Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00134017
Status:
COMPLETED
Last Update Posted:
2018-08-31
First Post:
2005-08-22
Brief Title:
Combination Chemotherapy Bone Marrow Transplant and Post Transplant Cyclophosphamide 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:
HLA Matched Related and Unrelated Bone Marrow Transplantation With BusulfanCyclophosphamide and Post Transplantation Cyclophosphamide for Hematological Malignancies
Status:
COMPLETED
Status Verified Date:
2018-08
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 chemotherapy before a donor bone marrow transplant helps stop the growth of cancer and abnormal cells and helps stop the patients immune system from rejecting the donors stem cells When the healthy stem cells from a donor are infused into the patient they may help the patients bone marrow make stem cells red blood cells white blood cells and platelets Sometimes the transplanted cells from a donor can make an immune response against the bodys normal cells Giving cyclophosphamide mycophenolate mofetil or tacrolimus after transplant may stop this from happening
PURPOSE This clinical trial is studying how well giving combination chemotherapy together with tacrolimus and mycophenolate mofetil works in treating patients who are undergoing a donor bone marrow transplant for hematologic cancer
PURPOSE This clinical trial is studying how well giving combination chemotherapy together with tacrolimus and mycophenolate mofetil works in treating patients who are undergoing a donor bone marrow transplant for hematologic cancer
Detailed Description:
OBJECTIVES
Primary
Determine the optimal dose of post-transplant immunosuppression comprising high-dose cyclophosphamide tacrolimus and mycophenolate mofetil administered after myeloablative conditioning chemotherapy comprising busulfan and cyclophosphamide followed by allogeneic bone marrow transplantation in patients with high-risk hematologic malignancies
Determine the incidence and severity of acute graft-versus-host disease in patients treated with this regimen
Determine other toxic effects of this regimen in these patients
Secondary
Determine immune reconstitution in patients treated with this regimen
Determine disease control in patients treated with this regimen
OUTLINE This is a pilot study Patients are stratified according to age 19 years old vs 19 years old
Myeloablative conditioning chemotherapy Patients receive busulfan IV or orally 4 times daily on days -7 to -4 OR days -6 to -3 and cyclophosphamide IV over 1 hour once daily on days -3 to -1 OR days -2 and -1
Allogeneic bone marrow transplantation Patients undergo allogeneic bone marrow transplantation on day 0
Immunosuppression therapy Patients receive high-dose cyclophosphamide IV over 1 hour on days 3 and 4
After completion of study transplantation patients are followed at 30 and 60 days 6 months 1 year and then annually thereafter
Primary
Determine the optimal dose of post-transplant immunosuppression comprising high-dose cyclophosphamide tacrolimus and mycophenolate mofetil administered after myeloablative conditioning chemotherapy comprising busulfan and cyclophosphamide followed by allogeneic bone marrow transplantation in patients with high-risk hematologic malignancies
Determine the incidence and severity of acute graft-versus-host disease in patients treated with this regimen
Determine other toxic effects of this regimen in these patients
Secondary
Determine immune reconstitution in patients treated with this regimen
Determine disease control in patients treated with this regimen
OUTLINE This is a pilot study Patients are stratified according to age 19 years old vs 19 years old
Myeloablative conditioning chemotherapy Patients receive busulfan IV or orally 4 times daily on days -7 to -4 OR days -6 to -3 and cyclophosphamide IV over 1 hour once daily on days -3 to -1 OR days -2 and -1
Allogeneic bone marrow transplantation Patients undergo allogeneic bone marrow transplantation on day 0
Immunosuppression therapy Patients receive high-dose cyclophosphamide IV over 1 hour on days 3 and 4
After completion of study transplantation patients are followed at 30 and 60 days 6 months 1 year and then annually 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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NA_00034100 | OTHER | JHMIRB | httpsreporternihgovquickSearchP30CA006973 |
| P01CA015396 | NIH | None | None |
| P30CA006973 | NIH | None | None |