Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00045305
Status:
COMPLETED
Last Update Posted:
2023-06-28
First Post:
2002-09-06
Brief Title:
Reduced-Intensity Regimen Before Donor Bone Marrow Transplant in Treating Patients With Myelodysplastic Syndromes
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
A Phase II Study of Reduced Intensity Allogeneic Bone Marrow Transplant for the Treatment of Myelodysplastic Syndromes
Status:
COMPLETED
Status Verified Date:
2023-06
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 Photopheresis treats the patients blood with drugs and ultraviolet light outside the body and kills the white blood cells Giving photopheresis pentostatin and radiation therapy before a donor bone marrow or stem cell transplant helps stop the patients immune system from rejecting the donors stem cells The donated stem cells may replace the patients immune system 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 bodys normal cells Giving pentostatin before transplant and cyclosporine or mycophenolate mofetil after transplant may stop this from happening
PURPOSE This phase II trial is studying how well giving pentostatin together with photopheresis and total-body irradiation work before donor bone marrow transplant in treating patients with myelodysplastic syndromes
PURPOSE This phase II trial is studying how well giving pentostatin together with photopheresis and total-body irradiation work before donor bone marrow transplant in treating patients with myelodysplastic syndromes
Detailed Description:
OBJECTIVES
Determine the complete response rate in patients with myelodysplastic syndromes treated with reduced-intensity allogeneic bone marrow transplantation including photopheresis total body irradiation and pentostatin
Determine the disease-free and overall survival of patients treated with this regimen
Determine the engraftment rate of donor cells in patients treated with this regimen
Determine the extent and duration of acute and chronic graft-versus-host disease in patients treated with this regimen
Determine the toxicity of this regimen in these patients
OUTLINE This is a single-arm two-stage multicenter phase II study
Preparative Regimen Patients undergo photopheresis using methoxsalen on days -7 and -6 and receive pentostatin intravenously IV continuously on days -5 and -4 Total body irradiation is administered on days -3 and -2 for a total of 3 doses
Transplantation Allogeneic bone marrow or peripheral blood stem cells are infused on day 0
Acute graft-vs-host-disease GVHD prophylaxis Patients receive cyclosporine IV on days -1 to 30 and then orally every 12 hours Cyclosporine dose is then tapered beginning after day 50 and continuing for 6 months in the absence of GVHD Once cyclosporine dose is significantly decreased oral mycophenolate mofetil MMF is then administered twice a day MMF dose is then tapered for 12 months in the absence of GVHD Patients also receive methotrexate IV on days 1 and 3
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 33 patients would be accrued for this study within 21 years
Determine the complete response rate in patients with myelodysplastic syndromes treated with reduced-intensity allogeneic bone marrow transplantation including photopheresis total body irradiation and pentostatin
Determine the disease-free and overall survival of patients treated with this regimen
Determine the engraftment rate of donor cells in patients treated with this regimen
Determine the extent and duration of acute and chronic graft-versus-host disease in patients treated with this regimen
Determine the toxicity of this regimen in these patients
OUTLINE This is a single-arm two-stage multicenter phase II study
Preparative Regimen Patients undergo photopheresis using methoxsalen on days -7 and -6 and receive pentostatin intravenously IV continuously on days -5 and -4 Total body irradiation is administered on days -3 and -2 for a total of 3 doses
Transplantation Allogeneic bone marrow or peripheral blood stem cells are infused on day 0
Acute graft-vs-host-disease GVHD prophylaxis Patients receive cyclosporine IV on days -1 to 30 and then orally every 12 hours Cyclosporine dose is then tapered beginning after day 50 and continuing for 6 months in the absence of GVHD Once cyclosporine dose is significantly decreased oral mycophenolate mofetil MMF is then administered twice a day MMF dose is then tapered for 12 months in the absence of GVHD Patients also receive methotrexate IV on days 1 and 3
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 33 patients would be accrued for this study within 21 years
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA021115 | NIH | Eastern Cooperative Oncology Group ECOG | httpsreporternihgovquickSearchU10CA021115 |
| E1902 | OTHER | None | None |