Clinical Trials Logo

Clinical Trial Summary

This is a single-center Phase I study to determine the maximum tolerated dose and safety of Neihulizumab for the treatment of Minnesota standard-risk aGVHD. Patients undergoing allogeneic transplant with either a myeloablative or non-myeloablative conditioning regimen, and recipients of all donor sources will be enrolled to this trial.


Clinical Trial Description

Eligible patients will receive Neihulizumab weekly, for up to four doses. Responding patients, and patients with stable disease should receive all four weekly doses. Patients with skin only disease that clinically progresses by one stage (e.g, from stage 2 to stage 3), but remains less than stage 4, will receive a minimum two doses of Neihulizumab. At 72 hours after the second dose, non-responding patients will be withdrawn from the study. Responding patients should remain on study and receive four total doses. Patients with lower GI GVHD that progresses by at least one stage at 4 or more days after first dose will be withdrawn from the study. All patients receiving at least 1 dose of Neihulizumab will be evaluated for dose-limiting toxicities (DLTs) and adverse events. Dose-escalation will be conducted according to a 3+3 design. The initial dose of Neihulizumab will be 6 mg/kg weekly (Dose level 1), and the highest dose administered will be 9 mg/kg weekly (Dose level 2). The DLT observation period will be 28 days. Patients will be entered sequentially to each dose level. For each dose level, if none of the first 3 patients at that level experiences a DLT, new patients may be entered at the next higher dose level. If 1 of 3 patients experiences a DLT, up to 3 more patients are to be treated at that same dose level. If none of the additional 3 patients at that dose level experiences a DLT, new patients may be entered at the next higher dose level. However, if 1 or more of the additional 3 patients experience a DLT, then no further patients are to be started at that dose level and the preceding dose is the maximum-tolerated dose (MTD). If 2 of 3 of the initially dosed patients experience a DLT on the first dose level, Neihulizumab will be administered at a lower dose, 3mg/kg weekly (Dose level -1). Finally, if 0 of 3 patients experience DLT at the highest dose level, an additional 3 patients will be enrolled to ensure that 6 patients are treated at the MTD. The MTD will be defined as the highest dose level at which no more than 1 of 6 treated patients, experiences a DLT. Upon determination of MTD, an expansion cohort of 4-7 patients will be enrolled so that a total of 10 patients are enrolled at the potential Phase II dose. This will be done to preliminarily assess efficacy. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04144036
Study type Interventional
Source Medical College of Wisconsin
Contact Medical College of Wisconsin Cancer Center Clinical Trials Offic
Phone 866-680-0505
Email cccto@mcw.edu
Status Recruiting
Phase Phase 1
Start date December 14, 2020
Completion date November 30, 2024

See also
  Status Clinical Trial Phase
Active, not recruiting NCT01428973 - Minitransplants With HLA-matched Donors : Comparison Between 2 GVHD Prophylaxis Regimens Phase 2
Not yet recruiting NCT00749164 - Allogeneic Mesenchymal Stem Cell for Graft-Versus-Host Disease Treatment Phase 1/Phase 2
Completed NCT00993343 - Randomized Trial Comparing Sirolimus and Tacrolimus Versus Cyclosporine and Methotrexate as Graft-versus-host Disease (GVHD) Prophylaxis After Allogeneic Stem Cell Transplantation Phase 3
Completed NCT00360685 - Tacrolimus and Mycophenolate Mofetil (MMF) in GVHD Prophylactic Regimen Compared to Tacrolimus and Methotrexate (MTX N/A
Active, not recruiting NCT04503616 - Cyclophosphamide, Abatacept, and Tacrolimus for GvHD Prevention Phase 1/Phase 2
Terminated NCT02080195 - Nonmyeloablative Conditioning and Transplantation for Patients With Refractory Systemic Lupus Erythematosus (SLE) Phase 1/Phase 2
Completed NCT02193880 - Safety of Post-transplant Alpha-beta Depleted T-cell Infusion Following Haploidentical Stem Cell Transplant (Haplo SCT) N/A
Completed NCT02942173 - CD45RA Depleted T-cell Infusion for Prevention of Infections After TCRab/CD19-depleted Allo-HSCT Phase 2/Phase 3
Completed NCT02145403 - Phase 1/2 Study of Carfilzomib for the Prevention of Relapse and GVHD in Allo-HCT for Hematologic Malignancies Phase 1/Phase 2
Recruiting NCT01941394 - Mesenchymal Stem Cells Infusion for aGVHD Prophylaxis Transplantation Phase 2
Completed NCT00141713 - The Use of Etanercept (Enbrel®) in the Treatment of Acute Graft-Versus-Host Disease Phase 2
Recruiting NCT01991301 - Carfilzomib for the Prevention of Graft Versus Host Disease Phase 1
Completed NCT00408928 - Study on the Safety and Effectiveness of VELCADE® in the Treatment of Graft-Versus-Host Disease Phase 2
Completed NCT01633229 - Bone Marrow Stromal Cell Infusions for Stem Cell Transplant Complications Phase 1
Completed NCT05856058 - To Assess SHR0302 Oral Solutions and Tablets in Healthy Subjects Clinical Studies of Relative Bioavailability Phase 1
Completed NCT02342613 - Adoptive Immunotherapy With Activated Marrow Infiltrating Lymphocytes and Cyclophosphamide Graft-Versus-Host Disease Prophylaxis in Patients With Relapse of Hematologic Malignancies After Allogeneic Hematopoietic Cell Transplantation Phase 1
Recruiting NCT06423131 - Prospective Clinical Trial for Children With TCRαβ Depleted vs Traditional Haplo Identicle HSCT N/A
Completed NCT02144025 - Prevention of Ocular Graft-Versus-Host Disease With Topical Cyclosporine in Recipients of Allogeneic HSCT Phase 2
Completed NCT01369914 - The Natural History of Graft-Versus-Host Disease in the Eyes
Completed NCT00806728 - Study of MEDI-507 in With Steroid-Resistant Acute Graft-Versus-Host Disease Phase 1