NCT00714259

Non-Myeloablative Allogeneic HSCT From HLA Matched Related or Unrelated Donors for the Treatment of Low Grade B Cell Malignancies

UAB 0775 Phase II Trial of Non-Myeloablative Allogeneic Hematopoietic Cell Transplantation Protocol From HLA Matched Related Donors for The Treatment of Patients With Low Grade B Cell Malignancies

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 19 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

A non-myeloablative treatment strategy and uniform selection criteria will enable patients with a variety of low grade B-Cell malignancies to attain long term disease control without unacceptably high treatment related mortality.

Detailed description

Non myeloablative transplant aims to achieve the immunological advantage of graft versus tumor effect as conventional myeloablative therapy without causing high treatment related toxicities. Non myeloablative transplant has been gaining wider acceptance as a way to achieve longer disease free and over all survival in patients with low grade B-cell malignancies, which otherwise is an incurable disease. Recent studies of non-myeloablative HSCT have demonstrated the powerful effect of graft versus leukemia alone against myeloma and other malignant B-cell malignancies if the transplant is performed for low grade, low volume disease.

Conditions

• Multiple Myeloma
• CLL / SLL
• Non Hodgkin's Lymphoma
• Waldenstroms
• Mantle Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Fludarabine	Fludarabine 30 mg/m2/day x 3 days
RADIATION	Total Body Irradiation	TBI 200cGy x1 dose on transplant day
OTHER	Infusion of Stem Cells	On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10\*6 CD34+ cells per kilogram of recipient weight.

Timeline

• Start date: 2008-07-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2008-07-14
• Last updated: 2017-07-24
• Results posted: 2017-05-04

Locations

1 site across 1 country: United States