Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00322101
Status:
COMPLETED
Last Update Posted:
2014-10-31
First Post:
2006-05-02
Brief Title:
Low-Dose or High-Dose Conditioning Followed by Peripheral Blood Stem Cell Transplant in Treating Patients With Myelodysplastic Syndrome or Acute Myelogenous Leukemia
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
A Multi-center Phase III Study Comparing Myeloablative to Nonmyeloablative Transplant Conditioning in Patients With Myelodysplastic Syndrome or Acute Myelogenous Leukemia
Status:
COMPLETED
Status Verified Date:
2014-10
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 Giving chemotherapy such as fludarabine phosphate busulfan and cyclophosphamide and total-body radiation therapy before a donor peripheral stem cell transplant helps stop the growth of cancer cells It may also 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 It is not yet known whether low-dose chemotherapy and total-body radiation therapy is more effective than high-dose chemotherapy in treating patients with myelodysplastic syndrome or acute myeloid leukemia
PURPOSE This phase III trial is studying low-dose conditioning to see how well it works compared to high-dose conditioning followed by peripheral blood stem cell transplant in treating patients with myelodysplastic syndromes or acute myeloid leukemia
PURPOSE This phase III trial is studying low-dose conditioning to see how well it works compared to high-dose conditioning followed by peripheral blood stem cell transplant in treating patients with myelodysplastic syndromes or acute myeloid leukemia
Detailed Description:
OBJECTIVES
I Determine whether the conditioning intensity affects outcomes after HCT in patients with MDS or AML who have 5 marrow myeloblasts at the time of HCT
OUTLINE Patients are randomized to 1 of 2 treatment arms
Arm I Nonmyeloablative regimen
CONDITIONING Patients receive fludarabine phosphate IV on days -4 to -2 and undergo low-dose total-body irradiation on day 0
TRANSPLANTATION Patients undergo allogeneic peripheral blood stem cell PBSC infusion on day 0
GRAFT-VS-HOST DISEASE PROPHYLAXIS Patients receive cyclosporine every 12 hours on days -3 to 57 with taper on days 57-177 or cyclosporine every 12 hours on days -3 to 100 with taper on days 101-177 Patients also receive oral mycophenolate mofetil every 12 hours on days 0-27 or every 8 hours on days 0-40 with taper on days 41-96
Arm II Myeloablative regimen
CONDITIONING Patients are assigned to 1 of 2 treatment groups
Group A Patients receive fludarabine IV once daily and oral busulfan four times daily or busulfan IV over 3 hours on days -5 to -2
Group B Patients receive cyclophosphamide IV over 1-2 hours on days -3 and -2 and oral busulfan four times daily or busulfan IV over 3 hours on days -7 to -4
TRANSPLANTATION Patients undergo PBSC infusion on day 0
GRAFT-VS-HOST DISEASE PROPHYLAXIS Patients receive tacrolimus IV continuously or orally every 12 hours on days -1 to 56 and taper on days 57-200 Patients also receive methotrexate IV on days 1 3 6 and 11
Treatment in both arms continues in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up periodically
I Determine whether the conditioning intensity affects outcomes after HCT in patients with MDS or AML who have 5 marrow myeloblasts at the time of HCT
OUTLINE Patients are randomized to 1 of 2 treatment arms
Arm I Nonmyeloablative regimen
CONDITIONING Patients receive fludarabine phosphate IV on days -4 to -2 and undergo low-dose total-body irradiation on day 0
TRANSPLANTATION Patients undergo allogeneic peripheral blood stem cell PBSC infusion on day 0
GRAFT-VS-HOST DISEASE PROPHYLAXIS Patients receive cyclosporine every 12 hours on days -3 to 57 with taper on days 57-177 or cyclosporine every 12 hours on days -3 to 100 with taper on days 101-177 Patients also receive oral mycophenolate mofetil every 12 hours on days 0-27 or every 8 hours on days 0-40 with taper on days 41-96
Arm II Myeloablative regimen
CONDITIONING Patients are assigned to 1 of 2 treatment groups
Group A Patients receive fludarabine IV once daily and oral busulfan four times daily or busulfan IV over 3 hours on days -5 to -2
Group B Patients receive cyclophosphamide IV over 1-2 hours on days -3 and -2 and oral busulfan four times daily or busulfan IV over 3 hours on days -7 to -4
TRANSPLANTATION Patients undergo PBSC infusion on day 0
GRAFT-VS-HOST DISEASE PROPHYLAXIS Patients receive tacrolimus IV continuously or orally every 12 hours on days -1 to 56 and taper on days 57-200 Patients also receive methotrexate IV on days 1 3 6 and 11
Treatment in both arms continues in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up periodically
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 |
|---|---|---|---|
| P01HL036444 | NIH | CTRP Clinical Trial Reporting Program | httpsreporternihgovquickSearchP01HL036444 |
| NCI-2010-00737 | REGISTRY | None | None |
| P01CA078902 | NIH | None | None |
| K23HL084054 | NIH | None | None |
| P01CA018029 | NIH | None | None |