University of Alabama at Birmingham
Birmingham, Alabama, 35294-3300, United States
Location status: Recruiting
NCT Number: NCT06047886
Patients with graft failure or delayed engraftment may benefit from a hematopoietic stem cell boost or an additional hematopoietic stem cell transplantation procedure. In such settings standard immune suppression strategies are avoided due to their myelosuppressive nature. Therefore those patients are at increased risk of graft versus host disease, and the infusion of a CD34 selected graft would reduce such a risk. The infusion of CD34 selected graft using CliniMACS plus is currently FDA FDA-approved indication for acute myeloid leukemia. However, the use of the Prodigy would streamline the processing, in terms of hands-off procedure, allowing to provision of this product to the patients without strains on the cell therapy lab team. This procedure has been demonstrated safe and effective in several single-center studies and is currently in advanced phase investigation in several studies for malignant and non-malignant conditions.
Interested in participating?
Request Info4 week–75 year
All sexes
Interventional
Phase 1
Birmingham, Alabama, 35294-3300, United States
Location status: Recruiting
Patients eligible to be treated on this status are status post allogeneic hematopoietic stem cell transplantation for a neoplastic hematologic disorder with the need of a CD34 selected stem cell boost for graft failure or low graft function (e.g. marrow cellularity reduced per age and/or dropping donor chimerism with cytopenias and/or platelets or red blood cells transfusion requirement).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
CD34 stem cell isolation and infusion to reduce alloreactive complication of stem cell infusion
Time frame: 6 years
Incidence of severe (grade III-IV) acute GVHD <=25% at 100 days
Time frame: 6 years
Incidence of extensive chronic GVHD <=10% at one year.
Time frame: 6 years
Improvement of donor chimerism by >=15%
Time frame: 6 years
Clinical improvement, defined as an increase of blood counts with transfusion independence if anemia or thrombocytopenia or freedom for infections if reduced leukocytes
Time frame: 6 years
Rate of one-year non-relapse mortality (NRM).
Time frame: 6 years
Rate of one-year relapse
Time frame: 6 years
Rate of one-year overall survival (OS).
Time frame: 6 years
ANC engraftment or increase
Contact information is provided by the study sponsor or research team.
Antonio Di Stasi, M.D.
CONTACT
Chowdury Nazma
CONTACT
University of Alabama at Birmingham
Other
Feasibility Study of CD34 Selection for GVHD Prophylaxis Using the Automated CliniMACS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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