Clinical trial NCT05309733: A Long-term Follow-up Study of Patients Who Received VOR33
Official title: A Long-term Follow-up Study of Patients Who Received VOR33
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Leukemia, Myeloid, Acute
Keywords: AML
Acute Myeloid Leukemia
CD33
allogeneic
HCT
hematopoietic stem cell transplant
leukemia
Lead sponsor: Vor Biopharma
Sponsor class: INDUSTRY
First posted: 2022-04-04
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who have received any part of or all of a VOR33 genome-edited hematopoietic stem and progenitor cell therapy product.

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.

Eligibility criteria: Inclusion Criteria:

* A patient is included in this study if he/she:

  1. Has received any part of or all of a VOR33 infusion

Exclusion Criteria:

* There are no exclusion criteria.

Primary outcomes:
measure: 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).
timeFrame: Years 1-15
Secondary outcomes:
measure: 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).
timeFrame: Years 1-15
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California San Diego Moores Cancer Center
state: California
city: Miami
country: United States
facility: Miami Cancer Institute
state: Florida
city: Bethesda
country: United States
facility: National Institutes of Health, Clinical Center
state: Maryland
city: Saint Louis
country: United States
facility: Washington University School of Medicine Siteman Cancer Center
state: Missouri
city: Hackensack
country: United States
facility: John Theurer Cancer Center at Hackensack University Medical Center
state: New Jersey
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Columbia University Medical Center - Herbert Irving Comprehensive Cancer Center
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Cleveland
country: United States
facility: University Hospitals Seidman Cancer Center
state: Ohio
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
city: Montréal
country: Canada
facility: Hôpital Maisonneuve-Rosemont
state: Quebec
Study officials:
References: