Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004896
Status:
COMPLETED
Last Update Posted:
2012-06-12
First Post:
2000-03-07
Brief Title:
Busulfan and Cyclophosphamide Followed by Bone Marrow Transplantation in Treating Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Phase II Study of High-Dose Busulfan and Cyclophosphamide Followed by Allogeneic Bone Marrow Transplantation for Patients With Acute Myelogenous Leukemia
Status:
COMPLETED
Status Verified Date:
2012-06
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 Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Combining chemotherapy with donor bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of busulfan and cyclophosphamide followed by bone marrow transplantation in treating patients who have acute myelogenous leukemia or myelodysplastic syndrome
PURPOSE Phase II trial to study the effectiveness of busulfan and cyclophosphamide followed by bone marrow transplantation in treating patients who have acute myelogenous leukemia or myelodysplastic syndrome
Detailed Description:
OBJECTIVES
Determine the remission duration disease-free survival and overall survival of patients with acute myelogenous leukemia in remission or early relapse or myelodysplastic syndrome treated with high-dose busulfan and cyclophosphamide followed by allogeneic bone marrow transplantation
OUTLINE Patients receive oral high-dose busulfan every 6 hours for 14-16 doses on days -9 to -6 followed by high-dose cyclophosphamide IV over 1 hour on days -5 to -2 Allogeneic bone marrow is infused on day 0
Patients who have already had 1 transplant receive high-dose cyclophosphamide IV on days -6 and -5 total body irradiation twice a day on days -4 to -1 and allogeneic bone marrow infusion on day 0
All patients receive prophylaxis for graft versus host disease
Patients are followed every 6 months for at least 2 years
PROJECTED ACCRUAL A total of 25-40 patients will be accrued for this study
Determine the remission duration disease-free survival and overall survival of patients with acute myelogenous leukemia in remission or early relapse or myelodysplastic syndrome treated with high-dose busulfan and cyclophosphamide followed by allogeneic bone marrow transplantation
OUTLINE Patients receive oral high-dose busulfan every 6 hours for 14-16 doses on days -9 to -6 followed by high-dose cyclophosphamide IV over 1 hour on days -5 to -2 Allogeneic bone marrow is infused on day 0
Patients who have already had 1 transplant receive high-dose cyclophosphamide IV on days -6 and -5 total body irradiation twice a day on days -4 to -1 and allogeneic bone marrow infusion on day 0
All patients receive prophylaxis for graft versus host disease
Patients are followed every 6 months for at least 2 years
PROJECTED ACCRUAL A total of 25-40 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 |
|---|---|---|---|
| NCI-G00-1686 | None | None | None |
| NU-91H4T | None | None | None |