Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006042
Status:
COMPLETED
Last Update Posted:
2010-03-10
First Post:
2000-07-05
Brief Title:
Cyclophosphamide Plus Bone Marrow Transplantation in Treating Patients With Hematologic Cancer
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
Non-Myeloablative Allogeneic Bone Marrow Transplantation for Hematologic Malignancies Using Haploidentical Donors A Phase I Trial of Pre-Transplant Cyclophosphamide
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 Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill cancer cells
PURPOSE Phase I trial to study the effectiveness of cyclophosphamide plus bone marrow transplantation in treating patients who have hematologic cancer
PURPOSE Phase I trial to study the effectiveness of cyclophosphamide plus bone marrow transplantation in treating patients who have hematologic cancer
Detailed Description:
OBJECTIVES
Determine the minimum effective dose of pretransplant cyclophosphamide to induce engraftment of haploidentical allogeneic bone marrow without the use of myeloablative conditioning in patients with hematologic malignancies
Determine the incidence and severity of graft versus host disease and nonhematologic toxicities with this treatment regimen in these patients
Correlate the pretreatment phenotypic and functional immunologic characteristics in these patients in relation to risk of graft rejection with this treatment regimen
OUTLINE This is a dose-escalation study of cyclophosphamide
Patients receive fludarabine IV over 1 hour on days -6 to -2 cyclophosphamide IV over 1 hour on days -6 -5 and 3 total body irradiation on day -1 and allogeneic bone marrow transplantation on day 0 Patients also receive tacrolimus IV or orally twice a day on days 4-50 oral mycophenolate mofetil on days 4-35 and filgrastim G-CSF subcutaneously or IV starting on day 4 and continuing until blood counts recover
Cohorts of 3-6 patients receive escalating doses of cyclophosphamide until the minimum effective dose necessary to induce chimerism without unacceptable toxicity in these patients is determined
Patients are followed at 2 and 6 months at one year and then annually thereafter
PROJECTED ACCRUAL At least 23 patients will be accrued for this study
Determine the minimum effective dose of pretransplant cyclophosphamide to induce engraftment of haploidentical allogeneic bone marrow without the use of myeloablative conditioning in patients with hematologic malignancies
Determine the incidence and severity of graft versus host disease and nonhematologic toxicities with this treatment regimen in these patients
Correlate the pretreatment phenotypic and functional immunologic characteristics in these patients in relation to risk of graft rejection with this treatment regimen
OUTLINE This is a dose-escalation study of cyclophosphamide
Patients receive fludarabine IV over 1 hour on days -6 to -2 cyclophosphamide IV over 1 hour on days -6 -5 and 3 total body irradiation on day -1 and allogeneic bone marrow transplantation on day 0 Patients also receive tacrolimus IV or orally twice a day on days 4-50 oral mycophenolate mofetil on days 4-35 and filgrastim G-CSF subcutaneously or IV starting on day 4 and continuing until blood counts recover
Cohorts of 3-6 patients receive escalating doses of cyclophosphamide until the minimum effective dose necessary to induce chimerism without unacceptable toxicity in these patients is determined
Patients are followed at 2 and 6 months at one year and then annually thereafter
PROJECTED ACCRUAL At least 23 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 |
|---|---|---|---|
| P30CA006973 | NIH | None | None |
| JHOC-J9966 | None | None | None |
| JHOC-99110501 | None | None | None |
| NCI-G00-1816 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA006973 |