A Long-term Follow-up Study of Patients Who Received VOR33
- Conditions
- Leukemia, Myeloid, Acute
- Registration Number
- NCT05309733
- Lead Sponsor
- Vor Biopharma
- Brief Summary
VOR33 long-term follow-up (LTFU) study
- Detailed Description
VBP201 study is the VOR33 long-term follow-up (LTFU) study focusing on assessing long term safety and efficacy of VOR33. This study may last up to 15 years (counted from the date of VOR33 infusion completion). All patients who have participated in a study involving the drug product VOR33 and have completed the applicable study or prematurely discontinued, but have at least received the VOR33 infusion, will be asked to participate in the LTFU study.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 10
-
A patient is included in this study if he/she:
- Has received any part of or all of a VOR33 infusion
- There are no exclusion criteria.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Long term safety of VOR33 in patients who participated in a VOR33 study in terms of study product-related Adverse Events/Serious Adverse Events (AEs/SAEs). Years 1-15 Incidence of VOR33-related AEs/SAEs or deaths.
- Secondary Outcome Measures
Name Time Method Long term efficacy of VOR33 in patients who participated in a VOR33 study in terms of persistence of CD33-negative hematopoiesis, overall survival (OS), and monthly relapse free survival (RFS). Years 1-15 Percentage of CD33-negative hematopoiesis and change over time. Overall rates of RFS measured from the time of hematopoietic cell transplantation (HCT) to the date of disease relapse, and OS rates defined as the time from HCT to the date of death from any cause.
Trial Locations
- Locations (11)
University of California San Diego Moores Cancer Center
🇺🇸La Jolla, California, United States
Miami Cancer Institute
🇺🇸Miami, Florida, United States
National Institutes of Health, Clinical Center
🇺🇸Bethesda, Maryland, United States
Washington University School of Medicine Siteman Cancer Center
🇺🇸Saint Louis, Missouri, United States
John Theurer Cancer Center at Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
Columbia University Medical Center - Herbert Irving Comprehensive Cancer Center
🇺🇸New York, New York, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
University Hospitals Seidman Cancer Center
🇺🇸Cleveland, Ohio, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
Scroll for more (1 remaining)University of California San Diego Moores Cancer Center🇺🇸La Jolla, California, United States