ong Term Follow Up Study for Participants of Kite Sponsored Interventional Studies Treated with Gene Modified Cells
Phase 3
- Conditions
- B-cell malignanciessolid or hematological tumors1001884910024324
- Registration Number
- NL-OMON51477
- Lead Sponsor
- Kite Pharma Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
1) The subject must have received an infusion of gene-modified cells in a
completed Kite sponsored parent study, has not withdrawn full consent,
and has discontinued or completed the post-treatment follow-up period
in the parent study, as applicable
2) The subject must understand and voluntarily sign an Informed
Consent Form (ICF) or an Informed Assent Form prior to any studyrelated
assessments or procedures being conducted
3) In the investigator's judgment, the subject is willing and able to
complete the protocol required follow-up schedule and comply with the
study requirements for participation
Exclusion Criteria
There are no specific exclusion criteria for this study.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>• Assess the occurrence of the following late-onset targeted AEs/SAEs suspected<br /><br>to be possibly related to gene modified cells:<br /><br>* Neurologic disorders: type, date of onset, severity, treatment, and date of<br /><br>resolution<br /><br>* Autoimmune disorders: type, date of onset, severity, treatment, and date of<br /><br>resolution<br /><br>* Hematologic disorders: type, date of onset, severity, treatment, and date of<br /><br>resolution<br /><br>* Serious infections (ie, viral, bacterial, or fungal): type, organism, and<br /><br>timing of infection<br /><br>* Secondary malignancies: time to development of the secondary malignancy,<br /><br>type, location, and staging<br /><br>• Mechanism of RCR/RCL and/or insertional mutagenesis<br /><br>• Height, weight, and sexual maturation of pediatric and adolescent subjects</p><br>
- Secondary Outcome Measures
Name Time Method <p>• Subsequent anticancer therapies<br /><br>• Survival status<br /><br>• Cause of death<br /><br>• Evidence of immune reconstitution<br /><br>• Rates of RCR/RCL</p><br>