This phase I/II trial studies the side effects and how well haploidentical stem cells selected using Miltenyi CliniMACS CD34 reagent system works in treating participants with high-risk hematologic disorders. Stem cells selected using Miltenyi CliniMACS CD34 reagent system from a half-matched donor, may increase the number of cells given to participants during stem cell transplantation in combination with umbilical cord blood transplantation.
Additional locations may be listed on ClinicalTrials.gov for NCT03093844.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. To determine safety and efficacy of Miltenyi CliniMACS CD34 reagent system to select haploidentical CD34+ cells.
OUTLINE: Participants are assigned to 1 of 4 groups.
GROUP I: Participants with hematologic malignancies receive fludarabine phosphate intravenously (IV) once daily (QD) on days -6 to -2, cyclophosphamide IV QD on day -6, thiotepa IV QD on days -5 to -4, and undergo total body irradiation (TBI) on days -2 to -1. Participants then undergo umbilical cord blood transplant and haploidentical hematopoietic cell transplantation on day 0 with stem cells selected using CliniMACS CD34 reagent system. Participants also receive cyclosporine IV twice daily (BID) or orally (PO) BID starting day -3 for at least 6 months and mycophenolate mofetil PO daily or BID or IV daily stating day 0 to day 30 with taper.
GROUP II: Participants with hematologic malignancies who cannot tolerate high intensity regimen receive fludarabine phosphate IV QD on days -6 to -2, cyclophosphamide IV QD on day -6, and undergo TBI on -1. Participants then undergo umbilical cord blood transplant and haploidentical hematopoietic cell transplantation on day 0 with stem cells selected using CliniMACS CD34 reagent system. Participants also receive cyclosporine IV BID or PO BID starting day -3 for at least 6 months and mycophenolate mofetil PO daily or BID or IV daily stating day 0 to day 30 with taper.
GROUP III (HIGH DOSE TBI): Participants with hematologic malignancies receive fludarabine phosphate IV QD on days -7 to -6, cyclophosphamide IV QD on days -6 and -5, and undergo TBI BID days -3 to -1. Participants then undergo umbilical cord blood transplant and haploidentical hematopoietic cell transplantation on day 0 with stem cells selected using CliniMACS CD34 reagent system. Participants also receive cyclosporine IV BID or PO BID starting day -3 for at least 6 months and mycophenolate mofetil PO daily or BID or IV daily stating day 0 to day 30 with taper.
GROUP IV: Participants with aplastic anemia receive cyclophosphamide IV QD on days -7 and -6, fludarabine phosphate IV QD on days -5 to -1, anti-thymocyte globulin on days -5 to -2, and undergo TBI on day -1. Participants then undergo umbilical cord blood transplant and haploidentical hematopoietic cell transplantation on day 0 with stem cells selected using CliniMACS CD34 reagent system. Participants also receive cyclosporine IV BID or PO BID starting day -3 for at least 6 months and mycophenolate mofetil PO daily or BID or IV daily stating day 0 to day 30 with taper.
After completion of study treatment, participants are followed up at 60 and 100 days.
Lead OrganizationUCHealth University of Colorado Hospital
Principal InvestigatorJonathan A. Gutman
