Clinical Trials Directory

Trials / Terminated

TerminatedNCT02991898

Adoptive TReg Cell for Suppression of aGVHD After UCB HSCT for Heme Malignancies

Adoptive Transfer of T Regulatory Cell for Suppression of Acute Graft-vs-Host-Disease After an Umbilical Cord Blood Transplant for Hematologic Malignancies

Status
Terminated
Phase
Phase 2
Study type
Interventional
Enrollment
3 (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 single center pilot study of a non-myeloablative umbilical cord blood transplant for the treatment of a hematological malignancy with a single infusion of T regulatory (Treg) given shortly after UCB transplantation.

Conditions

Interventions

TypeNameDescription
BIOLOGICALInfusion of TregAllopurinol on day -7 to day 0 Cyclophosphamide 50 mg/kg IV over 2 hours on day -6 Fludarabine 30mg/m2 IV over 1 hour on day -6, -5, -4, -3, and -2 Total Body Irradiation 200 cGy as a single dose Sirolimus 8mg-12mg oral loading dose followed by single dose 4mg/day. Levels are to be monitored 3 times/week in the first week, weekly until day +60, and as clinically indicated until day +100 post-transplantation. Mycophenolate Mofetil (MMF) 3 gram/day IV/PO divided in 2 or 3 doses. Stop MMF at day +30 or 7 days after neutrophil recovery, whichever day is later, if no acute GVHD. DUCBT followed Tregs - double umbilical cord blood transplant (FIRST) followed by the Treg cell infusion (SECOND) no sooner than 1 hour, but within 24 hours after the 2nd cord blood infusion.

Timeline

Start date
2017-02-16
Primary completion
2019-06-20
Completion
2019-06-20
First posted
2016-12-14
Last updated
2020-09-29
Results posted
2020-07-24

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT02991898. Inclusion in this directory is not an endorsement.