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Clinical Trial Summary

This is a unique dose-escalation trial that will titrate doses of umbilical cord blood (UCB) Treg and CD3+ Teff cells with the goal of infusing as many CD3+ Teff cells as possible without conferring grade II-IV acute graft-versus-host disease (GVHD).

In this study, the investigators propose to add UCB Treg and UCB CD3+ Teff cells to the two TCD UCB donor units with the goal of transplanting as many CD3+ Teff cells as possible without reintroducing risk of acute GVHD. The investigators hypothesize that Treg will permit the reintroduction of CD3+ Teff cells that will provide a bridge while awaiting HSC T cell recovery long term. The co-infusion of Treg will prevent GVHD without the need for prolonged pharmacologic immunosuppression.


Clinical Trial Description

Based on prior studies, the first patient will start at lowest dose combination (3 x 10^6/kg of Treg and 3 x 10^6/kg of CD3+ Teff cells).

One patient will be entered at each level with a minimum of 35 days to observe the patient prior to moving to the next dose level. (1) If GVHD does not occur, a "successful step", then the CD3+ Teff cell dose will increase to the next higher level for the next patient; (2) If GVHD occurs, a "failed step", then Treg dose will increase to the next higher level for the next patient. It would take a minimum of 5 (if no GVHD) and maximum of 9 patients (if GVHD is observed at each level) to complete all Treg:CD3+ Teff cell combinations.

An additional 10 patients will be enrolled to verify that this reflects the optimal combination and evaluate its safety profile. ;


Study Design


Related Conditions & MeSH terms

  • Acute Lymphocytic Leukemia
  • Acute Myeloid Leukemia
  • Anemia, Refractory, with Excess of Blasts
  • Blast Crisis
  • Burkitt Lymphoma
  • Burkitt's Lymphoma
  • Chronic Lymphocytic Leukemia
  • Chronic Myelogenous Leukemia in Blast Crisis
  • Chronic Myeloproliferative Disease
  • Follicular Lymphoma
  • Hematologic Malignancy
  • High Grade Non-Hodgkin's Lymphoma
  • Large Cell Non-Hodgkin's Lymphoma
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Leukemia, Myeloid
  • Leukemia, Myeloid, Acute
  • Lymphoblastic Lymphoma
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, B-Cell, Marginal Zone
  • Lymphoma, Follicular
  • Lymphoma, Mantle-Cell
  • Lymphoma, Non-Hodgkin
  • Lymphoplasmacytic Lymphoma
  • Mantle-Cell Lymphoma
  • Marginal Zone B-cell Lymphoma
  • Myeloproliferative Disorders
  • Neoplasms
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Prolymphocytic Lymphoma
  • Small Lymphocytic Lymphoma
  • Waldenstrom Macroglobulinemia

NCT number NCT01163201
Study type Interventional
Source Masonic Cancer Center, University of Minnesota
Contact
Status Withdrawn
Phase Phase 1/Phase 2
Start date January 2014
Completion date January 2015

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