Trials / Completed
CompletedNCT01634217
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- Masonic Cancer Center, University of Minnesota · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
- Acute Myelogenous Leukemia
- Acute Lymphocytic Leukemia
- Chronic Myelogenous Leukemia
- Non-Hodgkin Lymphoma
- Hodgkin Lymphoma
- Chronic Lymphocytic Leukemia
- Multiple Myeloma
- Myelodysplastic Syndrome
Interventions
| Type | Name | Description |
|---|---|---|
| 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). |
Timeline
- Start date
- 2013-11-08
- Primary completion
- 2017-12-01
- Completion
- 2018-12-01
- First posted
- 2012-07-06
- Last updated
- 2019-01-18
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01634217. Inclusion in this directory is not an endorsement.