Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00068523
Status:
COMPLETED
Last Update Posted:
2020-07-27
First Post:
2003-09-10
Brief Title:
Ultraviolet-B Light Therapy and Allogeneic Stem Cell Transplantation in Treating Patients With Hematologic Malignancies
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
Immunomodulation by Ultraviolet B-Irradiation UVB to Facilitate Allogeneic Stem Cell Transplantation for Treatment of Hematologic Malignancies
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy Sometimes the transplanted cells from a donor are rejected by the bodys normal cells Ultraviolet-B light therapy given before and after allogeneic stem cell transplantation may help prevent this from happening
PURPOSE Clinical trial to study the effectiveness of combining ultraviolet-B light therapy with allogeneic stem cell transplantation in treating patients who have hematologic malignancies
PURPOSE Clinical trial to study the effectiveness of combining ultraviolet-B light therapy with allogeneic stem cell transplantation in treating patients who have hematologic malignancies
Detailed Description:
OBJECTIVES
Primary
Determine the safety of ultraviolet-B light therapy and allogeneic peripheral blood stem cell transplantation in patients with hematologic malignancies by demonstrating 100-day mortality no greater than 15 and 1-year mortality no greater than 40
Determine the frequency of treatment-related toxicity leading to death and frequency of disease relapse resulting in death in patients treated with this regimen
Determine the incidence and severity of acute and chronic graft-versus-host disease in patients treated with this regimen
Secondary
Determine the rates of donor allogeneic hematologic engraftment in patients treated with this regimen
Determine the rate and quality of immune reconstitution in the peripheral blood and the composition of immune cells in the skin before and after transplantation in these patients
Determine the event-free and overall survival of patients treated with this regimen
OUTLINE
Preparative regimen Patients receive fludarabine IV over 30 minutes on days -8 to -4 and cyclophosphamide IV over 1 hour on days -3 to -2 Patients also receive anti-thymocyte globulin IV over 4 hours on days -2 to -1 Patients undergo ultraviolet-B UVB light therapy every other day between days -10 and -2 for a total of 3 days
Allogeneic peripheral blood stem cell PBSC transplantation Patients undergo PBSC transplantation on day 0
Graft-versus-host disease prophylaxis Patients receive oral cyclosporine on days -1 to 100 and methylprednisolone oral or IV on days 5-15
Posttransplantation UVB light therapy Following PBSC transplantation patients undergo UVB light therapy twice weekly on week 1 at least 1 day apart and three times weekly on weeks 2-4
Donor lymphocyte infusion is performed per institutional guidelines for patients in whom emerging donor chimerism post allogeneic PBSC transplantation is not progressing consistently below 50 during first 3 months for whom donor chimerism is receding to below 25 despite cessation of cyclosporine or who relapse within 24 months after allografting
Patients are followed at least monthly for 3 months and then at 6 12 18 and 24 months
PROJECTED ACCRUAL A total of 23-36 patients will be accrued for this study
Primary
Determine the safety of ultraviolet-B light therapy and allogeneic peripheral blood stem cell transplantation in patients with hematologic malignancies by demonstrating 100-day mortality no greater than 15 and 1-year mortality no greater than 40
Determine the frequency of treatment-related toxicity leading to death and frequency of disease relapse resulting in death in patients treated with this regimen
Determine the incidence and severity of acute and chronic graft-versus-host disease in patients treated with this regimen
Secondary
Determine the rates of donor allogeneic hematologic engraftment in patients treated with this regimen
Determine the rate and quality of immune reconstitution in the peripheral blood and the composition of immune cells in the skin before and after transplantation in these patients
Determine the event-free and overall survival of patients treated with this regimen
OUTLINE
Preparative regimen Patients receive fludarabine IV over 30 minutes on days -8 to -4 and cyclophosphamide IV over 1 hour on days -3 to -2 Patients also receive anti-thymocyte globulin IV over 4 hours on days -2 to -1 Patients undergo ultraviolet-B UVB light therapy every other day between days -10 and -2 for a total of 3 days
Allogeneic peripheral blood stem cell PBSC transplantation Patients undergo PBSC transplantation on day 0
Graft-versus-host disease prophylaxis Patients receive oral cyclosporine on days -1 to 100 and methylprednisolone oral or IV on days 5-15
Posttransplantation UVB light therapy Following PBSC transplantation patients undergo UVB light therapy twice weekly on week 1 at least 1 day apart and three times weekly on weeks 2-4
Donor lymphocyte infusion is performed per institutional guidelines for patients in whom emerging donor chimerism post allogeneic PBSC transplantation is not progressing consistently below 50 during first 3 months for whom donor chimerism is receding to below 25 despite cessation of cyclosporine or who relapse within 24 months after allografting
Patients are followed at least monthly for 3 months and then at 6 12 18 and 24 months
PROJECTED ACCRUAL A total of 23-36 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None