Ongoing studies in AML manipulating Tregs
| NCI study . | Phase . | Center . | Primary question(s) asked . | Status of activity . |
|---|---|---|---|---|
| NCT00539695 | 2 | Baylor College of Medicine | Whether IL-2 increases Tregs as a measure of GVHD prophylaxis | Recruiting |
| NCT00675831 | 1 | Dana-Farber Cancer Institute | Feasibility and safety of CD25+ Treg-depleted DLI in patients with relapsed hematologic malignancies | Recruiting |
| NCT00602693 | 1 | University of Minnesota | MTD of UCB-derived Tregs | Suspended |
| Whether Tregs decrease GVHD | ||||
| NCT00725062 | 1/2 | University of Minnesota | What is MTD of Tregs after sibling alloHCT Whether Tregs decrease GVHD | Closed |
| NCT00987987 | 1/2 | Hôpitaux de Paris | Whether Tregs depletion before DLI improves GVT effect | Completed |
| NCT01050764 | Feasibility | Stanford University | Whether Tregs decrease GVHD after haploidentical alloHCT | Recruiting |
| NCT01096602 | 2 | Beth Israel Deaconess Medical Center | Toxicity and effect of blockade of PD-1 in conjunction with the dendritic cell/AML vaccine in AML patients in CR1 | Recruiting |
| NCT01106950 | 2 | University of Minnesota | Whether Tregs depletion with denileukin diftitox improves outcome before haploidentical NK cells infusion in relapsed/refractory AML patients | Recruiting |
| NCT01163201 | 1/2 | University of Minnesota | Determine the optimal cell dose mixture of UCB T regulatory and CD3+ T effector cells in double UCB transplantation | Not open yet |
| NCT00224354 | 1 | Baylor College of Medicine | Safety and efficacy of deleting Tregs with IL-2 immunotoxin directed to the CD25 antigen and administration of autologous gene-modified tumor cells in patients with CLL | Completed |
| NCT01067287 | 2 | Dana-Farber Cancer Institute | Safety and efficacy of the blockage of PD-1 in conjunction with the dendritic Cell/myeloma vaccines after autoHCT | Recruiting |
| NCT01251952 | 1 | Barbara Ann Karmanos Cancer Institute | Feasibility and safety of giving 2 doses of denileukin diftitox in patients with MM early after autoHCT | Recruiting |
| NCI study . | Phase . | Center . | Primary question(s) asked . | Status of activity . |
|---|---|---|---|---|
| NCT00539695 | 2 | Baylor College of Medicine | Whether IL-2 increases Tregs as a measure of GVHD prophylaxis | Recruiting |
| NCT00675831 | 1 | Dana-Farber Cancer Institute | Feasibility and safety of CD25+ Treg-depleted DLI in patients with relapsed hematologic malignancies | Recruiting |
| NCT00602693 | 1 | University of Minnesota | MTD of UCB-derived Tregs | Suspended |
| Whether Tregs decrease GVHD | ||||
| NCT00725062 | 1/2 | University of Minnesota | What is MTD of Tregs after sibling alloHCT Whether Tregs decrease GVHD | Closed |
| NCT00987987 | 1/2 | Hôpitaux de Paris | Whether Tregs depletion before DLI improves GVT effect | Completed |
| NCT01050764 | Feasibility | Stanford University | Whether Tregs decrease GVHD after haploidentical alloHCT | Recruiting |
| NCT01096602 | 2 | Beth Israel Deaconess Medical Center | Toxicity and effect of blockade of PD-1 in conjunction with the dendritic cell/AML vaccine in AML patients in CR1 | Recruiting |
| NCT01106950 | 2 | University of Minnesota | Whether Tregs depletion with denileukin diftitox improves outcome before haploidentical NK cells infusion in relapsed/refractory AML patients | Recruiting |
| NCT01163201 | 1/2 | University of Minnesota | Determine the optimal cell dose mixture of UCB T regulatory and CD3+ T effector cells in double UCB transplantation | Not open yet |
| NCT00224354 | 1 | Baylor College of Medicine | Safety and efficacy of deleting Tregs with IL-2 immunotoxin directed to the CD25 antigen and administration of autologous gene-modified tumor cells in patients with CLL | Completed |
| NCT01067287 | 2 | Dana-Farber Cancer Institute | Safety and efficacy of the blockage of PD-1 in conjunction with the dendritic Cell/myeloma vaccines after autoHCT | Recruiting |
| NCT01251952 | 1 | Barbara Ann Karmanos Cancer Institute | Feasibility and safety of giving 2 doses of denileukin diftitox in patients with MM early after autoHCT | Recruiting |
Most of the studies are at the stage of phase 2 and in the setting of allogeneic stem cell transplantation or cellular therapy.
alloHCT indicates allogeneic HSC transplantation; AML, acute myelogenous leukemia; autoHCT, autologous HSC transplantation; CLL, chronic lymphocytic leukemia; DLI, donor lymphocyte infusion; GVT, graft-versus-tumor; MM, multiple myeloma; MTD, maximal tolerated dose; NK, natural killer; PD-1, programmed death-1; and UCB, umbilical cord blood.