An observational study in T-cell Acute Lymphoblastic Leukemia and T-cell Lymphoblastic Lymphoma, sponsored by Wugen, Inc.. Enrolling by invitation at 5 sites in 2 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2024-11-20.
Sponsored by Wugen, Inc. · Observational
This study will provide long-term follow-up for patients who have received treatment with WU-CART-007 in a previous clinical trial. In this study, patients will be followed for up to 15 years after their last dose of WU-CART-007 for evaluation of delayed adverse events, presence of persisting WU-CART-007 vector sequences, and overall survival and progression-free survival.
This long-term follow-up (LTFU) study is designed to follow patients for up to 15 years after WU-CART-007 infusion to evaluate the persistence of the WU-CART-007 cell clones and to explore any unanticipated genetic consequences secondary to the introduction of genetically modified cells. Long-term toxicity, subsequent anti-cancer therapy, and survival status will be monitored.
Patients will transition to this LTFU study when they meet the criteria for discontinuation from the main study or after completing 24 months of follow-up in the main study. Patients will be contacted every 6 months for the first 5 years following WU-CART-007 administration and then yearly, for up to 10 years, for a total of 15 years of follow-up after prior WU-CART-007 treatment or until death, whichever occurs first.
Patients will be evaluated either at the treating site or by the patient's primary Health Care Provider (HCP). Patients will be required to allow key sponsor contacts to continue to access medical records so that information related to their health condition and initial treatment response may be obtained.
2,061 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 490 are open to participants now.
This study's planned enrollment of 44 is below the median of 120 across 300 observational studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.
Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →Wugen, Inc. is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
The patient population will consist of patients who participated in a previous clinical trial where WU-CART-007 was administered.
Inclusion Criteria: Patients that received WU-CART-007 in the context of any investigational study will be eligible to participate in this long-term follow-up study.
Exclusion Criteria: Not Applicable
Patients who received previous treatment with WU-CART-007
Genetic: Genetic: WU-CART-007
No study drug is administered in this study. Patients who have received WU-CART-007 will be enrolled in this study for Long Term Safety and Efficacy
Delayed adverse events (AEs)/serious adverse events (SAEs)
assess the risk of delayed adverse events including serious events following exposure to WU-CART-007
Time frame: up to 15 years
Persistence of WU-CART-007 cells
Peripheral blood samples will be monitored used polymerase chain reaction for persistence of WU-CART-007 cells
Time frame: Every 6 months for up to 5 years and then yearly for up to 15 years
Tanner Staging
Tanner Staging will be used to evaluate growth and development outcomes and sexual maturity status for patients who were \< 18 years of age at the time of treatment with WU CART-007
Time frame: up to 15 years
Overall survival (OS)
To evaluate survival n patients previously treated with WU-CART-007
Time frame: up to 15 years
Progression-free survival (PFS)
To evaluate profession free survival in patients previously treated with WU-CART-007
Time frame: up to 15 years
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Wugen, Inc.