Ignite Creation Date:
2024-05-05 @ 4:48 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00317785
Status:
COMPLETED
Last Update Posted:
2010-05-07
First Post:
2006-04-24
Brief Title:
Total-Body Irradiation and Cyclophosphamide in Treating Patients Who Are Undergoing Donor Stem Cell Transplant for Hematologic Cancer and Other Diseases
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
A Phase II Trial of Total Body Irradiation Plus Metabolism-Based Cyclophosphamide Dosing as Preparative Therapy for Allogeneic Hematopoietic Cell Transplant for Patients With Hematological Malignancy
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 Giving total-body irradiation and chemotherapy such as cyclophosphamide before a donor stem cell transplant helps stop the patients immune system from rejecting the donors stem cells and helps stop the growth of cancer or abnormal 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 Sometimes the transplanted cells from a donor can make an immune response against the bodys normal cells Giving immunosuppressive therapy before or after transplant may stop this from happening
PURPOSE This phase II trial is studying how well giving total-body irradiation together with cyclophosphamide works in treating patients who are undergoing donor stem cell transplant for hematologic cancer and other diseases
PURPOSE This phase II trial is studying how well giving total-body irradiation together with cyclophosphamide works in treating patients who are undergoing donor stem cell transplant for hematologic cancer and other diseases
Detailed Description:
OBJECTIVES
Primary
Evaluate the potential efficacy of targeting cyclophosphamide to a metabolic endpoint when given together with total-body irradiation in terms of day 200 nonrelapse mortality in patients with hematologic cancer and other diseases who are undergoing allogeneic hematopoietic stem cell transplantation
Secondary
Determine the overall survival of patients treated with this regimen
Determine the rate of relapse in patients treated with this regimen
Determine the occurrence of sinusoidal obstruction syndrome in patients treated with this regimen
Determine the occurrence of acute renal failure in these patients
Determine the occurrence of respiratory failure in these patients
OUTLINE
Conditioning regimen Patients undergo total-body irradiation twice daily on days -6 to -4 Patients also receive cyclophosphamide IV over 1 hour on day -3 and then IV at a metabolism-based dose on day -2
NOTE Patients undergo frequent blood sampling after completion of the first cyclophosphamide infusion for pharmacokinetic studies in order to determine the dose for the second cyclophosphamide infusion
Allogeneic stem cell transplantation Patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0
Graft-versus-host disease GVHD prophylaxis Patients receive GVHD prophylaxis as per the attending physician including one of the following regimens cyclosporine and methotrexate tacrolimus and methotrexate tacrolimus and mycophenolate mofetil or sirolimus tacrolimus and methotrexate as per the GVHD prophylaxis regimen chosen for each patient
After completion of study treatment patients are followed periodically for at least 200 days
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study
Primary
Evaluate the potential efficacy of targeting cyclophosphamide to a metabolic endpoint when given together with total-body irradiation in terms of day 200 nonrelapse mortality in patients with hematologic cancer and other diseases who are undergoing allogeneic hematopoietic stem cell transplantation
Secondary
Determine the overall survival of patients treated with this regimen
Determine the rate of relapse in patients treated with this regimen
Determine the occurrence of sinusoidal obstruction syndrome in patients treated with this regimen
Determine the occurrence of acute renal failure in these patients
Determine the occurrence of respiratory failure in these patients
OUTLINE
Conditioning regimen Patients undergo total-body irradiation twice daily on days -6 to -4 Patients also receive cyclophosphamide IV over 1 hour on day -3 and then IV at a metabolism-based dose on day -2
NOTE Patients undergo frequent blood sampling after completion of the first cyclophosphamide infusion for pharmacokinetic studies in order to determine the dose for the second cyclophosphamide infusion
Allogeneic stem cell transplantation Patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0
Graft-versus-host disease GVHD prophylaxis Patients receive GVHD prophylaxis as per the attending physician including one of the following regimens cyclosporine and methotrexate tacrolimus and methotrexate tacrolimus and mycophenolate mofetil or sirolimus tacrolimus and methotrexate as per the GVHD prophylaxis regimen chosen for each patient
After completion of study treatment patients are followed periodically for at least 200 days
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study
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 |
|---|---|---|---|
| FHCRC-199800 | None | None | None |
| CDR0000471840 | REGISTRY | PDQ | None |