015 Pharmaceutical Form: Suspension for injection INN or Proposed INN: Autologous CD3+ T Cells Expressing CD19 Chimeric Antigen Receptor Current Sponsor code: J

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subjects who received at least one dose of JCAR015 in a previous treatment protocol, and have discontinued, or completed the post-treatment follow-up period in a previous JCAR015 protocol, as applicable Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 105 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Not Applicable.

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluate long-term safety and efficacy following treatment with JCAR015;Secondary Objective: Not applicable;Primary end point(s): Safety: 1. Incidence of new clinical conditions (recorded as Adverse Events) which may be a delayed consequence of prior treatment with JCAR015, 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 • Unexpected illnesses • Hospitalizations, including dates and reasons • Other clinical condition considered biologically related to the prior JCAR015 treatment by the investigator. • Persistence of JCAR015 cells as assessed by Quantitative polymerase chain reaction (qPCR) of JCAR015 vector sequences 2. Incidence of replication-competent retrovirus (RCR) 3. Efficacy: Where applicable: • Date of Relapse • Date of Death;Timepoint(s) of evaluation of this end point: During the first 5 years from the date of the last dose of JCAR015, subjects will have blood samples collected for laboratory evaluations every 6 months. Laboratory evaluations will include: • Analysis of vector sequences • Analysis of RCR In addition, safety assessments will be conducted at least annually. Following the 5-year (Month 60) visit from the date of the last dose of JCAR015, subjects who remain on study due to persistent vector sequence or positive RCR test results will be contacted annually (within 1 month) for assessment of health status. During this time period, subjects who had a positive test for either RCR or vector sequences at a previous visit will continue to have blood samples collected annually until such time as the samples no longer test positive.	—

Measure

Time frame

Main Objective: Evaluate long-term safety and efficacy following treatment with JCAR015;Secondary Objective: Not applicable;Primary end point(s): Safety: 1. Incidence of new clinical conditions (recorded as Adverse Events) which may be a delayed consequence of prior treatment with JCAR015, 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 • Unexpected illnesses • Hospitalizations, including dates and reasons • Other clinical condition considered biologically related to the prior JCAR015 treatment by the investigator. • Persistence of JCAR015 cells as assessed by Quantitative polymerase chain reaction (qPCR) of JCAR015 vector sequences 2. Incidence of replication-competent retrovirus (RCR) 3. Efficacy: Where applicable: • Date of Relapse • Date of Death;Timepoint(s) of evaluation of this end point: During the first 5 years from the date of the last dose of JCAR015, subjects will have blood samples collected for laboratory evaluations every 6 months. Laboratory evaluations will include: • Analysis of vector sequences • Analysis of RCR In addition, safety assessments will be conducted at least annually. Following the 5-year (Month 60) visit from the date of the last dose of JCAR015, subjects who remain on study due to persistent vector sequence or positive RCR test results will be contacted annually (within 1 month) for assessment of health status. During this time period, subjects who had a positive test for either RCR or vector sequences at a previous visit will continue to have blood samples collected annually until such time as the samples no longer test positive.

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Secondary

Measure	Time frame
Secondary end point(s): Not Applicable.;Timepoint(s) of evaluation of this end point: Not Applicable.	—

Countries

Belgium, France, Germany, Italy, Spain, Switzerland, United Kingdom

Contacts

Public ContactClinicalTrialDisclosure

Celgene Corporation

ClinicalTrialDisclosure@celgene.com+1888260 1599

Outcome results

None listed

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