Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00105001
Status:
COMPLETED
Last Update Posted:
2019-10-30
First Post:
2005-03-03
Brief Title:
Tacrolimus and Mycophenolate Mofetil With or Without Sirolimus in Preventing Acute Graft-Versus-Host Disease in Patients Who Are Undergoing Donor Stem Cell Transplant for Hematologic Cancer
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
A Randomized Phase II Study to Determine the Most Promising Postgrafting Immunosuppression for Prevention of Acute GVHD After Unrelated Donor G-CSF Mobilized Peripheral Blood Mononuclear Cell G-PBMC Transplantation Using Nonmyeloablative Conditioning for Patients With Hematologic Malignancies A Multi-Center Trial
Status:
COMPLETED
Status Verified Date:
2019-10
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 randomized phase II trial studies how well giving tacrolimus and mycophenolate mofetil MMF with or without sirolimus works in preventing acute graft-versus-host disease GVHD in patients undergoing donor stem cell transplant for hematologic cancer Giving low doses of chemotherapy such as fludarabine phosphate and total-body-irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells It also stops 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 MMF and tacrolimus with or without sirolimus after transplant may stop this from happening
Detailed Description:
PRIMARY OBJECTIVES
I To determine which of 3 GVHD prophylaxis regimens results in reduction of acute grades II-IV GVHD to 40
SECONDARY OBJECTIVES
I Reduce the incidence of non-relapse mortality from infections and GVHD before day 200 to 15
II Reduce the utilization of high-dose corticosteroids compared to protocols 1463 1641 and 1668
III Compare survival and progression-free survival to that achieved under protocols 1463 1641 and 1668
OUTLINE
CONDITIONING All patients receive fludarabine phosphate intravenously IV over 30 minutes on days -4 to -2 and undergo total-body irradiation on day 0
TRANSPLANTATION All patients undergo allogeneic peripheral blood stem cell transplantation on day 0
IMMUNOSUPPRESSION Patients are randomized to 1 of 3 treatment arms
ARM I Patients receive tacrolimus IV or orally PO every 12 hours on days -3 to 180 with taper beginning on day 100 in the absence of GVHD Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-96 with taper beginning on day 40 in the absence of GVHD
ARM II Patients receive tacrolimus IV or PO every 12 hours on days -3 to 150 with taper beginning on day 100 in the absence of GVHD Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-180 with taper beginning on day 150 in the absence of GVHD
ARM III Patients receive tacrolimus and MMF as in arm II Patients also receive sirolimus PO once daily on days -3 to 80
After completion of study treatment patients are followed up at 6 months and then every year thereafter
I To determine which of 3 GVHD prophylaxis regimens results in reduction of acute grades II-IV GVHD to 40
SECONDARY OBJECTIVES
I Reduce the incidence of non-relapse mortality from infections and GVHD before day 200 to 15
II Reduce the utilization of high-dose corticosteroids compared to protocols 1463 1641 and 1668
III Compare survival and progression-free survival to that achieved under protocols 1463 1641 and 1668
OUTLINE
CONDITIONING All patients receive fludarabine phosphate intravenously IV over 30 minutes on days -4 to -2 and undergo total-body irradiation on day 0
TRANSPLANTATION All patients undergo allogeneic peripheral blood stem cell transplantation on day 0
IMMUNOSUPPRESSION Patients are randomized to 1 of 3 treatment arms
ARM I Patients receive tacrolimus IV or orally PO every 12 hours on days -3 to 180 with taper beginning on day 100 in the absence of GVHD Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-96 with taper beginning on day 40 in the absence of GVHD
ARM II Patients receive tacrolimus IV or PO every 12 hours on days -3 to 150 with taper beginning on day 100 in the absence of GVHD Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-180 with taper beginning on day 150 in the absence of GVHD
ARM III Patients receive tacrolimus and MMF as in arm II Patients also receive sirolimus PO once daily on days -3 to 80
After completion of study treatment patients are followed up at 6 months and then every year thereafter
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-2010-00268 | REGISTRY | None | None |
| 193800 | OTHER | None | None |
| P30CA015704 | NIH | None | None |