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: 21.0 Level: LLT Classification code 10025631 Term: Malignant lymphoid neoplasm NOS System Organ Class: 100000004864
Conditions
Interventions
Pharmaceutical Form:
Sponsors
Celgene Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. All adult and pediatric subjects who received at least one 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 Informed Consent Form (ICF) / Informed Assent Form (IAF) prior to any study-related assessments/procedures being conducted. 3. Not applicable as of Protocol Amendment 01: 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 238 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 196
Exclusion criteria
Exclusion criteria: Not Applicable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To assess the risk of delayed adverse events following exposure to 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 lentiviruses - To assess long-term efficacy following treatment with GM T cells - Describe growth and sexual maturity status for subjects who were aged < 18 years at time of GM T-cell treatment GM = gene modified ;Secondary Objective: To monitor for B-cell levels in subjects who received CD19-directed GM T-cell therapy;Primary end point(s): Safety: - Incidence of delayed Adverse Events considered at least possibly related to prior GM T-cell therapy, including: - 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 - New infection - Other new clinical conditions considered related to the prior GM T-cell therapy by the investigator, including an SPM. - Hospitalizations, for events considered related to or possibly related to prior GM T-cell therapy and unexpected illness, rare disorders or events of unknown etiology, including reasons and dates - Persistence of GM T cells - Analysis of vector integration sites - Incidence of replication-competent lentoviruses - Physical growth as assessed by physical examination (pediatric subjects only) - Sexual maturity (pediatric subjects only) Efficacy Where applicable: - Disease Status - Date of Disease Progression - Date of Relapse - Survival Status ;Timepoint(s) of evaluation of this end point: Other endpoints: Up to 15 years from last GM T-cell infusion | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety (subjects who received CD19-directed GM T-cell therapy) - Lymphocyte count (B-cell);Timepoint(s) of evaluation of this end point: Up to 5 years from last GM T-cell infusion and then until B-cell recovery (B-cell = 3% of lymphocytes and within testing laboratory’s reference range of normal) confirmed by 2 consecutive analyses, or up to 15 years, until subject withdrawal of consent, or death, whichever occurs first | — |
Countries
Austria, Belgium, Canada, Finland, France, Germany, Italy, Japan, Netherlands, Norway, Spain, Sweden, Switzerland, United Kingdom, United States
Contacts
Public ContactClinicalTrialDisclosure
Celgene Corporation
Outcome results
None listed