Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00176839
Status:
TERMINATED
Last Update Posted:
2017-12-05
First Post:
2005-09-12
Brief Title:
Stem Cell Transplantation for Hematological Malignancies
Sponsor:
Masonic Cancer Center University of Minnesota
Organization:
Masonic Cancer Center University of Minnesota
Study Overview
Official Title:
Busulfan Cyclophosphamide and Melphalan Followed by Allogeneic Hematopoietic Cell Transplantation in Patients With Hematological Malignancies
Status:
TERMINATED
Status Verified Date:
2017-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Replaced by a different study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This protocol using busulfan cyclophosphamide and melphalan has been designed as conditioning therapy for patients receiving stem cell transplantation for acute leukemia or myelodysplastic syndrome MDS The hypothesis is that this new regimen will be well tolerated and will cure the patient
Detailed Description:
Subjects will be admitted to the bone marrow transplant unit and put in isolation to reduce exposure to infectious agents
Prior to transplantation they will receive BUSULFAN via the central venous line four times a day for four days CYCLOPHOSPHAMIDE via the central venous line once a day for two days and MELPHALAN via the central venous line for one day Busulfan cyclophosphamide and melphalan are given to destroy the subjects cancer As well these drugs will destroy their immune system to help ensure the new stem cells take and grow after transplantation
On the day of transplantation umbilical cord blood from the donor will be transfused via venous line These new cells will replace the subjects bone marrow
After transplantation the subjects will receive Cyclosporin A and either MMF or MTX
Isolation will be continued until adequate numbers of cells are present in the blood to fight infection Subjects will be discharged from the hospital when medically ready They will be expected to return for follow-up to the blood and marrow transplant clinic at specific dates as determined by physicians
Prior to transplantation they will receive BUSULFAN via the central venous line four times a day for four days CYCLOPHOSPHAMIDE via the central venous line once a day for two days and MELPHALAN via the central venous line for one day Busulfan cyclophosphamide and melphalan are given to destroy the subjects cancer As well these drugs will destroy their immune system to help ensure the new stem cells take and grow after transplantation
On the day of transplantation umbilical cord blood from the donor will be transfused via venous line These new cells will replace the subjects bone marrow
After transplantation the subjects will receive Cyclosporin A and either MMF or MTX
Isolation will be continued until adequate numbers of cells are present in the blood to fight infection Subjects will be discharged from the hospital when medically ready They will be expected to return for follow-up to the blood and marrow transplant clinic at specific dates as determined by physicians
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 |
|---|---|---|---|
| 0005M52481 | OTHER | Institutional Review Board University of Minnesota | None |
| MT2000-12 | OTHER | None | None |