To hear about similar clinical trials, please enter your email below
Trial Title:
A Long-Term Safety Follow-Up Study for Patients Treat With WU-CART-007
NCT ID:
NCT05509855
Condition:
T-cell Acute Lymphoblastic Leukemia
T-cell Lymphoblastic Lymphoma
Conditions: Official terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Conditions: Keywords:
T-ALL
T-LBL
Study type:
Observational
Overall status:
Enrolling by invitation
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Genetic
Intervention name:
Genetic: WU-CART-007
Description:
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
Arm group label:
Patients treated with WU-CART-007
Summary:
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.
Detailed description:
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.
Criteria for eligibility:
Study pop:
The patient population will consist of patients who participated in a previous clinical
trial where WU-CART-007 was administered.
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
12 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
City of Hope
Address:
City:
Duarte
Zip:
91010
Country:
United States
Facility:
Name:
Childrens Hospital LA
Address:
City:
Los Angeles
Zip:
90027
Country:
United States
Facility:
Name:
Washington University
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Facility:
Name:
Children's Hospital of Philadelphia
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Facility:
Name:
Peter MacCullam Cancer Center
Address:
City:
Melbourne
Country:
Australia
Start date:
August 22, 2022
Completion date:
July 1, 2037
Lead sponsor:
Agency:
Wugen, Inc.
Agency class:
Industry
Source:
Wugen, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05509855