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Mycophenolic Acid

Sirolimus

Administered 3 x 10\^6 iTregs/kg infusion

Administered 3 x 10\^7 iTregs/kg infusion

Administered 3 x 10\^8 iTregs/kg infusion

Administered 10 x 10\^8 iTregs/kg infusion

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.

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).

iTreg

Margaret MacMillan, MD

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.

Inducible Regulatory T Cells (iTregs) in Non-Myeloablative Sibling Donor Peripheral Blood Stem Cell Transplantation

Dose Escalation Study With Extension of Inducible Regulatory T Cells (iTregs) in Adult Patients Undergoing Non-Myeloablative HLA Identical Sibling Donor Peripheral Blood Stem Cell Transplantation

Targeted adverse events and unexpected events not explained by the PBSCT or disease will be collected \[(1-4 hours after the iTreg infusion and before the PBSCT at day 0) and 24 hours and 48 hours after the iTreg infusion (+/- 2 hours)\]

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).

The return of signs and symptoms of a disease after a remission.

Number (count) of patients alive at 1 year after treatment.

Number (count) of patients alive at Day 100.

Masonic Cancer Center, University of Minnesota

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Inducible Regulatory T Cells (iTregs) in Non-Myeloablative Sibling Donor Peripheral Blood Stem Cell Transplantation	NCT01634217	Acute Myelogeno... Acute Lymphocyt... Chronic Myeloge... Non-Hodgkin Lym... Hodgkin Lymphom... Chronic Lymphoc... Multiple Myelom... Myelodysplastic...	iTreg	18 Years - 75 Years	Masonic Cancer Center, University of Minnesota
Inducible Regulatory T Cells (iTregs) in Non-Myeloablative Sibling Donor Peripheral Blood Stem Cell Transplantation	NCT01634217	Acute Myelogeno... Acute Lymphocyt... Chronic Myeloge... Non-Hodgkin Lym... Hodgkin Lymphom... Chronic Lymphoc... Multiple Myelom... Myelodysplastic...	iTreg	18 Years - 75 Years	Masonic Cancer Center, University of Minnesota

Spots Global Cancer Trial Database for itreg

Every month we try and update this database with for itreg cancer trials from around the world to help patients and their families find trials that might be right for them.
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Spots Global Cancer Trial Database for itreg

Every month we try and update this database with for itreg cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for itreg cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.