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

Login to your account

Did you forget your password?