NCT00963872

Donor Umbilical Cord Blood Transplant After Fludarabine Phosphate, Cyclophosphamide, and Total-Body Irradiation in Treating Patients With High-Risk Hematologic Cancer

MT2008-15: Transplantation of Unrelated Donor Umbilical Cord Blood in Patients With Hematological Malignancies Using a Nonmyeloablative Preparative Regimen and Priming With Complement 3a Fragment (C3a)

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Giving low doses of chemotherapy and total-body irradiation before a donor umbilical cord blood transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). PURPOSE: This phase I trial is studying the safety of donor umbilical cord blood transplant after fludarabine phosphate, cyclophosphamide, and total-body irradiation in treating patients with high-risk hematologic cancer (now closed). The Phase II part of this trial is studying whether priming one of two UCB units with C3a facilitates engraftment of the treated unit.

Detailed description

OUTLINE: * Nonmyeloablative preparative regimen: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 2 hours on day -6. Patients then undergo total-body irradiation on day -1. Some patients also receive anti-thymocyte globulin IV every 12 hours on days -6, -5, and -4. * Umbilical cord blood (UCB) transplantation: Patients undergo unmanipulated UCB transplantation followed by complement 3a fragment primed UCB transplantation on day 0. Treatment for graft-vs-host disease prophylaxis is also given. After completion of study therapy, patients are followed up periodically for up to 2 years.

Conditions

• Leukemia
• Lymphoma
• Multiple Myeloma
• Myelodysplastic Syndromes

Interventions

Type	Name	Description
DRUG	cyclophosphamide	50 mg/kg intravenously (IV) over 2 hours on Day -6.
DRUG	fludarabine phosphate	40 mg/m\^2 over 1 hour on Days -6 through -2.
RADIATION	Total body irradiation	200 cGy on Day -1
BIOLOGICAL	Umbilical cord blood unit with C3a fragment	On Day 0, the C3a primed UCB unit will be infused intravenously SECOND, within 30 minutes of the completion of the infusion of the unmanipulated UCB unit, through a central line without in-line filtration in a manner identical to the unmanipulated UCB unit.
BIOLOGICAL	Unmanipulated UCB Unit	On Day 0, the unmanipulated UCB unit will be infused FIRST through a central line without in-line filtration per institutional guidelines.

Timeline

• Start date: 2010-03-01
• Primary completion: 2012-08-01
• Completion: 2013-08-01
• First posted: 2009-08-24
• Last updated: 2017-12-28
• Results posted: 2015-11-10

Locations

1 site across 1 country: United States