Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00054340
Status:
COMPLETED
Last Update Posted:
2010-05-14
First Post:
2003-02-05
Brief Title:
Combination Chemotherapy and Antithymocyte Globulin in Reducing Graft-Versus-Host Disease in Patients Undergoing Donor Stem Cell Transplantation For Myelodysplastic Syndrome or Myeloproliferative Disorder
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Conditioning With Targeted Busulfan Cyclophosphamide and Thymoglobulin for Allogeneic Marrow or Peripheral Blood Stem Cell PBSC Transplantation for Myelodysplasia and Myeloproliferative Disorders
Status:
COMPLETED
Status Verified Date:
2010-05
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 Combining antithymocyte globulin with combination chemotherapy before donor peripheral stem cell transplantation may reduce the chance of developing graft-versus-host disease following transplantation
PURPOSE Phase III trial to study the effectiveness of combining antithymocyte globulin with busulfan and cyclophosphamide in reducing graft-versus-host disease in patients who are undergoing donor stem cell transplantation for myelodysplastic syndrome or other myeloproliferative disorder
PURPOSE Phase III trial to study the effectiveness of combining antithymocyte globulin with busulfan and cyclophosphamide in reducing graft-versus-host disease in patients who are undergoing donor stem cell transplantation for myelodysplastic syndrome or other myeloproliferative disorder
Detailed Description:
OBJECTIVES
Determine the incidence of acute graft-vs-host disease GVHD requiring therapy in patients with myelodysplastic syndromes or myeloproliferative disorders treated with busulfan cyclophosphamide and anti-thymocyte globulin prior to transplantation with filgrastim G-CSF-mobilized peripheral blood stem cells or bone marrow from related or unrelated donors
Determine the incidence of relapse and relapse-free survival in patients treated with this regimen
Determine the incidence of non-relapse mortality by day 100 and 1 year posttransplantation in patients treated with this regimen
Determine the incidence of Epstein-Barr virus reactivation infections and chronic GVHD in patients treated with this regimen
OUTLINE This is a dose-escalation study of anti-thymocyte globulin
Conditioning and graft-vs-host disease GVHD prophylaxis Patients receive oral busulfan every 6 hours on days -7 to -4 16 doses cyclophosphamide IV on days -3 and -2 and anti-thymocyte globulin IV over 3 hours on days -3 -2 and -1
Cohorts of 15 patients receive adjusted doses of anti-thymocyte globulin to determine the optimal dose at which Epstein-Barr virus EBV activation and GVHD are reduced The optimal dose is the dose at which 2 consecutive cohorts receive the same regimen
Stem cell transplantation Patients undergo peripheral blood stem cell PBSC or bone marrow transplantation on day 0
Posttransplantation GVHD prophylaxis Patients receive cyclosporine IV continuously on days -1 to 4 and then orally twice daily until day 180 Patients also receive methotrexate on days 1 3 6 and 11
Patients are followed every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 30-45 patients will be accrued for this study within 2 years
Determine the incidence of acute graft-vs-host disease GVHD requiring therapy in patients with myelodysplastic syndromes or myeloproliferative disorders treated with busulfan cyclophosphamide and anti-thymocyte globulin prior to transplantation with filgrastim G-CSF-mobilized peripheral blood stem cells or bone marrow from related or unrelated donors
Determine the incidence of relapse and relapse-free survival in patients treated with this regimen
Determine the incidence of non-relapse mortality by day 100 and 1 year posttransplantation in patients treated with this regimen
Determine the incidence of Epstein-Barr virus reactivation infections and chronic GVHD in patients treated with this regimen
OUTLINE This is a dose-escalation study of anti-thymocyte globulin
Conditioning and graft-vs-host disease GVHD prophylaxis Patients receive oral busulfan every 6 hours on days -7 to -4 16 doses cyclophosphamide IV on days -3 and -2 and anti-thymocyte globulin IV over 3 hours on days -3 -2 and -1
Cohorts of 15 patients receive adjusted doses of anti-thymocyte globulin to determine the optimal dose at which Epstein-Barr virus EBV activation and GVHD are reduced The optimal dose is the dose at which 2 consecutive cohorts receive the same regimen
Stem cell transplantation Patients undergo peripheral blood stem cell PBSC or bone marrow transplantation on day 0
Posttransplantation GVHD prophylaxis Patients receive cyclosporine IV continuously on days -1 to 4 and then orally twice daily until day 180 Patients also receive methotrexate on days 1 3 6 and 11
Patients are followed every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 30-45 patients will be accrued for this study within 2 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 |
|---|---|---|---|
| CDR0000270397 | REGISTRY | PDQ | None |
| FHCRC-172300 | None | None | None |