Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00044954
Status:
COMPLETED
Last Update Posted:
2019-09-17
First Post:
2002-09-06
Brief Title:
Total-Body Irradiation Fludarabine and Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
Low Dose Total-Body Irradiation And Fludarabine Followed By HLA Matched Allogeneic Stem Cell Transplantation For Hematologic Malgnancies - A Multi-Center Study
Status:
COMPLETED
Status Verified Date:
2019-09
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 Radiation therapy uses high-energy x-rays to damage cancer cells Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Combining chemotherapy with donor peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining total-body irradiation with fludarabine and donor peripheral stem cell transplantation in treating patients who have hematologic cancer
PURPOSE Phase II trial to study the effectiveness of combining total-body irradiation with fludarabine and donor peripheral stem cell transplantation in treating patients who have hematologic cancer
Detailed Description:
OBJECTIVES
Determine the response rate and duration of response in patients with low-risk hematologic malignancies treated with low-dose total-body irradiation TBI and fludarabine followed by HLA-matched allogeneic stem cell transplantation followed by a slow immunosuppression taper and donor leukocyte infusions DLI
Determine the response rate and duration of response in patients with high-risk hematologic malignancies treated with low-dose TBI and fludarabine followed by HLA-matched allogeneic stem cell transplantation followed by a faster immunosuppression taper and DLI
Determine the incidence and extent of graft-versus-host disease regimen-related toxicity and engraftment in patients treated with these regimens
Assess the quality of life of patients treated with these regimens
OUTLINE This is a multicenter study Patients are assigned to 1 of 2 groups high-risk vs low-risk hematologic malignancy The high-risk group includes acute myelogenous leukemia myelodysplastic syndromes accelerated phase chronic myelogenous leukemia CML second chronic phase CML and non-Hodgkins lymphoma The low-risk group includes Hodgkins lymphoma first chronic phase CML multiple myeloma and chronic lymphocytic leukemia
Patients receive fludarabine IV on days -4 to -2 Patients undergo total-body irradiation on day 0 followed by allogeneic stem cell transplantation Patients also receive oral mycophenolate mofetil on days 0-28
High-risk patients receive oral cyclosporine twice daily on days -2 to day 60 Patients with persistent disease T-cell chimerism and no graft-vs-host disease GVHD on day 90 receive up to 3 doses of donor leukocyte infusion DLI over the next 4 months
Low-risk patients receive oral cyclosporine twice daily on days -2 to day 150 Patients with persistent disease T-cell chimerism and no GVHD on day 180 receive up to 3 doses of DLI over the next 4 months
Quality of life is assessed at baseline and at 1 3 6 9 12 18 and 24 months
Patients are followed at 1 3 6 9 and 12 months and then annually for 2 years
PROJECTED ACCRUAL A total of 120 patients 60 per group will be accrued for this study
Determine the response rate and duration of response in patients with low-risk hematologic malignancies treated with low-dose total-body irradiation TBI and fludarabine followed by HLA-matched allogeneic stem cell transplantation followed by a slow immunosuppression taper and donor leukocyte infusions DLI
Determine the response rate and duration of response in patients with high-risk hematologic malignancies treated with low-dose TBI and fludarabine followed by HLA-matched allogeneic stem cell transplantation followed by a faster immunosuppression taper and DLI
Determine the incidence and extent of graft-versus-host disease regimen-related toxicity and engraftment in patients treated with these regimens
Assess the quality of life of patients treated with these regimens
OUTLINE This is a multicenter study Patients are assigned to 1 of 2 groups high-risk vs low-risk hematologic malignancy The high-risk group includes acute myelogenous leukemia myelodysplastic syndromes accelerated phase chronic myelogenous leukemia CML second chronic phase CML and non-Hodgkins lymphoma The low-risk group includes Hodgkins lymphoma first chronic phase CML multiple myeloma and chronic lymphocytic leukemia
Patients receive fludarabine IV on days -4 to -2 Patients undergo total-body irradiation on day 0 followed by allogeneic stem cell transplantation Patients also receive oral mycophenolate mofetil on days 0-28
High-risk patients receive oral cyclosporine twice daily on days -2 to day 60 Patients with persistent disease T-cell chimerism and no graft-vs-host disease GVHD on day 90 receive up to 3 doses of donor leukocyte infusion DLI over the next 4 months
Low-risk patients receive oral cyclosporine twice daily on days -2 to day 150 Patients with persistent disease T-cell chimerism and no GVHD on day 180 receive up to 3 doses of DLI over the next 4 months
Quality of life is assessed at baseline and at 1 3 6 9 12 18 and 24 months
Patients are followed at 1 3 6 9 and 12 months and then annually for 2 years
PROJECTED ACCRUAL A total of 120 patients 60 per group will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| NCI-V02-1705 | None | None | None |
| UTSMC-0799296 | None | None | None |
| AMGEN-UTSMC-0799296 | None | None | None |
| IBMTR-SC-00-031 | None | None | None |
| ROCHE-UTSMC-0799296 | None | None | None |
| SPRI-UTSMC-0799296 | None | None | None |