Clinical Trials Directory

Trials / Completed

CompletedNCT00119392

Yttrium Y 90 Ibritumomab Tiuxetan, Fludarabine, Radiation Therapy, and Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

A Phase II Trial Evaluating the Safety and Efficacy of Non-myeloablative 90Y-Ibritumomab Tiuxetan (Anti-CD20) Antibody With Fludarabine, Low-Dose Total Body Irradiation (TBI) and HLA Matched Allogeneic Transplantation for Relapsed B-cell Lymphoma

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
42 (actual)
Sponsor
Fred Hutchinson Cancer Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can block find cancer cells and either kill them or carry cancer-killing substances to them without harming normal cells. Giving monoclonal antibodies, low doses of chemotherapy, such as fludarabine phosphate, and low dose total-body radiation therapy before a donor peripheral stem cell transplant helps stop the growth of cancer cells and also stops 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). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine or mycophenolate mofetil after the transplant may stop this from happening

Detailed description

PRIMARY OBJECTIVES: I. To assess the feasibility, safety, and potential efficacy of treating patients with B-Cell non-Hodgkin lymphoma (NHL) with 90Y-ibritumomab tiuxetan, combined with HLA-matched related or unrelated donor hematopoietic cell transplantation. OUTLINE: Patients receive rituximab intravenously (IV) followed by, no more than 4 hours later, indium In 111 ibritumomab tiuxetan (for imaging) IV over 10 minutes on day -21. Patients undergo gamma camera imaging on day -19. Patients receive rituximab IV followed by, no more than 4 hours later, yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day -14. Patients also receive fludarabine phosphate IV over 30-60 minutes on days -7 to -5 and undergo low-dose total-body irradiation (TBI) on day 0. After TBI, patients undergo allogeneic peripheral blood stem cell transplantation (PBSCT) on day 0. Patients who undergo PBSCT from a related donor receive oral cyclosporine twice daily on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease (GVHD). These patients also receive oral mycophenolate mofetil twice daily on days 0 to 27. Patients who undergo PBSCT from an unrelated donor receive oral cyclosporine twice daily on days -3 to 100 followed by a taper over 11 weeks in the absence of GVHD. These patients also receive oral mycophenolate mofetil three times daily on days 0 to 40 followed by a taper to day 96. After completion of study treatment, patients are followed up at 1, 3, 6, and 12 months, and then annually thereafter.

Conditions

Interventions

TypeNameDescription
BIOLOGICALrituximabGiven IV
DRUGcyclosporineGiven orally
DRUGfludarabine phosphateGiven IV
DRUGmycophenolate mofetilGiven orally
RADIATIONyttrium Y 90 ibritumomab tiuxetanGiven IV
PROCEDUREperipheral blood stem cell transplantationUndergo transplantation
PROCEDUREallogeneic hematopoietic stem cell transplantationUndergo transplantation
RADIATIONtotal-body irradiationUndergo TBI

Timeline

Start date
2004-06-01
Primary completion
2009-07-01
Completion
2016-04-23
First posted
2005-07-13
Last updated
2018-06-29
Results posted
2017-05-24

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00119392. Inclusion in this directory is not an endorsement.