NCT02765997

StemRegenin-1 Expanded vs Unexpanded UCB for High Risk Heme Malignancies

Single-Center, Open Label, Randomized Trial Comparing StemRegenin-1 Expanded Versus Unmanipulated Umbilical Cord Blood Transplantation In Patients With High-Risk Malignancy

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 2 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

This is an open label, interventional, randomized phase II trial comparing StemRegenin-1 (SR-1) cultured umbilical cord blood (experimental arm) to unmanipulated umbilical cord blood (standard of care arm) transplantation after a myeloablative CY/FLU/TBI conditioning. A 2:1 randomization will be employed with a higher chance of being assigned to the experimental arm.

Conditions

• Acute Myeloid Leukemia
• Acute Lymphocytic Leukemia
• Chronic Myelogenous Leukemia
• Myelodysplasia

Interventions

Type	Name	Description
BIOLOGICAL	Unmanipulated UCB	Unmanipulated UCB infusion given on Day 0. All patients will receive the same conditioning and immunoprophylaxis for the prevention of acute and chronic GVHD, previously demonstrated to offer the best outcomes in recipients of partially HLA matched UCB. Standard supportive care, including the use of Neupogen \[G-CSF\] and prophylactic anti-bacterial, protozoal, viral and fungal agents, will also be prescribed. Supportive care will be modified throughout the transplant course at the treating physician's judgement.
BIOLOGICAL	SR-1 UCB	SR-1 UCB infusion given on Day 0. All patients will receive the same conditioning and immunoprophylaxis for the prevention of acute and chronic GVHD, previously demonstrated to offer the best outcomes in recipients of partially HLA matched UCB. Standard supportive care, including the use of Neupogen \[G-CSF\] and prophylactic anti-bacterial, protozoal, viral and fungal agents, will also be prescribed. Supportive care will be modified throughout the transplant course at the treating physician's judgement.

Timeline

• Start date: 2017-04-01
• Primary completion: 2020-06-01
• Completion: 2022-06-01
• First posted: 2016-05-09
• Last updated: 2017-12-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study