Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002790
Status:
WITHDRAWN
Last Update Posted:
2015-03-06
First Post:
1999-11-01
Brief Title:
Prevention of Graft-Versus-Host Disease in Patients With Hematologic Malignancies Who Are Receiving a Bone Marrow Transplant
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
A PHASE III STUDY OF RAPAMYCIN SIROLIMUS IN COMBINATION WITH METHOTREXATE MTX AND CYCLOSPORINE CPS IN PATIENTS UNDERGOING MARROW TRANSPLANTATION FROM RELATED DONORS MISMATCHED FOR ONE HLA ANTIGEN IN THE DIRECTION OF GRAFT-VERSUS-HOST DISEASE GVHD
Status:
WITHDRAWN
Status Verified Date:
2015-03
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 Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells Sometimes the transplanted cells can make an immune response against the bodys normal tissues Treatment with sirolimus methotrexate and cyclosporine may prevent this from happening
PURPOSE Phase III trial to study the effectiveness of sirolimus plus methotrexate and cyclosporine in preventing graft-versus-host disease in patients with hematologic malignancies who are receiving a bone marrow transplant
PURPOSE Phase III trial to study the effectiveness of sirolimus plus methotrexate and cyclosporine in preventing graft-versus-host disease in patients with hematologic malignancies who are receiving a bone marrow transplant
Detailed Description:
OBJECTIVES I Estimate the maximum tolerated dose of rapamycin that can be safely combined with standard methotrexatecyclosporine prophylaxis for graft-versus-host disease GVHD in patients with hematologic disorders who have received a bone marrow transplant from a related donor who is mismatched for 1 HLA-A -B or -DR antigen in the GVHD direction
OUTLINE This is a dose escalation study Groups of 6-12 patients receive escalating doses of rapamycin until the maximum tolerated dose of rapamycin given in combination with methotrexatecyclosporine is determined All patients receive cyclosporine from the day prior to transplant until day 50 post-transplant the dose is then tapered over 130 days Methotrexate is given on days 1 3 and 6 post-transplant Rapamycin is given every other day days 7-59 Bone marrow transplantation occurs on day 0 Patients may not receive concurrent therapy with agents that could interfere with rapamycin metabolism intravenous lipids FK506 or other immunosuppressive agents prednisone allowed NSAIDs or other cytotoxic agents Patients are followed at 6 months for 2 years then annually
PROJECTED ACCRUAL 12-36 patients will be accrued over 1-25 years
OUTLINE This is a dose escalation study Groups of 6-12 patients receive escalating doses of rapamycin until the maximum tolerated dose of rapamycin given in combination with methotrexatecyclosporine is determined All patients receive cyclosporine from the day prior to transplant until day 50 post-transplant the dose is then tapered over 130 days Methotrexate is given on days 1 3 and 6 post-transplant Rapamycin is given every other day days 7-59 Bone marrow transplantation occurs on day 0 Patients may not receive concurrent therapy with agents that could interfere with rapamycin metabolism intravenous lipids FK506 or other immunosuppressive agents prednisone allowed NSAIDs or other cytotoxic agents Patients are followed at 6 months for 2 years then annually
PROJECTED ACCRUAL 12-36 patients will be accrued over 1-25 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 |
|---|---|---|---|
| CDR0000064855 | REGISTRY | PDQ | None |
| FHCRC-109600 | None | None | None |
| NCI-H96-0928 | None | None | None |