Protocol Details
Humanitarian Use Device (HUD) Protocol for Use of Miltenyi CliniMACS CD34 Reagent System in AML
This study is NOT currently recruiting participants.
Summary
Number |
002533-CC |
Sponsoring Institute |
National Institutes of Health Clinical Center (CC) |
Recruitment Detail |
Type: Recruitment has not started
Gender: Male & Female
Min Age: 17 Years
Max Age: 100 Years |
Referral Letter Required |
Yes |
Population Exclusion(s) |
None |
Keywords |
Humanitarian Use Device (HUD) |
Recruitment Keyword(s) |
None |
Condition(s) |
Acute Myeloid Leukemia (AML) |
Investigational Drug(s) |
None |
Investigational Device(s) |
Miltenyi CliniMACS CD34 Reagent System
|
Intervention(s) |
None |
Supporting Site |
National Cancer InstituteNIH Clinical Center |
Study Description:
This protocol enables use of a "Humanitarian Use Device" (HUD) with an approved Humanitarian Device Exemption (HDE) indicated for processing hematopoietic progenitor cells collected by apheresis (HPC, Apheresis) from an allogeneic, HLA-identical, sibling donor to obtain a CD34+ cellenriched population for hematopoietic reconstitution following a myeloablative preparative regimen without the need for additional graft versus host disease (GVHD) prophylaxis in patients with acute myeloid leukemia (AML) in first morphologic complete remission. HUDs with an approved HDE and when used in accordance with the labelling are noninvestigational devices approved for infrequent use based on evidence of safety and probably efficacy, in contrast to medical devices approved under Premarket Approval (PMA) based on evidence of safety and efficacy. IRB oversight is required for Humanitarian Device Exemption (HDE) from traditional marketing under 21 CFR 814.124.
Objectives:
There is no investigational objective. The objective is to provide independent ethics oversight of a lifesaving HUD approved on the basis of limited efficacy.
Endpoints:
There are no endpoints of this regulatory-compliance protocol.
Eligibility
INCLUSION CRITERIA:
In order to be eligible to participate in this study, an individual must be a patient with AML in first morphologic complete remission (<5% blasts in the bone marrow, no detectable abnormal peripheral blasts, and no extramedullary disease) and with an allogenic HLA-identical, sibling donor.
EXCLUSION CRITERIA:
Patients with known hypersensitivity to murine (mouse) proteins or iron dextran.
Inability to meet the inclusion criteria.
Citations:
Not Provided
Contacts: