Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00078858
Status:
COMPLETED
Last Update Posted:
2020-01-18
First Post:
2004-03-08
Brief Title:
Mycophenolate Mofetil and Cyclosporine in Reducing Graft-Versus-Host Disease in Patients With Hematologic Malignancies or Metastatic Kidney Cancer Undergoing Donor Stem Cell Transplant
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Prolonged Mycophenolate Mofetil and Truncated Cyclosporine Postgrafting Immunosuppression to Reduce Life-Threatening GVHD After Unrelated Donor Peripheral Blood Cell Transplantation Using Nonmyeloablative Conditioning for Patients With Hematologic Malignancies and Renal Cell Carcinoma - A Multi-Center Trial
Status:
COMPLETED
Status Verified Date:
2019-02
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:
This phase III trial studies whether stopping cyclosporine before mycophenolate mofetil is better at reducing the risk of life-threatening graft-versus-host disease GVHD than the previous approach where mycophenolate mofetil was stopped before cyclosporine The other reason this study is being done because at the present time there are no curative therapies known outside of stem cell transplantation for these types of cancer Because of age or underlying health status patients may have a higher likelihood of experiencing harm from a conventional blood stem cell transplant This study tests whether this new blood stem cell transplant method can be made safer by changing the order and length of time that immune suppressing drugs are given after transplant
Detailed Description:
PRIMARY OBJECTIVES
I To determine whether the incidence of life-threatening GVHD can be reduced after unrelated donor peripheral blood mononuclear cell PBMC hematopoietic cell transplantation HCT using nonmyeloablative conditioning with earlier discontinuation of cyclosporine CSP and extended administration of mycophenolate mofetil MMF in patients with hematologic malignancies and metastatic renal cell carcinoma
SECONDARY OBJECTIVES
I To compare the incidence of acute and chronic GVHD to protocols 1463 and 1641
II To compare the utilization of corticosteroids to protocols 1463 and 1641
III To compare survival to that achieved under protocol 1463 and 1641
OUTLINE
CONDITIONING Patients receive fludarabine phosphate intravenously IV over 30 minutes on days -4 to -2 and undergo total-body irradiation TBI on day 0
TRANSPLANTATION Patients undergo allogeneic PBMC transplant on day 0
IMMUNOSUPPRESSION Patients receive cyclosporine orally PO twice daily BID on days -3 to 80 with taper to day 150 and mycophenolate mofetil PO or IV thrice daily TID on days 0-30 BID on days 31-150 and then taper to day 180 Treatment continues in the absence of unacceptable toxicity
After completion of study treatment patients are followed up periodically for 24 months and then yearly for 5 years
I To determine whether the incidence of life-threatening GVHD can be reduced after unrelated donor peripheral blood mononuclear cell PBMC hematopoietic cell transplantation HCT using nonmyeloablative conditioning with earlier discontinuation of cyclosporine CSP and extended administration of mycophenolate mofetil MMF in patients with hematologic malignancies and metastatic renal cell carcinoma
SECONDARY OBJECTIVES
I To compare the incidence of acute and chronic GVHD to protocols 1463 and 1641
II To compare the utilization of corticosteroids to protocols 1463 and 1641
III To compare survival to that achieved under protocol 1463 and 1641
OUTLINE
CONDITIONING Patients receive fludarabine phosphate intravenously IV over 30 minutes on days -4 to -2 and undergo total-body irradiation TBI on day 0
TRANSPLANTATION Patients undergo allogeneic PBMC transplant on day 0
IMMUNOSUPPRESSION Patients receive cyclosporine orally PO twice daily BID on days -3 to 80 with taper to day 150 and mycophenolate mofetil PO or IV thrice daily TID on days 0-30 BID on days 31-150 and then taper to day 180 Treatment continues in the absence of unacceptable toxicity
After completion of study treatment patients are followed up periodically for 24 months and then yearly for 5 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 |
|---|---|---|---|
| P01CA018029 | NIH | Fred Hutchinson Cancer Research CenterUniversity of Washington Cancer Consortium | httpsreporternihgovquickSearchP01CA018029 |
| NCI-2012-00668 | REGISTRY | None | None |
| 166800 | OTHER | None | None |
| P30CA015704 | NIH | None | None |