Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00303719
Status:
TERMINATED
Last Update Posted:
2020-05-12
First Post:
2006-03-15
Brief Title:
Allogeneic Bone Marrow Transplantation Using Less Intensive Therapy
Sponsor:
Masonic Cancer Center University of Minnesota
Organization:
Masonic Cancer Center University of Minnesota
Study Overview
Official Title:
Allogeneic Bone Marrow Transplantation Using Less Intensive Therapy
Status:
TERMINATED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
IRB Study Closure
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy and radiation therapy or that have become cancer Sometimes the transplanted cells from a donor can make an immune response against the bodys normal cells Giving cyclophosphamide and fludarabine together with total-body irradiation followed by cyclosporine and mycophenolate mofetil before the transplant may stop this from happening
PURPOSE This clinical trial is studying how well giving combination chemotherapy together with radiation therapy followed by cyclosporine and mycophenolate mofetil works in treating patients who are undergoing a donor stem cell transplant for hematologic cancer metastatic breast cancer or kidney cancer
PURPOSE This clinical trial is studying how well giving combination chemotherapy together with radiation therapy followed by cyclosporine and mycophenolate mofetil works in treating patients who are undergoing a donor stem cell transplant for hematologic cancer metastatic breast cancer or kidney cancer
Detailed Description:
OBJECTIVES
Determine if a nonmyeloablative regimen comprising cyclophosphamide fludarabine and radiotherapy followed by cyclosporine and mycophenolate mofetil provides a prompt and durable donor engraftment in patients with hematologic malignancies or kidney cancer who are undergoing allogeneic stem cell transplantation
Determine the safety of this nonmyeloablative transplantation regimen in these patients
Determine the risk of graft-versus-host-disease in patients treated with this regimen
Determine the antineoplastic potency of nonmyeloablative stem cell transplantation in patients treated with this regimen
Determine the effect of lower doses of daily fludarabine on treatment-related mortality TRM OUTLINE Patients are stratified according to risk standard vs high
Preparative regimen Patients receive cyclophosphamide intravenously IV over 2 hours on day -6 and fludarabine IV over 1 hour on days -6 to -2 Patients undergo total body irradiation on day -1 Some patients also receive anti-thymocyte globulin ATG IV every 12 hours on days -6 to -4 Patients who receive ATG include the following
Related donor recipients who have not received combination chemotherapy within the past 6 months
Unrelated donor recipients who have not received combination chemotherapy within the past 3 months
Unrelated donor recipients who have received only 1 induction course for the treatment of acute lymphoblastic leukemia ALL acute myeloid leukemia AML myelodysplastic syndromes MDS or blastic phase chronic myelogenous leukemia CML NOTE Patients who underwent prior autologous stem cell transplantation in the past year do not receive ATG
Allogeneic peripheral blood stem cell transplantation PBSCT Patients undergo allogeneic PBSCT on day 0
Graft-versus-host-disease prophylaxis Patients receive cyclosporine IV over 2 hours beginning on day -3 and continuing until at least day 100 Patients also receive mycophenolate mofetil IV or orally twice daily on days -3 to 30
Donor lymphocyte infusion DLI Patients without active GVHD but deteriorating donor chimerism may receive DLI IV over 2 hours
After completion of study treatment patients are followed periodically for 2 years
PROJECTED ACCRUAL A total of 300 patients will be accrued for this study
Determine if a nonmyeloablative regimen comprising cyclophosphamide fludarabine and radiotherapy followed by cyclosporine and mycophenolate mofetil provides a prompt and durable donor engraftment in patients with hematologic malignancies or kidney cancer who are undergoing allogeneic stem cell transplantation
Determine the safety of this nonmyeloablative transplantation regimen in these patients
Determine the risk of graft-versus-host-disease in patients treated with this regimen
Determine the antineoplastic potency of nonmyeloablative stem cell transplantation in patients treated with this regimen
Determine the effect of lower doses of daily fludarabine on treatment-related mortality TRM OUTLINE Patients are stratified according to risk standard vs high
Preparative regimen Patients receive cyclophosphamide intravenously IV over 2 hours on day -6 and fludarabine IV over 1 hour on days -6 to -2 Patients undergo total body irradiation on day -1 Some patients also receive anti-thymocyte globulin ATG IV every 12 hours on days -6 to -4 Patients who receive ATG include the following
Related donor recipients who have not received combination chemotherapy within the past 6 months
Unrelated donor recipients who have not received combination chemotherapy within the past 3 months
Unrelated donor recipients who have received only 1 induction course for the treatment of acute lymphoblastic leukemia ALL acute myeloid leukemia AML myelodysplastic syndromes MDS or blastic phase chronic myelogenous leukemia CML NOTE Patients who underwent prior autologous stem cell transplantation in the past year do not receive ATG
Allogeneic peripheral blood stem cell transplantation PBSCT Patients undergo allogeneic PBSCT on day 0
Graft-versus-host-disease prophylaxis Patients receive cyclosporine IV over 2 hours beginning on day -3 and continuing until at least day 100 Patients also receive mycophenolate mofetil IV or orally twice daily on days -3 to 30
Donor lymphocyte infusion DLI Patients without active GVHD but deteriorating donor chimerism may receive DLI IV over 2 hours
After completion of study treatment patients are followed periodically for 2 years
PROJECTED ACCRUAL A total of 300 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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 0108M06725 | OTHER | IRB University of Minnesota | None |
| UMN-MT2001-10 | OTHER | None | None |