Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00336843
Status:
COMPLETED
Last Update Posted:
2016-02-17
First Post:
2006-06-13
Brief Title:
Zevalin Plus BuCyE High-dose Therapy in B-cell Non-Hodgkins Lymphoma
Sponsor:
Asan Medical Center
Organization:
Asan Medical Center
Study Overview
Official Title:
Combining 90Y-ibritumomab Tiuxetan With High-dose Chemotherapy of BuCyE and Autologous Stem Cell Transplantation in Patients With B-cell Non-Hodgkins Lymphoma - an Open-labeled Phase II Study
Status:
COMPLETED
Status Verified Date:
2016-02
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:
In order to improve the clinical result of high-dose chemotherapy and autologous stem cell transplantation for B-cell non-Hodgkins lymphoma Zevalin will be added to the conditioning regimen Investigators expect this radioimmunotherapy of Zevalin plus busulfan cyclophosphamide and etoposide regimen will improve survival of relapsed or poor-risk B-cell non-Hodgkins lymphoma
Detailed Description:
Title Combining 90Y-Ibritumomab tiuxetan Zevalin with high-dose chemotherapy of BuCyE and autologous stem cell transplantation in patients with relapsed refractory or high-risk B-cell non-Hodgkins lymphoma - an open-labeled phase II study
Study design Prospective multicenter open-labeled phase II trial
Study objectives
Primary event-free survival time following autologous stem cell transplantation with 90Y-Ibritumomab tiuxetan and BuCyE high-dose chemotherapy in patients with relapsed refractory or high-risk B-cell non-Hodgkins lymphoma
Secondary overall survival response rate toxicity of the treatment combination
Treatment
Z-BuCyE Regimen
Day 21 rituximab 250 mgm2 IV
Day 14 rituximab 250 mgm2 IV 90Y-Ibritumomab tiuxetan 04 mCikg IV
Day 7 6 5 busulfan 32 mgkg IV
Day 5 4 etoposide 200 mgm2 IV every 12 hours
Day 3 2 Cytoxan 50 mgkg IV
Day 0 autologous stem cell infusion
Study design Prospective multicenter open-labeled phase II trial
Study objectives
Primary event-free survival time following autologous stem cell transplantation with 90Y-Ibritumomab tiuxetan and BuCyE high-dose chemotherapy in patients with relapsed refractory or high-risk B-cell non-Hodgkins lymphoma
Secondary overall survival response rate toxicity of the treatment combination
Treatment
Z-BuCyE Regimen
Day 21 rituximab 250 mgm2 IV
Day 14 rituximab 250 mgm2 IV 90Y-Ibritumomab tiuxetan 04 mCikg IV
Day 7 6 5 busulfan 32 mgkg IV
Day 5 4 etoposide 200 mgm2 IV every 12 hours
Day 3 2 Cytoxan 50 mgkg IV
Day 0 autologous stem cell infusion
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