Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00138086
Status:
COMPLETED
Last Update Posted:
2006-09-08
First Post:
2005-08-29
Brief Title:
Yttrium-90 Ibritumomab Tiuxetan Zevalin With BEAM in Relapsed Low Grade B-Cell Lymphoma
Sponsor:
Lymphoma Study Association
Organization:
Lymphoma Study Association
Study Overview
Official Title:
Targeted Intensification by a New Preparative Regimen for Patients With Low-Grade B-Cell Lymphoma Utilizing Standard-Dose Yttrium-90 Ibritumomab Tiuxetan Zevalin Radioimmunotherapy RIT Combined With High-Dose Beam Followed by Autologous Stem Cell Transplantation ASCT
Status:
COMPLETED
Status Verified Date:
2006-09
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:
The objective of this study is to evaluate the efficacy and the safety of Zevalin-BEAM preparative regimen before autologous stem cell transplantation ASCT as measured by the event free survival EFS
The goal is to obtain a 15 increase of EFS at 2 years
The goal is to obtain a 15 increase of EFS at 2 years
Detailed Description:
The indolent course of the low-grade B-cell lymphoma is thus characterized by multiple remissions and relapses with ever-shortening time to progression intervals and by ultimately becoming refractory to treatment In this situation of recurrences intensive therapy including high-dose chemotherapy or chemo-radiotherapy followed by autologous hematopoietic stem cell transplantation appears as a therapeutic option With the use of peripheral blood stem cell the autologous stem cell transplantation ASCT procedure has become easier and cheaper and it has a mortality rate of below 5 and manageable morbidity EBMT registry data or institution driven studies have shown an improvement in event free survival when compared to chemotherapy in relapsing patients Recently Schouten et al reported in a randomized study a significant benefit in survival for patients submitted in relapse to ASCT Consolidation with ASCT has been studied in first line treatment and showed a significant improvement in survival in one randomized study BEAM regimen is a referent high-dose chemotherapy used in intensive therapy followed by ASCT in the treatment of malignant lymphoma It could therefore be considered for patients with indolent lymphoma if it could be shown to improve survival In most studies the conditioning regimen was associating chemotherapy and Total Body Irradiation TBI for indolent lymphoma as it is very sensitive to even low dose of radiotherapy TBI however is time consuming and technically not available in all transplant centers and associated with some long term toxicities a search for more specific targeted irradiation has been a goal for several years
Recently a new preparative regimen for older patients with aggressive CD20-positive B-cell lymphoma utilizing standard-dose 04 mCikg 90Y ibritumomab tiuxetan combined with high-dose BEAM followed by ASCT showed a CR rate of 92 with a follow-up of 9 months Finally high-dose radioimmunotherapy with 90Y ibritumomab tiuxetan and high-dose cyclophosphamideetoposide followed by ASCT for poor-risk or relapsed B-cell NHL have been reported with a 2-year DFS of 80 The use of conventional dose of Yttrium did not need heavy radioprotection procedures and can be widely distributed in transplant centers
Overall toxicities were comparable to standard autologous transplantation conditioning regimens and the combined treatment was well tolerated The hematological reconstitution after transplantation occurred without delay except in two cases than in control-based high-dose chemotherapy alone population Mucositis and neutropenic fever were reported without increase of severity Nonhematological adverse events have been observed three interstitial pneumonitis mild abnormalities on liver or kidney function tests except one case of veno-occlusive disease and 4 fatal infection disseminated aspergillosis with a brain abscess streptococcal sepsis staphylococcal sepsis and disseminated varicella zoster
Therefore all these data support a phase II trial evaluating efficacy and toxicities in patients with low grade B-Cell lymphoma of a new preparative regimen combining a standard dose 90Y ibritumomab tiuxetan and high-dose BEAM chemotherapy followed by ASCT
Recently a new preparative regimen for older patients with aggressive CD20-positive B-cell lymphoma utilizing standard-dose 04 mCikg 90Y ibritumomab tiuxetan combined with high-dose BEAM followed by ASCT showed a CR rate of 92 with a follow-up of 9 months Finally high-dose radioimmunotherapy with 90Y ibritumomab tiuxetan and high-dose cyclophosphamideetoposide followed by ASCT for poor-risk or relapsed B-cell NHL have been reported with a 2-year DFS of 80 The use of conventional dose of Yttrium did not need heavy radioprotection procedures and can be widely distributed in transplant centers
Overall toxicities were comparable to standard autologous transplantation conditioning regimens and the combined treatment was well tolerated The hematological reconstitution after transplantation occurred without delay except in two cases than in control-based high-dose chemotherapy alone population Mucositis and neutropenic fever were reported without increase of severity Nonhematological adverse events have been observed three interstitial pneumonitis mild abnormalities on liver or kidney function tests except one case of veno-occlusive disease and 4 fatal infection disseminated aspergillosis with a brain abscess streptococcal sepsis staphylococcal sepsis and disseminated varicella zoster
Therefore all these data support a phase II trial evaluating efficacy and toxicities in patients with low grade B-Cell lymphoma of a new preparative regimen combining a standard dose 90Y ibritumomab tiuxetan and high-dose BEAM chemotherapy followed by ASCT
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