Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002961
Status:
TERMINATED
Last Update Posted:
2013-10-16
First Post:
1999-11-01
Brief Title:
Chemotherapy With or Without Total-Body Irradiation Prior to Bone Marrow Transplantation in Treating Children With Acute Lymphoblastic Leukemia
Sponsor:
Childrens Hospital of Philadelphia
Organization:
Childrens Hospital of Philadelphia
Study Overview
Official Title:
Randomized Trial of Busulfan or Total Body Irradiation Conditioning Regimens for Children With Acute Lymphoblastic Leukemia
Status:
TERMINATED
Status Verified Date:
2013-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
poor accrual
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 bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells Radiation therapy uses high-energy x-rays to damage cancer cells Combining chemotherapy radiation therapy and bone marrow transplantation may kill more cancer cells
PURPOSE Randomized phase III trial to compare high-dose chemotherapy with or without total-body irradiation before bone marrow transplantation in treating children with acute lymphoblastic leukemia
PURPOSE Randomized phase III trial to compare high-dose chemotherapy with or without total-body irradiation before bone marrow transplantation in treating children with acute lymphoblastic leukemia
Detailed Description:
OBJECTIVES I Compare the efficacy of a busulfan containing conditioning regimen versus a total body irradiation TBI containing regimen for children with acute lymphoblastic leukemia ALL undergoing allogeneic bone marrow transplantation II Compare relapse rate between a chemotherapy only regimen versus a total body irradiation containing regimen for children with ALL III Assess and compare the acute and chronic neuropsychological effects of bone marrow transplantation BMT in children undergoing BMT with busulfan or TBI conditioning regimens IV Assess and compare the cardiac pulmonary and growth effects of BMT in children undergoing this conditioning regimen V Assess the relationship between plasma busulfan levels and relapse and toxicity VI Assess and compare minimal residual disease patterns by quantitative polymerase chain reaction PCR in patients receiving busulfan or TBI conditioning regimens
OUTLINE This is a multicenter randomized study comparing a chemotherapy only arm including busulfan with a TBI containing arm Arm I patients receive TBI on days -7 -6 and -5 given in 2 fractions daily Arm II patients receive busulfan every 6 hours on days -8 -7 -6 and -5 Both regimens are followed by etoposide over 4 hours on day -4 and cyclophosphamide intravenously IV on days -3 and -2 Marrow infusion begins following a day of rest Starting on day -1 cyclosporine IV is administered every 12 hours or by continuous infusion and continues until day 50 Methotrexate IV is administered on days 1 3 and 6
PROJECTED ACCRUAL A total of 230 patients will be entered into this study
OUTLINE This is a multicenter randomized study comparing a chemotherapy only arm including busulfan with a TBI containing arm Arm I patients receive TBI on days -7 -6 and -5 given in 2 fractions daily Arm II patients receive busulfan every 6 hours on days -8 -7 -6 and -5 Both regimens are followed by etoposide over 4 hours on day -4 and cyclophosphamide intravenously IV on days -3 and -2 Marrow infusion begins following a day of rest Starting on day -1 cyclosporine IV is administered every 12 hours or by continuous infusion and continues until day 50 Methotrexate IV is administered on days 1 3 and 6
PROJECTED ACCRUAL A total of 230 patients will be entered into 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-V97-1183 | OTHER | National Cancer Institute | None |
| CHP-BMT-583 | OTHER | None | None |
| BMS-CHP-BMT-583 | OTHER | None | None |