Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003398
Status:
COMPLETED
Last Update Posted:
2019-10-17
First Post:
1999-11-01
Brief Title:
Bone Marrow Transplantation in Treating Patients With Hematologic Cancer
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Evaluation of Allogeneic Marrow Transplants Depleted of T-Cells by CD34 Selection in Patients Undergoing Transplantation With an Unrelated Matched or 1 Antigen Mismatched Donor or a 1 Antigen Mismatched Related Donor
Status:
COMPLETED
Status Verified Date:
2019-10
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 Bone marrow that has been treated to remove certain white blood cells may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy and may reduce the chance of developing graft-versus-host disease following bone marrow transplantation
PURPOSE Phase IV trial to study the incidence of graft-versus-host disease in patients who have hematologic cancer and who are undergoing bone marrow transplantation from a donor
PURPOSE Phase IV trial to study the incidence of graft-versus-host disease in patients who have hematologic cancer and who are undergoing bone marrow transplantation from a donor
Detailed Description:
OBJECTIVES I Evaluate the incidence of acute graft versus host disease in patients undergoing transplantation with an unrelated or related matched or mismatched antigen donor II Evaluate the rapidity of engraftment and CD4 count recovery post-transplantation in this patient population
OUTLINE Patients receive total body irradiation TBI three or two times a day on days -8 to -5 Following TBI patients receive thiotepa IV over 4 hours daily on days -4 and -3 plus cyclophosphamide IV over 1 hour daily on days -2 and -1 Antithymocyte globulin is administered by IV over at least 4 hours on days -4 to -1 Patients undergo an allogenic bone marrow transplantation on day 0 Bone marrow is harvested from patients donor depleted of T-cells and infused Patients receive filgrastim G-CSF subcutaneously beginning on day 4
PROJECTED ACCRUAL Approximately 26-45 patients will be accrued for this study within 3-4 years
OUTLINE Patients receive total body irradiation TBI three or two times a day on days -8 to -5 Following TBI patients receive thiotepa IV over 4 hours daily on days -4 and -3 plus cyclophosphamide IV over 1 hour daily on days -2 and -1 Antithymocyte globulin is administered by IV over at least 4 hours on days -4 to -1 Patients undergo an allogenic bone marrow transplantation on day 0 Bone marrow is harvested from patients donor depleted of T-cells and infused Patients receive filgrastim G-CSF subcutaneously beginning on day 4
PROJECTED ACCRUAL Approximately 26-45 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 |
|---|---|---|---|
| NCI-V98-1433 | None | None | None |
| MSGCC-9739 | None | None | None |