Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00054327
Status:
COMPLETED
Last Update Posted:
2013-07-24
First Post:
2003-02-05
Brief Title:
Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
Hematopoietic Stem Cell Transplantation Using Bone Marrow Or Peripheral Blood Stem Cells From Matched Unrelated Volunteer Donors
Status:
COMPLETED
Status Verified Date:
2013-06
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 and total-body irradiation before a donor peripheral 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 stem cells from a related donor that do not exactly match the patients blood are infused into the patient they may help the patients bone marrow make stem cells red blood cells white blood cells and platelets
PURPOSE This phase II trial is studying how well giving chemotherapy with or without radiation therapy followed by donor stem cell transplant works in treating patients with hematologic cancer
PURPOSE This phase II trial is studying how well giving chemotherapy with or without radiation therapy followed by donor stem cell transplant works in treating patients with hematologic cancer
Detailed Description:
OBJECTIVES
Determine a standard approach to hematopoietic stem cell transplantation with matched unrelated donors in patients with hematologic malignancies
Determine the toxicity of this regimen in these patients
Determine the relapse rate and survival rate in patients treated with this regimen
Correlate incidence and severity of graft-versus-host disease with relapse and survival in patients treated with this regimen
OUTLINE Patients receive 1 of the following preparative regimens
Regimen A Patients receive cytarabine IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide IV over 2 hours on days -6 and -5 Patients also undergo total body irradiation TBI twice daily on days -4 to -1
Regimen B-1 Patients receive cyclophosphamide IV and TBI as in regimen A
Regimen B-2 Patients receive cyclophosphamide IV over 2 hours on days -5 and -4 Patients also undergo TBI twice daily on days -3 to -1
Regimen B-3 Patients receive TBI on days -7 to -5 Patients receive cyclophosphamide IV over on days -4 to -3
Regimen C Patients receive oral busulfan 4 times daily on days -8 to -5 and cyclophosphamide IV over 2 hours on days -4 to -2
Regimen D Patients receive TBI on days -6 to -4 Patients receive etoposide infusion on day -3
All patients undergo stem cell transplantation from a matched unrelated donor on day 0
Patients are followed weekly for 100 days at 6 months and then every 6 months for 25 years
PROJECTED ACCRUAL 50
Determine a standard approach to hematopoietic stem cell transplantation with matched unrelated donors in patients with hematologic malignancies
Determine the toxicity of this regimen in these patients
Determine the relapse rate and survival rate in patients treated with this regimen
Correlate incidence and severity of graft-versus-host disease with relapse and survival in patients treated with this regimen
OUTLINE Patients receive 1 of the following preparative regimens
Regimen A Patients receive cytarabine IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide IV over 2 hours on days -6 and -5 Patients also undergo total body irradiation TBI twice daily on days -4 to -1
Regimen B-1 Patients receive cyclophosphamide IV and TBI as in regimen A
Regimen B-2 Patients receive cyclophosphamide IV over 2 hours on days -5 and -4 Patients also undergo TBI twice daily on days -3 to -1
Regimen B-3 Patients receive TBI on days -7 to -5 Patients receive cyclophosphamide IV over on days -4 to -3
Regimen C Patients receive oral busulfan 4 times daily on days -8 to -5 and cyclophosphamide IV over 2 hours on days -4 to -2
Regimen D Patients receive TBI on days -6 to -4 Patients receive etoposide infusion on day -3
All patients undergo stem cell transplantation from a matched unrelated donor on day 0
Patients are followed weekly for 100 days at 6 months and then every 6 months for 25 years
PROJECTED ACCRUAL 50
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 |
|---|---|---|---|
| P30CA043703 | NIH | None | None |
| CASE-CWRU-1Y00 | OTHER | Case Comprehensive Cancer Center | httpsreporternihgovquickSearchP30CA043703 |