NCT02181478

Intra-Osseous Co-Transplant of UCB and hMSC

Intra-osseous Co-transplant of Cord Blood and Mesenchymal Stromal Cells: A Feasibility Study

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. To estimate the feasibility of combining intra-osseous umbilical cord blood (UCB) hematopoietic stem cells and human mesenchymal stromal cells (hMSC) following reduced intensity conditioning (RIC). SECONDARY OBJECTIVES: I. To estimate the time to engraftment of intra-osseous (IO) UCB transplant combined with hMSC following RIC. II. To estimate the safety profile of IO UBC transplant combined with hMSC. OUTLINE: REDUCED INTENSITY CONDITIONING: Patients receive cyclophosphamide intravenously (IV) over 2 hours on day -6 and fludarabine phosphate IV on days -6 to -2 and undergo total body irradiation (TBI) on day -1. GRAFT-VERSUS-HOST DISEASE (GVHD) PROPHYLAXIS: Patients receive cyclosporine orally (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 twice daily (BID) on days -5 to 100. TRANSPLANT: Patients undergo intra-osseous UCB and hMSC co-transplant on day 0. After completion of study treatment, patients are followed up at days 28 and 100, and then at 6, 9, and 12 months.

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

Interventions

Type	Name	Description
DRUG	cyclophosphamide	All patients will receive a single IV dose of 50 mg/kg of cyclophosphamide on day -6
DRUG	fludarabine phosphate	Given by IV during prep at 40mg/m2 for 5 days
RADIATION	total-body irradiation	Undergo single fraction of reduced intensity conditioning (RIC) regimen of 200 cGy TBI without shielding on day -1
DRUG	cyclosporine	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
DRUG	mycophenolate mofetil	Given at 1g intravenously or orally twice daily from day -5 to +100, or as clinically indicated.
PROCEDURE	umbilical cord blood transplantation	Following RIC, on day T+0, dimethylsulphoxide will be removed from the cord blood cells and given as transplant.
PROCEDURE	mesenchymal stem cell transplantation	The total dosage of hMSC will be 2x10\^6cells/kg (+/-20%).

Timeline

• Start date: 2015-07-22
• Primary completion: 2019-12-19
• Completion: 2020-02-07
• First posted: 2014-07-04
• Last updated: 2020-12-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study