Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00049634
Status:
COMPLETED
Last Update Posted:
2010-09-16
First Post:
2002-11-12
Brief Title:
Donor Peripheral Stem Cell Transplant in Treating Patients With Myelodysplastic Syndrome Acute Myeloid Leukemia or Myeloproliferative Disorder
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
A Phase III Study of Immunologically Engineered rhG-CSF Mobilized Peripheral Blood Stem Cells PBSC for Allogeneic Transplant From HLA Identical Related Donors for Treatment of Myeloid Malignancies
Status:
COMPLETED
Status Verified Date:
2010-09
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 Giving chemotherapy drugs before a donor peripheral blood stem cell transplant helps stop the growth of cancer and abnormal cells and helps stop the patients immune system from rejecting the donors stem cells When the healthy stem cells from a donor are infused into the patient they may help the patients bone marrow make stem cells red blood cells white blood cells and platelets Giving colony-stimulating factors such as G-CSF to the donor helps the stem cells move from the bone marrow to the blood so they can be collected and stored
PURPOSE This phase III trial is studying how well donor peripheral stem cell transplant works in treating patients with myelodysplastic syndrome acute myeloid leukemia or myeloproliferative disorder
PURPOSE This phase III trial is studying how well donor peripheral stem cell transplant works in treating patients with myelodysplastic syndrome acute myeloid leukemia or myeloproliferative disorder
Detailed Description:
OBJECTIVES
Determine the incidence of grades II III and IV graft-vs-host disease GVHD in patients with myelodysplastic syndromes MDS acute myeloid leukemia transformed from MDS or myeloproliferative disorders treated with immunologically engineered filgrastim G-CSF-mobilized allogeneic peripheral blood stem cell transplantation
Determine the incidence of graft failure relapse and transplant-related mortality by day 100 in patients treated with this regimen
Determine the incidence of chronic GVHD in terms of number and duration of immunosuppressant therapies in patients treated with this regimen
Determine the feasibility of partial T-cell depletion in G-CSF-mobilized peripheral blood stem cells
OUTLINE Patients receive conditioning with oral busulfan every 6 hours on days -7 to -4 and cyclophosphamide IV on days -3 and -2 Immunologically engineered filgrastim G-CSF-mobilized allogeneic peripheral blood stem cells are infused on day 0
Patients receive graft-vs-host disease prophylaxis comprising methotrexate IV on days 1 3 6 and 11 and cyclosporine IV over 1-4 hours orally twice daily when tolerated on days -1 to 80 and then gradually tapered over 5 months beginning on day 81
Patients are followed regularly through day 100 and then at 1 year
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study within 3 years
Determine the incidence of grades II III and IV graft-vs-host disease GVHD in patients with myelodysplastic syndromes MDS acute myeloid leukemia transformed from MDS or myeloproliferative disorders treated with immunologically engineered filgrastim G-CSF-mobilized allogeneic peripheral blood stem cell transplantation
Determine the incidence of graft failure relapse and transplant-related mortality by day 100 in patients treated with this regimen
Determine the incidence of chronic GVHD in terms of number and duration of immunosuppressant therapies in patients treated with this regimen
Determine the feasibility of partial T-cell depletion in G-CSF-mobilized peripheral blood stem cells
OUTLINE Patients receive conditioning with oral busulfan every 6 hours on days -7 to -4 and cyclophosphamide IV on days -3 and -2 Immunologically engineered filgrastim G-CSF-mobilized allogeneic peripheral blood stem cells are infused on day 0
Patients receive graft-vs-host disease prophylaxis comprising methotrexate IV on days 1 3 6 and 11 and cyclosporine IV over 1-4 hours orally twice daily when tolerated on days -1 to 80 and then gradually tapered over 5 months beginning on day 81
Patients are followed regularly through day 100 and then at 1 year
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study within 3 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 |
|---|---|---|---|
| CDR0000258137 | REGISTRY | PDQ | None |
| FHCRC-162800 | None | None | None |
| NCI-H02-0099 | None | None | None |