Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00048412
Status:
COMPLETED
Last Update Posted:
2020-01-18
First Post:
2002-10-30
Brief Title:
Stem Cell Transplant for Patients With Blood Malignancy Using Donors and Less Toxic Chemotherapy With CAMPATH 1H
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
Phase III Study of Allogeneic Stem Cell Transplantation for Patients With Hematologic Malignancy Using MHC Identical or Near Identical Donors and Sub-Myeloablative Conditioning With CAMPATH 1H DIMSUM
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
1 To assess the treatment related mortality of allogeneic stem cell transplantation with non-myeloablative therapy incorporating the lymphodepleting MAb CAMPATH-1H in patients with hematological diseases and renal cell carcinoma not eligible for conventional myeloablative therapy
2 To assess the time to engraftment and incidence of graft failure in patients receiving this transplant regimen
3 To assess the safety pharmacokinetics and immunologic activity of CAMPATH-1H when used as part of a subablative conditioning regimen
2 To assess the time to engraftment and incidence of graft failure in patients receiving this transplant regimen
3 To assess the safety pharmacokinetics and immunologic activity of CAMPATH-1H when used as part of a subablative conditioning regimen
Detailed Description:
This is a two arm study in which outcomes will be assessed independently in recipients of HLA matched sibling transplants and recipients of unrelated or mismatched family donor transplants although both groups will receive identical treatments
The following will be given to the patient after admission
Day - 6 Total body irradiation
Day - 5 to - 2 Fludarabine and Campath 1H
Day - 1 Day of rest
Day 0 Stem cell transplant infusion
The following will be given to the patient after admission
Day - 6 Total body irradiation
Day - 5 to - 2 Fludarabine and Campath 1H
Day - 1 Day of rest
Day 0 Stem cell transplant infusion
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 |
|---|---|---|---|
| DIMSUM | None | None | None |