This study is currently recruiting participants.
Number
000867-CC
Sponsoring Institute
National Institutes of Health Clinical Center (CC)
Recruitment Detail
Type: Participants currently recruited/enrolled Gender: Male & Female Min Age: N/A Max Age: N/A
Referral Letter Required
Yes
Population Exclusion(s)
None
Keywords
AML; Bone Marrow; Reagent; Cd34; Non-Investigational
Recruitment Keyword(s)
Condition(s)
AML
Investigational Drug(s)
Investigational Device(s)
Intervention(s)
Supporting Site
NIH Clinical Center
This protocol enables use of a Humanitarian Use Device (HUD) indicated for processing hematopoietic progenitor cells collected by apheresis (HPC, Apheresis) from an allogeneic, HLA-identical, sibling donor to obtain a CD34+ cell-enriched 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 are non-investigational 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.
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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). EXCLUSION CRITERIA: -Patients with known hypersensitivity to murine (mouse) proteins or iron dextran. -Inability to meet the 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).
EXCLUSION CRITERIA:
-Patients with known hypersensitivity to murine (mouse) proteins or iron dextran.
-Inability to meet the inclusion criteria.
Principal Investigator
Referral Contact
For more information: