Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00167219
Status:
COMPLETED
Last Update Posted:
2023-11-07
First Post:
2005-09-09
Brief Title:
Stem Cell Transplant for Juvenile Myelomonocytic Leukemia JMML
Sponsor:
Masonic Cancer Center University of Minnesota
Organization:
Masonic Cancer Center University of Minnesota
Study Overview
Official Title:
Hematopoietic Cell Transplantation in Children With Juvenile Myelomonocytic Leukemia
Status:
COMPLETED
Status Verified Date:
2023-11
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:
The investigators hypothesize that long-term disease-free survival DFS in patients with JMML can be achieved with a treatment of busulfan BU cyclophosphamide CY and melphalan L-PAM followed by hematopoietic cell transplantation HCT
Detailed Description:
Prior to transplantation subjects will receive BUSULFAN via the central venous line six 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 leukemia As well these drugs will destroy the subjects own immune system to help ensure the new bone marrow takes and grows after transplantation
On the day of transplantation bone marrow or umbilical cord blood from the donor will arrive to the bone marrow transplant unit and be transfused via venous line These new cells will replace the subjects bone marrow
On the day of transplantation bone marrow or umbilical cord blood from the donor will arrive to the bone marrow transplant unit and be transfused via venous line These new cells will replace the subjects bone marrow
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MT1999-20 | OTHER | None | None |
| 9911M24961 | OTHER | IRB University of Minnesota | None |