Clinical trial NCT02181478: Intra-Osseous Co-Transplant of UCB and hMSC
Official title: Intra-osseous Co-transplant of Cord Blood and Mesenchymal Stromal Cells: A Feasibility Study
Conditions: Acute Lymphoblastic Leukemia
Acute Myelogenous Leukemia
Myelodysplastic Syndromes
Myelofibrosis
Relapsed Non-Hodgkin Lymphoma
Refractory Non-Hodgkin Lymphoma
Hodgkin Lymphoma
Refractory Hodgkin Lymphoma
Relapsed Chronic Lymphocytic Leukemia
Refractory Chronic Lymphocytic Leukemia
Lymphoid Malignancies
Chronic Myelogenous Leukemia
Summary: This clinical trial studies intra-osseous donor umbilical cord blood and mesenchymal stromal cell co-transplant in treating patients with hematologic malignancies. Giving low doses of chemotherapy and total-body irradiation before a co-transplant of donor umbilical cord blood and mesenchymal stromal cells into the bone (intra-osseous) helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil at the time of transplant may stop this from happening.
Interventions:
description: All patients will receive a single IV dose of 50 mg/kg of cyclophosphamide on day -6
name: cyclophosphamide
other_name: CPM
CTX
Cytoxan
Endoxan
Endoxana
type: Drug
description: Given by IV during prep at 40mg/m2 for 5 days
name: fludarabine phosphate
other_name: 2-F-ara-AMP
Beneflur
Fludara
type: Drug
description: Undergo single fraction of reduced intensity conditioning (RIC) regimen of 200 cGy TBI without shielding on day -1
name: total-body irradiation
other_name: TBI
type: Radiation
description: Initiated in patients on the day -5. Cyclosporine will be administered orally or intravenously at 2 mg/kg/dose every 12 hours for 2-hour period. Cyclosporine will continue until day +100
name: cyclosporine
other_name: CYSP
Sandimmune
ciclosporin
cyclosporin
cyclosporin A
type: Drug
description: Given at 1g intravenously or orally twice daily from day -5 to +100, or as clinically indicated.
name: mycophenolate mofetil
other_name: Cellcept
MMF
type: Drug
description: Following RIC, on day T+0, dimethylsulphoxide will be removed from the cord blood cells and given as transplant.
name: umbilical cord blood transplantation
other_name: UCB transplantation
cord blood transplantation
transplantation, umbilical cord blood
type: Procedure
description: The total dosage of hMSC will be 2x10^6cells/kg (+/-20%).
name: mesenchymal stem cell transplantation
other_name: hMSC transplantation
type: Procedure
Study arms:
design_group_description: REDUCED INTENSITY CONDITIONING (RIC):<br/>Flu/Cy/TBI: Patients receive cyclophosphamide IV over 2 hours on day -6 and fludarabine phosphate IV on days -6 to -2 and undergo total-body irradiation on day -1.<br/>Flu/Mel: Patients receive fludarabine daily on days -5 to -2, a single dose of melphalan on day -2, and ATG on day -3 and day-2.<br/>GVHD PROPHYLAXIS: Patients receive cyclosporine PO or IV over 2 hours every 12 hours on beginning on days -5 to 100 with taper beginning on day 100 and mycophenolate mofetil IV or PO BID on days -5 to 100.<br/>TRANSPLANT: Patients undergo a co-transplantation of an intra-osseous umbilical cord blood transplantation and a mesenchymal stem cell transplantation on day 0.
design_group_title: Treatment (intra-osseous UCB with hMSC co-transplant)
design_group_type: Experimental
Sponsor: The Case Comprehensive Cancer Center
Collaborators: National Cancer Institute
Drug name mappings:
name: 环孢素
lang: CN
name: Cyclosporine
lang: EN
name: シクロスポリン
lang: JP
name: 磷酸氟达拉滨
lang: CN
name: Fludarabine Phosphate
lang: EN
name: フルダラビンリン酸エステル
lang: JP
name: 环磷酰胺
lang: CN
name: Cyclophosphamide
lang: EN
name: シクロホスファミド水和物
lang: JP
name: 吗替麦考酚酯
lang: CN
name: Mycophenolate Mofetil
lang: EN
name: ミコフェノール酸 モフェチル
lang: JP