NCT01666080

Second or Greater Allogeneic Hematopoietic Stem Cell Transplant Using Reduced Intensity Conditioning (RIC)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

Summary

This is a treatment guideline for a second or greater allogeneic hematopoietic stem cell transplant (HSCT) using a reduced intensity conditioning (RIC) in patients with non-malignant or malignant diseases. This regimen, consisting of busulfan, fludarabine, and low dose total body irradiation (TBI), is designed to promote engraftment in patients who failed to achieve an acceptable level of donor-derived engraftment following a previous allogeneic HCT.

Detailed description

There is no research element except the collection of routine clinical data. Patients will consent to allow routine clinical data to be collected and maintained in OnCore, the Masonic Cancer Center's (MCC) clinical database, and specific transplant related endpoints in the University Of Minnesota Blood and Bone Marrow Database as part of the historical database maintained by the department.

Conditions

• Hematologic Disorders
• Hemoglobinopathies
• Immunodeficiencies

Interventions

Type	Name	Description
DRUG	Busulfan	0.4 mg/kg (0.5 mg/kg if \<4 years of age) intravenously (IV) every 6 hours on Days -8 and -7.
DRUG	Fludarabine	40 mg/m\^2 intravenously (IV) over 1 hour on days -6 through -2.
RADIATION	Total body irradiation	200 cGy on Day -1
BIOLOGICAL	Stem cell transplant	stem cell infusion on day 0
DRUG	Keppra	Keppra will be given for seizure prophylaxis during busulfan administration as per the standard institutional protocol.

Timeline

• Start date: 2012-08-01
• Primary completion: 2026-06-01
• Completion: 2027-06-01
• First posted: 2012-08-16
• Last updated: 2025-07-24

Locations

1 site across 1 country: United States