Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005641
Status:
TERMINATED
Last Update Posted:
2012-12-11
First Post:
2000-05-02
Brief Title:
Removal of T Cells to Prevent Graft-Versus-Host Disease in Patients Undergoing Bone Marrow Transplantation
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
T-Cell Depletion for Graft-Versus-Host Disease GVHD Prevention in High Risk Matched and Mismatched Allogeneic Bone Marrow Transplantation
Status:
TERMINATED
Status Verified Date:
2012-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low study accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells Sometimes the transplanted cells from a donor can make an immune response against the bodys normal cells Eliminating the T cells from the donor cells before transplanting them may prevent this from happening
PURPOSE Phase II trial to study the effectiveness of T cell removal to prevent graft-versus-host disease in patients who are undergoing bone marrow transplantation from a donor
PURPOSE Phase II trial to study the effectiveness of T cell removal to prevent graft-versus-host disease in patients who are undergoing bone marrow transplantation from a donor
Detailed Description:
OBJECTIVES I Determine the incidence and severity of graft vs host disease GVHD following allogeneic bone marrow transplantation with marrow grafts modified by T cell depletion with counterflow centrifugal elutriation and CD34 cell selection in patients at high risk for GVHD II Determine the incidence of graft failure following this treatment regimen in this patient population III Determine the relapse rate and overall survival in this patient population treated with this regimen
OUTLINE Patients with unrelated donors mismatched related donors or matched related donors diagnosed with acute lymphocytic leukemia chronic lymphocytic leukemia myeloma or advanced acute myeloid leukemia AML receive cyclophosphamide IV over 60 minutes on days -6 and -5 and fractionated total body irradiation TBI 3 times a day on days -3 through -1 and twice on day 0 Patients receive graft vs host disease GVHD prophylaxis with anti-thymocyte globulin ATG IV over 8 hours on days -2 and -1 Patients undergo allogeneic bone marrow transplantation ABMT on day 0 with marrow grafts modified by T cell depletion with counterflow centrifugal elutriation and CD34 selection Patients unable to receive TBI due to matched or mismatched related donors or age 56 to 60 or patients diagnosed with AML-CR1 chronic myelogenous leukemia myelodysplastic syndrome or myeloproliferative disorders with matched related donors receive oral busulfan every 6 hours on days -7 through -4 cyclophosphamide IV over 60 minutes on days -3 and -2 and ATG IV over 8 hours on days -2 and -1 for GVHD prophylaxis Patients undergo T cell depleted ABMT on day 0 At pretransplantation patients with acute leukemia receive intrathecal IT methotrexate MTX following lumbar puncture At 48 hours following IT MTX patients with CNS involvement receive a second dose of IT MTX followed by oral leucovorin calcium every 6 hours for 4 doses Patients with prior CNS involvement receive cranial radiotherapy for 2 weeks Following AMBT patients undergo GVHD prophylaxis consisting of methylprednisolone IV every 12 hours on days 5-22 and then once daily on days 23-28 and cyclosporine IV or orally twice daily beginning on day -1 and continuing until 7-9 months following ABMT Patients are followed every 3 months until death
PROJECTED ACCRUAL Approximately 40 patients will be accrued for this study
OUTLINE Patients with unrelated donors mismatched related donors or matched related donors diagnosed with acute lymphocytic leukemia chronic lymphocytic leukemia myeloma or advanced acute myeloid leukemia AML receive cyclophosphamide IV over 60 minutes on days -6 and -5 and fractionated total body irradiation TBI 3 times a day on days -3 through -1 and twice on day 0 Patients receive graft vs host disease GVHD prophylaxis with anti-thymocyte globulin ATG IV over 8 hours on days -2 and -1 Patients undergo allogeneic bone marrow transplantation ABMT on day 0 with marrow grafts modified by T cell depletion with counterflow centrifugal elutriation and CD34 selection Patients unable to receive TBI due to matched or mismatched related donors or age 56 to 60 or patients diagnosed with AML-CR1 chronic myelogenous leukemia myelodysplastic syndrome or myeloproliferative disorders with matched related donors receive oral busulfan every 6 hours on days -7 through -4 cyclophosphamide IV over 60 minutes on days -3 and -2 and ATG IV over 8 hours on days -2 and -1 for GVHD prophylaxis Patients undergo T cell depleted ABMT on day 0 At pretransplantation patients with acute leukemia receive intrathecal IT methotrexate MTX following lumbar puncture At 48 hours following IT MTX patients with CNS involvement receive a second dose of IT MTX followed by oral leucovorin calcium every 6 hours for 4 doses Patients with prior CNS involvement receive cranial radiotherapy for 2 weeks Following AMBT patients undergo GVHD prophylaxis consisting of methylprednisolone IV every 12 hours on days 5-22 and then once daily on days 23-28 and cyclosporine IV or orally twice daily beginning on day -1 and continuing until 7-9 months following ABMT Patients are followed every 3 months until death
PROJECTED ACCRUAL Approximately 40 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 |
|---|---|---|---|
| BB-IDE-7181 | OTHER | FDA | None |
| MCC-11587 | None | None | None |
| MCC-IRB-4599 | None | None | None |
| NCI-G00-1781 | None | None | None |