Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00134004
Status:
COMPLETED
Last Update Posted:
2015-10-06
First Post:
2005-08-22
Brief Title:
Fludarabine Cyclophosphamide and Total-Body Irradiation in Treating Patients Who Are Undergoing a Donor Bone Marrow 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:
A Phase II Trial of Non-Myeloablative Conditioning and Transplantation of Partially HLA-Mismatched Bone Marrow for Patients With Hematologic Malignancies
Status:
COMPLETED
Status Verified Date:
2015-09
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 cyclophosphamide and radiation therapy before a donor bone marrow transplant helps stop the growth of cancer cells Giving chemotherapy or radiation therapy before or after transplant also stops the patients immune system from rejecting the donors bone marrow stem cells The donated stem cells may replace the patients immune system cells 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
PURPOSE This phase II trial is studying how well giving fludarabine and cyclophosphamide together with total-body irradiation works in treating patients who are undergoing a donor bone marrow transplant for hematologic cancer
PURPOSE This phase II trial is studying how well giving fludarabine and cyclophosphamide together with total-body irradiation works in treating patients who are undergoing a donor bone marrow transplant for hematologic cancer
Detailed Description:
OBJECTIVES
Determine transplant-related mortality risk of relapse and progression-free survival of patients with standard- or high-risk hematologic malignancies undergoing nonmyeloablative conditioning comprising fludarabine cyclophosphamide and total-body irradiation followed by HLA-haploidentical allogeneic bone marrow transplantation
Determine donor hematopoietic chimerism in patients peripheral blood at 30 60 and 180 days after transplantation
Determine hematologic and nonhematologic toxic effects of this regimen in these patients
Determine when feasible surface expression of HLA molecules and death receptors sensitivity to cytotoxic lymphocytes and expression of anti-apoptotic genes eg Bcl-2 Bcl-xL X-IAP and c-FLIP in cancer cells from patients who relapse after treatment with this regimen
OUTLINE This is a multicenter study Patients are stratified according to risk of relapse standard defined as 30 risk vs high defined as 70 risk
Nonmyeloablative conditioning regimen Patients receive fludarabine IV over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1-2 hours on days -6 and -5 Patients undergo total body irradiation on day -1
Allogeneic bone marrow transplantation Patients undergo donor bone marrow infusion on day 0
Post-transplantation therapy Patients receive cyclophosphamide IV over 1-2 hours on days 3 and 4
Graft-vs-host disease prophylaxis Beginning on day 5 patients receive oral mycophenolate mofetil 3 times daily until day 35 and tacrolimus IV then changing to orally twice daily until day 180
Treatment continues in the absence of disease progression
After completion of study transplantation patients are followed on days 30 60 100 and 180 at 1 year and then annually for 4 additional years
PROJECTED ACCRUAL A total of 75-100 patients will be accrued for this study within 3-4 years
Determine transplant-related mortality risk of relapse and progression-free survival of patients with standard- or high-risk hematologic malignancies undergoing nonmyeloablative conditioning comprising fludarabine cyclophosphamide and total-body irradiation followed by HLA-haploidentical allogeneic bone marrow transplantation
Determine donor hematopoietic chimerism in patients peripheral blood at 30 60 and 180 days after transplantation
Determine hematologic and nonhematologic toxic effects of this regimen in these patients
Determine when feasible surface expression of HLA molecules and death receptors sensitivity to cytotoxic lymphocytes and expression of anti-apoptotic genes eg Bcl-2 Bcl-xL X-IAP and c-FLIP in cancer cells from patients who relapse after treatment with this regimen
OUTLINE This is a multicenter study Patients are stratified according to risk of relapse standard defined as 30 risk vs high defined as 70 risk
Nonmyeloablative conditioning regimen Patients receive fludarabine IV over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1-2 hours on days -6 and -5 Patients undergo total body irradiation on day -1
Allogeneic bone marrow transplantation Patients undergo donor bone marrow infusion on day 0
Post-transplantation therapy Patients receive cyclophosphamide IV over 1-2 hours on days 3 and 4
Graft-vs-host disease prophylaxis Beginning on day 5 patients receive oral mycophenolate mofetil 3 times daily until day 35 and tacrolimus IV then changing to orally twice daily until day 180
Treatment continues in the absence of disease progression
After completion of study transplantation patients are followed on days 30 60 100 and 180 at 1 year and then annually for 4 additional years
PROJECTED ACCRUAL A total of 75-100 patients will be accrued for this study within 3-4 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 |
|---|---|---|---|
| JHOC-04072704 | Other Identifier | Johns Hopkins SKCCC | httpsreporternihgovquickSearchP30CA006973 |
| P01CA015396 | NIH | None | None |
| P30CA006973 | NIH | None | None |
| JHOC-J0457 | OTHER | None | None |