This study is currently recruiting participants.
Number
000732-C
Sponsoring Institute
National Cancer Institute (NCI)
Recruitment Detail
Type: Participants currently recruited/enrolled Gender: Male & Female Min Age: 18 Years Max Age: N/A
Referral Letter Required
Yes
Population Exclusion(s)
Children
Keywords
AML; Acute Myeloid Leukemia; Cd33; Allogeneic; HCT; Hematopoietic Stem Cell Transplant; Leukemia; Natural History
Recruitment Keyword(s)
None
Condition(s)
Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Neoplasms by Histologic Type; Neoplasms
Investigational Drug(s)
VOR33
Investigational Device(s)
Intervention(s)
Supporting Site
National Cancer Institute
VOR33 is a product that contains blood stem cells that have been edited to remove a specific protein. VOR33 is being given to people in clinical trials as a potential treatment for certain types of cancer; however, the FDA has not approved this product. This natural history study will monitor people who have received VOR33 in clinical trials to see what effects this product may have on them over the long term.
Objective:
To monitor the long-term safety and efficacy of VOR33.
Eligibility:
People who have received any part or all of a VOR33 treatment in a clinical study.
Design:
Participants will be in this study for up to 15 years. They will have a study visit 1 time each year.
During each visit, participants will have a physical exam. They will have blood tests. They will talk to the study doctor about how they have been feeling. They will talk about changes in their medical history. They will list any new medications they are taking.
If participants develop a new cancer, they will have a bone marrow biopsy. A large needle will be inserted into a small incision in their body; a sample of the soft tissue from inside a large bone will be removed.
The first 5 study visits must be in person. The next 10 visits may be conducted by telephone with the participant or the participant s own health care provider. Participants will have an in-person visit at the end of the study.
--Back to Top--
INCLUSION CRITERIA: Patients are included in this study if they: 1. Have received any part of or all of a VOR33 infusion; 2. Have signed informed consent; and 3. Are able to comply with requirements outlined in this protocol. EXCLUSION CRITERIA: There are no exclusion criteria.
Patients are included in this study if they:
1. Have received any part of or all of a VOR33 infusion;
2. Have signed informed consent; and
3. Are able to comply with requirements outlined in this protocol.
EXCLUSION CRITERIA:
There are no exclusion criteria.
Principal Investigator
Referral Contact
For more information: