Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00089011
Status:
COMPLETED
Last Update Posted:
2020-01-29
First Post:
2004-08-04
Brief Title:
Tacrolimus and Mycophenolate Mofetil in Preventing Graft-Versus-Host Disease in Patients Who Have Undergone Total-Body Irradiation With or Without Fludarabine Phosphate Followed by Donor Peripheral Blood Stem Cell Transplant for Hematologic Cancer
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
A Multi-Center Study of Nonmyeloablative Conditioning With TBI or FludarabineTBI for HLA-matched Related Hematopoietic Cell Transplantation for Treatment of Hematologic Malignancies With Post Grafting Immunosuppression With Tacrolimus and Mycophenolate Mofetil
Status:
COMPLETED
Status Verified Date:
2019-12
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 II trial studies how well tacrolimus and mycophenolate mofetil works in preventing graft-versus-host disease in patients who have undergone total-body irradiation TBI with or without fludarabine phosphate followed by donor peripheral blood stem cell transplant for hematologic cancer Giving low doses of chemotherapy such as fludarabine phosphate and TBI 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 tacrolimus and mycophenolate mofetil after the transplant may stop this from happening
Detailed Description:
PRIMARY OBJECTIVES
I To estimate the incidence of grade IIIIV graft-versus-host disease GVHD after conditioning with 200 centigray cGy TBI alone or Fludarabine fludarabine phosphate200 cGy TBI followed by tacrolimus Tacmycophenolate mofetil MMF immunosuppression in patients with hematologic malignancies
II To estimate the incidence of chronic extensive GVHD
SECONDARY OBJECTIVES
I To estimate the incidences of graft rejection
II To estimate overall survival 1-year after conditioning
III To evaluate the incidences of grades II-IV acute GVHD
IV To evaluate the rates of disease progression andor relapse-related mortality
V To estimate the rate and duration of steroid use for the treatment of chronic GVHD
OUTLINE Patients are assigned to 1 of 2 treatment arms
ARM I nonmyeloablative conditioning with fludarabine phosphate and TBI Patients receive fludarabine phosphate intravenously IV on days -4 to -2 and undergo TBI on day 0
ARM II nonmyeloablative conditioning with TBI Patients undergo TBI on day 0
All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus orally PO every 12 hours on days -3 to 180 with taper on day 56 or tacrolimus IV if unable to tolerate PO and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO
Treatment continues in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 6 months for 2 years and then annually for 3 years
I To estimate the incidence of grade IIIIV graft-versus-host disease GVHD after conditioning with 200 centigray cGy TBI alone or Fludarabine fludarabine phosphate200 cGy TBI followed by tacrolimus Tacmycophenolate mofetil MMF immunosuppression in patients with hematologic malignancies
II To estimate the incidence of chronic extensive GVHD
SECONDARY OBJECTIVES
I To estimate the incidences of graft rejection
II To estimate overall survival 1-year after conditioning
III To evaluate the incidences of grades II-IV acute GVHD
IV To evaluate the rates of disease progression andor relapse-related mortality
V To estimate the rate and duration of steroid use for the treatment of chronic GVHD
OUTLINE Patients are assigned to 1 of 2 treatment arms
ARM I nonmyeloablative conditioning with fludarabine phosphate and TBI Patients receive fludarabine phosphate intravenously IV on days -4 to -2 and undergo TBI on day 0
ARM II nonmyeloablative conditioning with TBI Patients undergo TBI on day 0
All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus orally PO every 12 hours on days -3 to 180 with taper on day 56 or tacrolimus IV if unable to tolerate PO and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO
Treatment continues in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 6 months for 2 years and then annually for 3 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 |
|---|---|---|---|
| P30CA015704 | NIH | Fred Hutchinson Cancer Research CenterUniversity of Washington Cancer Consortium | httpsreporternihgovquickSearchP30CA015704 |
| NCI-2010-00267 | REGISTRY | None | None |
| 189800 | OTHER | None | None |
| P01CA078902 | NIH | None | None |