Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005852
Status:
TERMINATED
Last Update Posted:
2012-12-11
First Post:
2000-06-02
Brief Title:
Bone Marrow Transplantation in Treating Patients With Severe Aplastic Anemia or Rejection of Previous Bone Marrow Transplant
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
Allogeneic Bone Marrow Transplantation for Marrow Failure States
Status:
TERMINATED
Status Verified Date:
2012-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low 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 from donors may be able to treat patients with severe aplastic anemia and patients whose bodies have rejected previous bone marrow transplantation
PURPOSE Phase II trial to study the effectiveness of bone marrow transplantation in treating patients who have severe aplastic anemia or whose bodies have rejected previous bone marrow transplant
PURPOSE Phase II trial to study the effectiveness of bone marrow transplantation in treating patients who have severe aplastic anemia or whose bodies have rejected previous bone marrow transplant
Detailed Description:
OBJECTIVES I Determine the graft failure rate and overall survival of patients with severe aplastic anemia after receiving an allogeneic bone marrow transplant II Determine the efficacy of high dose cyclophosphamide and antithymocyte globulin as conditioning regimen for a second bone marrow transplant in patients who reject their first graft III Determine the efficacy of methylprednisolone and anti-CD3 monoclonal antibody as a conditioning regimen for a second bone marrow transplant in patients who reject their first graft and are poor candidates for cyclophosphamide and antithymocyte globulin
OUTLINE Patients with graft failure with the following organ function and performance status are assigned to arm I Performance status Karnofsky 60-100 Pulmonary FEV1 and DLCO at least 50 Cardiac Left ventricular ejection fraction at least 45 Hepatic None to mild venoocclusive disease Patients with graft failure with the following organ function and performance status are assigned to arm II Performance status Karnofsky 20-50 Pulmonary FEV1 or DLCO less than 50 Cardiac Left ventricular ejection fraction less than 45 Hepatic Moderate to severe venoocclusive disease Patients with aplastic anemia are assigned to arm I Arm I Patients receive cyclophosphamide IV over 1 hour on days -5 to -2 antithymocyte globulin IV over 8 hours on days -5 to -3 and bone marrow transplant on day 0 Arm II Patients receive methylprednisolone IV twice a day on days -5 to 62 monoclonal antibody OKT3 IV on days -1 to 24 bone marrow transplant on day 0 oral cyclosporine twice a day starting day 20 and filgrastim G-CSF subcutaneously once a day starting day -5 until blood counts recover Patients are followed once a week for 3 months and then monthly for one year
PROJECTED ACCRUAL A total of 40 patients 20 with aplastic anemia and 20 with graft failure will be accrued for this study
OUTLINE Patients with graft failure with the following organ function and performance status are assigned to arm I Performance status Karnofsky 60-100 Pulmonary FEV1 and DLCO at least 50 Cardiac Left ventricular ejection fraction at least 45 Hepatic None to mild venoocclusive disease Patients with graft failure with the following organ function and performance status are assigned to arm II Performance status Karnofsky 20-50 Pulmonary FEV1 or DLCO less than 50 Cardiac Left ventricular ejection fraction less than 45 Hepatic Moderate to severe venoocclusive disease Patients with aplastic anemia are assigned to arm I Arm I Patients receive cyclophosphamide IV over 1 hour on days -5 to -2 antithymocyte globulin IV over 8 hours on days -5 to -3 and bone marrow transplant on day 0 Arm II Patients receive methylprednisolone IV twice a day on days -5 to 62 monoclonal antibody OKT3 IV on days -1 to 24 bone marrow transplant on day 0 oral cyclosporine twice a day starting day 20 and filgrastim G-CSF subcutaneously once a day starting day -5 until blood counts recover Patients are followed once a week for 3 months and then monthly for one year
PROJECTED ACCRUAL A total of 40 patients 20 with aplastic anemia and 20 with graft failure 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 |
|---|---|---|---|
| NCI-G00-1791 | None | None | None |
| MCC-11309 | None | None | None |
| MCC-IRB-4251 | None | None | None |