A Phase 1 interventional study of iTreg in Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia and Chronic Myelogenous Leukemia, sponsored by Masonic Cancer Center, University of Minnesota. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-01-18.
Sponsored by Masonic Cancer Center, University of Minnesota · Phase 1, Interventional, and Treatment
This is a phase I single center dose escalation study with an extension at the best available dose to determine the tolerability of inducible regulatory T cells (iTregs) when given to adult patients undergoing non-myeloablative HLA-identical sibling donor peripheral blood stem cell (PBSC) transplantation for the treatment of a high risk malignancy. Up to 5 dose cohorts will be tested. Once the tolerable dose is determined for iTregs, enrollment will continue with an additional 10 patients using sirolimus/Mycophenolate mofetil (MMF) graft-versus-host disease (GVHD) prophylaxis to gain further safety information and to provide pilot data in this treatment setting.
Co-enrollment in University Of Minnesota protocol MT2001-10 is required and transplantation will be according to that protocol with iTregs administered the morning of day 0 followed no sooner than 4 hours later by the PBSC transplantation.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 16 is below the median of 40 across 4,509 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Masonic Cancer Center, University of Minnesota is the lead sponsor of 284 studies on the registry; 34 are open to participants now.
Of its 39 completed or terminated interventional studies of FDA-regulated products, 28 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
One of the following disease categories:
Adequate organ function within 28 days of study enrollment defined as:
Exclusion Criteria:
Administered 3 x 10\^6 iTregs/kg infusion
Biological: iTreg
Administered 3 x 10\^7 iTregs/kg infusion
Biological: iTreg
Administered 3 x 10\^8 iTregs/kg infusion
Biological: iTreg
Administered 10 x 10\^8 iTregs/kg infusion
Biological: iTreg
Administered 10 x 10\^8 iTregs/kg or best available dose using sirolimus/MMF as graft-versus-host disease (GVHD) prophylaxis. Immunosuppression will consist of a combination of sirolimus and mycophenolate mofetil (MMF). Sirolimus will be administered starting at day -3 with 8mg-12mg oral loading dose followed by single dose 4 mg/day. MMF will be administered starting on day -3 at a dose of 3 gram/day divided in 2 or 3 doses. Intravenous (IV) route between days -3 and +5, then may change to PO between days +6 and +30. Stop MMF at day +30 or 7 days after engraftment, whichever day is later, if no acute GVHD.
Biological: iTreg
The iTregs will be infused at the assigned dose without a filter or pump slowly by gravity over 15-60 minutes. The iTregs should be given at least 4 hours before the peripheral blood stem cell (PBSC) infusion (MT2001-10).
Incidence of grade 3-5 infusional toxicity
Targeted adverse events and unexpected events not explained by the PBSCT or disease will be collected \[(1-4 hours after the iTreg infusion and before the PBSCT at day 0) and 24 hours and 48 hours after the iTreg infusion (+/- 2 hours)\]
Time frame: Within 48 Hours After iTregs Administration
Cumulative incidence of grade II-IV acute graft-versus-host disease (GVHD)
Graft-versus-host disease (GVHD) is a complication that can occur after a stem cell or bone marrow transplant in which the newly transplanted material attacks the transplant recipient's body. Abstracted from the routine clinical data collected for the primary transplant protocol (MT2001-10).
Time frame: Day 100
Incidence of chronic graft-versus-host disease (GVHD)
Graft-versus-host disease (GVHD) is a complication that can occur after a stem cell or bone marrow transplant in which the newly transplanted material attacks the transplant recipient's body. Abstracted from the routine clinical data collected for the primary transplant protocol (MT2001-10).
Time frame: 12 Months
Relapse of Disease
The return of signs and symptoms of a disease after a remission.
Time frame: 12 Months
Survival
Number (count) of patients alive at 1 year after treatment.
Time frame: 1 Year
Survival
Number (count) of patients alive at Day 100.
Time frame: Day 100
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Masonic Cancer Center, University of Minnesota