Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004255
Status:
COMPLETED
Last Update Posted:
2013-07-10
First Post:
2000-01-28
Brief Title:
Treatment of Bone Marrow to Prevent Graft-Versus-Host Disease in Patients With Acute or Chronic Leukemia Undergoing Bone Marrow Transplantation
Sponsor:
Chimeric Therapies
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Multi-Center Open Label Randomized Active Controlled Phase IIIII Clinical Trial to Evaluate the Safety and Efficacy of Processed Unrelated Bone Marrow in Patients With Acute or Chronic Leukemia
Status:
COMPLETED
Status Verified Date:
2002-02
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 Bone marrow that has been treated to remove certain white blood cells may reduce the chance of developing graft-versus-host disease following bone marrow transplantation
PURPOSE Randomized phase IIIII trial to compare the effectiveness of treated bone marrow with that of untreated bone marrow in preventing graft-versus-host disease in patients with acute or chronic leukemia who are undergoing bone marrow transplantation
PURPOSE Randomized phase IIIII trial to compare the effectiveness of treated bone marrow with that of untreated bone marrow in preventing graft-versus-host disease in patients with acute or chronic leukemia who are undergoing bone marrow transplantation
Detailed Description:
OBJECTIVES
Compare the efficacy of processed cell depleted vs unprocessed conventional unrelated bone marrow transplantation in reducing grade IIIIV acute graft vs host disease GVHD in patients with acute or chronic leukemia or myelodysplastic syndromes
Compare the safety of these regimens in these patients
Compare the disease-free survival rate at 100 days and at 6 months in patients treated with these regimens
Compare the time to engraftment and percent engraftment in patients treated with these regimens
Compare the reduction rate of grade II or greater acute and chronic GVHD in patients treated with these regimens
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to degree of HLA matching and disease chronic vs acute Acute myelogenous leukemia patients are further stratified according to prior myelodysplastic syndromes yes vs no Patients are randomized to one of two bone marrow transplantation arms
All patients receive a conditioning regimen comprising fludarabine IV on day -6 cyclophosphamide IV on days -5 and -4 anti-thymocyte globulin IV on days -4 and -2 and total body irradiation on days -3 to 0 Patients also receive methylprednisolone IV every 12 hours for 4 doses on days -2 to 0 Tacrolimus IV is administered continuously on day -1 and continues either orally or IV for 6 months Bone marrow is infused on day 0 Filgrastim G-CSF is administered subcutaneously from day 0 until blood counts recover
Arm I Patients receive allogeneic bone marrow that has been processed to produce a mononuclear cell preparation
Arm II Patients receive unprocessed allogeneic bone marrow Patients are followed weekly for 100 days and then at 6 months
PROJECTED ACCRUAL A total of 260 patients will be accrued for this study within 17 months
Compare the efficacy of processed cell depleted vs unprocessed conventional unrelated bone marrow transplantation in reducing grade IIIIV acute graft vs host disease GVHD in patients with acute or chronic leukemia or myelodysplastic syndromes
Compare the safety of these regimens in these patients
Compare the disease-free survival rate at 100 days and at 6 months in patients treated with these regimens
Compare the time to engraftment and percent engraftment in patients treated with these regimens
Compare the reduction rate of grade II or greater acute and chronic GVHD in patients treated with these regimens
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to degree of HLA matching and disease chronic vs acute Acute myelogenous leukemia patients are further stratified according to prior myelodysplastic syndromes yes vs no Patients are randomized to one of two bone marrow transplantation arms
All patients receive a conditioning regimen comprising fludarabine IV on day -6 cyclophosphamide IV on days -5 and -4 anti-thymocyte globulin IV on days -4 and -2 and total body irradiation on days -3 to 0 Patients also receive methylprednisolone IV every 12 hours for 4 doses on days -2 to 0 Tacrolimus IV is administered continuously on day -1 and continues either orally or IV for 6 months Bone marrow is infused on day 0 Filgrastim G-CSF is administered subcutaneously from day 0 until blood counts recover
Arm I Patients receive allogeneic bone marrow that has been processed to produce a mononuclear cell preparation
Arm II Patients receive unprocessed allogeneic bone marrow Patients are followed weekly for 100 days and then at 6 months
PROJECTED ACCRUAL A total of 260 patients will be accrued for this study within 17 months
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 |
|---|---|---|---|
| WSU-10-02-99-M01-FB | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000067502 | REGISTRY | None | None |