This phase I trial tests the effect of CD34 positive stem cell selection using the automated CliniMACS Prodigy Device in preventing graft-versus-host disease (GVHD) after stem cell transplant in patients with blood cancers. Patients receiving an allogeneic (donor) transplant may experience graft rejection, delayed recovery of the immune system, and GVHD. GVHD is a condition that occurs when donated stem cells or bone marrow (the graft) see the healthy tissues in the body (the host) as foreign and attack them. GVHD can cause damage to the host’s tissues and organs, especially the skin, liver, intestines, eyes, mouth, hair, nails, joints, muscles, lungs, kidneys, and genitals. These signs and symptoms may be severe and life threatening. GVHD disease can occur within the first few months after transplant (acute) or much later (chronic). Using only the type of cells (called CD34+ cells) that will generate new bone marrow and blood cells may help decrease the risk of developing GVHD. To do this, the CD34+ cells for transplant will be selected by a special type of stem cell processing using the CliniMACS Prodigy device. Giving CD34 positive stem cells selected using the CliniMACS Prodigy device may prevent or reduce the severity of GVHD in patients undergoing a stem cell transplant for blood cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT06047886.
Locations matching your search criteria
United States
Alabama
Birmingham
University of Alabama at Birmingham Cancer CenterStatus: Active
Contact: Antonio Di Stasi
Phone: 205-834-4737
PRIMARY OBJECTIVES:
I. Incidence of severe (grade III-IV) acute GVHD at 100 days.
II. Incidence of extensive chronic GVHD at one year.
III. Improvement of donor chimerism by clinical improvement.
SECONDARY OBJECTIVES:
I. Rate of one-year non-relapse mortality (NRM).
II. Rate of one-year relapse.
III. Rate of one-year overall survival (OS).
IV. Absolute neutrophil count (ANC) engraftment or increase.
OUTLINE:
DONOR: Patients undergo peripheral blood stem cell collection per institutional standard of care.
PATIENTS: Patients receive allogeneic CD34-positive enriched peripheral blood stem cells (CD34+ stem cell) infusion on day 0. Patients may also receive conditioning therapy with fludarabine intravenously (IV) on days -4 to -2 and/or total body irradiation for 1 dose with or without cyclophosphamide once daily (QD) for 2 days prior to CD34+ stem cell infusion per clinician discretion. Additionally, patients undergo echocardiography, multigated acquisition scan (MUGA), chest x-ray, and computed tomography (CT) scan pre-transplant and blood sample collection throughout the study.
After completion of study intervention, patients are followed every 2 weeks until day 100 after stem cell infusion then every 30 days for up to 1 year post infusion.
Trial PhaseNo phase specified
Trial Typeprevention
Lead OrganizationUniversity of Alabama at Birmingham Cancer Center
Principal InvestigatorAntonio Di Stasi