Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00255710
Status:
COMPLETED
Last Update Posted:
2010-03-17
First Post:
2005-11-18
Brief Title:
Cyclophosphamide andor Mycophenolate Mofetil With or Without Tacrolimus in Treating Patients Who Are Undergoing a Donor Bone Marrow or Peripheral Stem Cell Transplant for Hematologic Cancer
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
Nonmyeloablative Bone Marrow Transplants in Hematologic Malignancies Dose Finding Study for Post-Transplant Immunosuppression
Status:
COMPLETED
Status Verified Date:
2010-03
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 Giving low doses of chemotherapy such as fludarabine and radiation therapy before a donor bone marrow or 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 cyclophosphamide mycophenolate mofetil and tacrolimus after transplant may stop this from happening
PURPOSE This phase I trial is studying cyclophosphamide andor mycophenolate mofetil with or without tacrolimus to see which is the best regimen in treating patients who are undergoing a donor bone marrow or stem cell transplant for hematologic cancer
PURPOSE This phase I trial is studying cyclophosphamide andor mycophenolate mofetil with or without tacrolimus to see which is the best regimen in treating patients who are undergoing a donor bone marrow or stem cell transplant for hematologic cancer
Detailed Description:
OBJECTIVES
Determine a minimal short-duration post-transplant immunosuppression regimen comprising cyclophosphamide andor mycophenolate mofetil with or without tacrolimus that results in 20 incidence of grade II or higher acute graft-versus-host disease GVHD in patients with hematologic malignancies undergoing nonmyeloablative allogeneic bone marrow or peripheral blood stem cell transplantation from an HLA-identical related donor
Determine the post-transplant immunosuppression regimen that results in 10 incidence of nonengraftment defined as 5 donor chimerism in peripheral blood at day 60 in these patients
Determine the incidence and severity of acute GVHD in patients treated with these regimens
Determine the frequency of mixed chimerism in patients treated with these regimens
OUTLINE
Nonmyeloablative allogeneic bone marrow transplantation BMT or peripheral blood stem cell transplantation PBSCT Patients receive fludarabine IV on days -4 to -2 and undergo total-body irradiation on day -1 Patients undergo allogeneic BMT on day 0 or PBSCT on day 0 and days 1 and 2 if needed Patients receive filgrastim G-CSF beginning on day 5 and continuing until at least day 15 or until blood counts recover
Sequentially increasing levels of post-transplant immunosuppression Cohorts of patients are enrolled into 1 of the following regimens
Regimen 1 post-BMT immunosuppression Patients receive cyclophosphamide IV on day 3 only
Regimen 2 post-BMT immunosuppression Patients receive mycophenolate mofetil MMF once on day 3 and then twice daily on days 4-32
Regimen 3 post-BMT immunosuppression Patients receive cyclophosphamide IV on days 3 and 4 and MMF twice daily on days 4-33
Regimen 4 post-PBSCT immunosuppression Patients receive cyclophosphamide and MMF as in regimen 3
Regimen 5 post-PBSCT immunosuppression Patients receive cyclophosphamide and MMF as in regimen 3 and tacrolimus twice daily on days 4-33
Cohorts of approximately 10-20 patients receive sequentially increasing levels of post-transplant immunosuppression until a minimal short-duration post-transplant immunosuppression regimen is identified The minimal post-transplant immunosuppression regimen is defined as the regimen in which 3 of 10 or 6 of 20 patients develop grade II or higher acute graft-versus-host disease AND 2 of 10 or 4 of 20 patients fail to engraft 60 days post-transplantation Once the minimal post-transplant immunosuppression regimen is identified an additional 10 patients are treated with that regimen
Patients are followed for 60 days after transplantation
PROJECTED ACCRUAL A total of 60 patients will be accrued for this study
Determine a minimal short-duration post-transplant immunosuppression regimen comprising cyclophosphamide andor mycophenolate mofetil with or without tacrolimus that results in 20 incidence of grade II or higher acute graft-versus-host disease GVHD in patients with hematologic malignancies undergoing nonmyeloablative allogeneic bone marrow or peripheral blood stem cell transplantation from an HLA-identical related donor
Determine the post-transplant immunosuppression regimen that results in 10 incidence of nonengraftment defined as 5 donor chimerism in peripheral blood at day 60 in these patients
Determine the incidence and severity of acute GVHD in patients treated with these regimens
Determine the frequency of mixed chimerism in patients treated with these regimens
OUTLINE
Nonmyeloablative allogeneic bone marrow transplantation BMT or peripheral blood stem cell transplantation PBSCT Patients receive fludarabine IV on days -4 to -2 and undergo total-body irradiation on day -1 Patients undergo allogeneic BMT on day 0 or PBSCT on day 0 and days 1 and 2 if needed Patients receive filgrastim G-CSF beginning on day 5 and continuing until at least day 15 or until blood counts recover
Sequentially increasing levels of post-transplant immunosuppression Cohorts of patients are enrolled into 1 of the following regimens
Regimen 1 post-BMT immunosuppression Patients receive cyclophosphamide IV on day 3 only
Regimen 2 post-BMT immunosuppression Patients receive mycophenolate mofetil MMF once on day 3 and then twice daily on days 4-32
Regimen 3 post-BMT immunosuppression Patients receive cyclophosphamide IV on days 3 and 4 and MMF twice daily on days 4-33
Regimen 4 post-PBSCT immunosuppression Patients receive cyclophosphamide and MMF as in regimen 3
Regimen 5 post-PBSCT immunosuppression Patients receive cyclophosphamide and MMF as in regimen 3 and tacrolimus twice daily on days 4-33
Cohorts of approximately 10-20 patients receive sequentially increasing levels of post-transplant immunosuppression until a minimal short-duration post-transplant immunosuppression regimen is identified The minimal post-transplant immunosuppression regimen is defined as the regimen in which 3 of 10 or 6 of 20 patients develop grade II or higher acute graft-versus-host disease AND 2 of 10 or 4 of 20 patients fail to engraft 60 days post-transplantation Once the minimal post-transplant immunosuppression regimen is identified an additional 10 patients are treated with that regimen
Patients are followed for 60 days after transplantation
PROJECTED ACCRUAL A total of 60 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 |
|---|---|---|---|
| WIRB-20020304 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA006973 |
| P01CA015396 | NIH | None | None |
| P30CA006973 | NIH | None | None |
| JHOC-J0169 | None | None | None |