Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00397813
Status:
COMPLETED
Last Update Posted:
2020-01-31
First Post:
2006-11-09
Brief Title:
Fludarabine Phosphate and Total Body Irradiation Followed by a Donor Peripheral Stem Cell Transplant in Treating Patients With Myelodysplastic Syndromes or Myeloproliferative Disorders
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Low-Dose TBI Dose Escalation to Decrease Risks of Progression and Graft Rejection After Hematopoietic Cell Transplantation With Nonmyeloablative Conditioning as Treatment for Untreated Myelodysplastic Syndrome or Myeloproliferative Disorders - A Multi-Center Trial
Status:
COMPLETED
Status Verified Date:
2020-01
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:
This phase II trial studies the side effects and best dose of total-body irradiation when given together with fludarabine phosphate followed by a donor peripheral stem cell transplant in treating patients with myelodysplastic syndromes MDS or myeloproliferative disorders MPD Giving low doses of chemotherapy such as fludarabine phosphate and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells Giving chemotherapy or radiation therapy before or after transplant also stops the patients immune system from rejecting the donors stem cells The donated stem cells may replace the patients immune cells and help destroy any remaining cancer cells graft-versus-tumor effect Sometimes the transplanted cells from a donor can also make an immune response against the bodys normal cells Giving cyclosporine and mycophenolate mofetil after the transplant may stop this from happening
Detailed Description:
PRIMARY OBJECTIVES
I Decrease the incidence of day-200 hematopoietic cell transplantation HCT failure to 20 in patients with MDS-Refractory anemia RA-ringed sideroblasts RSMPD and in patients with chronic myelomonocytic leukemia CMMLrefractory anemia with excess blasts RAEB
SECONDARY OBJECTIVES
I The rate of relapseprogression in patients with MPD or MDS-RA and those with CMML or MDS-RAEB
II The probability of progression free survival PFS in patients with MPD or MDS-RA and those with CMML or MDS-RAEB
III The kinetics of donor engraftment
IV The incidence of infections
OUTLINE This is a dose-escalation study of total body irradiation TBI
NONMYELOABLATIVE CONDITIONING REGIMEN Patients receive fludarabine phosphate intravenously IV on days -4 to -2 and undergo TBI on day 0
PERIPHERAL BLOOD STEM CELL PBSC TRANSPLANTATION Patients undergo filgrastim G-CSF-mobilized PBSC infusion after TBI on day 0
IMMUNOSUPPRESSION
Matched Related Donor Patients receive cyclosporine orally PO twice daily BID on days -3 to 56 followed by a taper until day 180 Patients also receive mycophenolate mofetil MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27
Unrelated Donor Patients receive cyclosporine PO BID on days -3 to 100 followed by a taper until day 180 Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40 followed by a taper until day 96
After completion of study treatment patients are followed periodically
I Decrease the incidence of day-200 hematopoietic cell transplantation HCT failure to 20 in patients with MDS-Refractory anemia RA-ringed sideroblasts RSMPD and in patients with chronic myelomonocytic leukemia CMMLrefractory anemia with excess blasts RAEB
SECONDARY OBJECTIVES
I The rate of relapseprogression in patients with MPD or MDS-RA and those with CMML or MDS-RAEB
II The probability of progression free survival PFS in patients with MPD or MDS-RA and those with CMML or MDS-RAEB
III The kinetics of donor engraftment
IV The incidence of infections
OUTLINE This is a dose-escalation study of total body irradiation TBI
NONMYELOABLATIVE CONDITIONING REGIMEN Patients receive fludarabine phosphate intravenously IV on days -4 to -2 and undergo TBI on day 0
PERIPHERAL BLOOD STEM CELL PBSC TRANSPLANTATION Patients undergo filgrastim G-CSF-mobilized PBSC infusion after TBI on day 0
IMMUNOSUPPRESSION
Matched Related Donor Patients receive cyclosporine orally PO twice daily BID on days -3 to 56 followed by a taper until day 180 Patients also receive mycophenolate mofetil MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27
Unrelated Donor Patients receive cyclosporine PO BID on days -3 to 100 followed by a taper until day 180 Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40 followed by a taper until day 96
After completion of study treatment patients are followed 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 |
|---|---|---|---|
| P30CA015704 | NIH | Fred HutchUniversity of Washington Cancer Consortium | httpsreporternihgovquickSearchP30CA015704 |
| NCI-2010-00237 | REGISTRY | None | None |
| 205600 | OTHER | None | None |
| P01CA018029 | NIH | None | None |