Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00137995
Status:
COMPLETED
Last Update Posted:
2019-08-28
First Post:
2005-08-25
Brief Title:
R-ICE Versus R-DHAP in Patients Aged 18-65 With Relapse Diffuse Large B-cell Lymphoma
Sponsor:
Lymphoma Study Association
Organization:
Lymphoma Study Association
Study Overview
Official Title:
Randomized Study of ICE Plus RITUXIMAB Versus DHAP Plus Rituximab in Previously Treated Patients With Diffuse Large B-cell Lymphoma Followed by Randomized Maintenance With Rituximab
Status:
COMPLETED
Status Verified Date:
2019-08
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 primary objective of this study is to evaluate the efficacy and safety of induction therapy R-ICE in comparison to R-DHAP after 3 cycles adjusted to successful mobilization of stem cells in patients with previously treated diffuse large B-cell lymphoma CD20
The goal is to detect a difference in mobilization adjusted response rate of 15 between R-ICE and R-DHAP
The other objective is to evaluate the efficacy and safety of MabThera maintenance therapy after transplantation as measured by the event free survival
The goal is to obtain a 15 increase of event free survival at 2 years
The goal is to detect a difference in mobilization adjusted response rate of 15 between R-ICE and R-DHAP
The other objective is to evaluate the efficacy and safety of MabThera maintenance therapy after transplantation as measured by the event free survival
The goal is to obtain a 15 increase of event free survival at 2 years
Detailed Description:
In vitro the addition of rituximab to standard anticancer drugs increases cell lyses even in chemoresistant cell lines This chemosensitization effect was also demonstrated in vivo by the results of the GELA trial in elderly patients with DLCL Reported phase II study results on the RICE regimen for treatment of patients with relapsed DLCL and comparison with historical controls being treated with ICE suggests that this effect 15 improvement in response rate is likely in relapsing DLCL and had led the SWOG to stop a randomized trial comparing ICE vs RICE in patients with relapsed aggressive lymphoma
In the setting of relapsed DLCL high dose therapy HDT followed by autologous stem cell transplantation ASCT remains the standard to improve survival in highly selected chemosensitive patients In the Parma study only 58 of the patients with relapsed aggressive NHL were good responders after DHAP and 24 were in complete remission Moreover the quality of response depended on prognostic factors such as IPI and relapse 12 months after treatment and only patients responding to salvage therapy benefited from HDT ASCT As shown in the PARMA study The goal in relapsed DLCL is to improve complete response rates before transplantation as it is the main parameter for eligibility for HDT ASCT and the main prognostic factor Unlike first line treatment with CHOP no standard chemotherapy exists for relapsing patients DHAP has been the most frequently used regimen for decades but incorporates only two drugs and has dose-limiting renal toxicity The ICE regimen was developed at several dosages and studies consistently produced CR rates that were 10-15 superior to DHAP It is expected that this difference will remain the same with the addition of rituximab to both regimens Recent phase II data in patients with relapsed DLCL not previously treated with rituximab showed that RICE produced a response rate of 78 with a complete remission rate of 58 and was active in primary refractory disease as well as in intermediate-high risk patients IPI 2-3 Association of DHAP to Rituximab R-DHAP has been done on small series of patients by investigators including patients relapsing after autotransplant Despite numerous phase II studies no randomized study has been performed comparing the two regimens DHAPICE or others in relapsing DLCL Treatment of first line DLCL has been changed in the past 10 years with more intensive regimens often followed by ASCT and very recently with the addition of rituximab to chemotherapy and therefore the population of relapsing patients might be different from the one in the initial PARMA study A large lymphoma intergroup study working on a large prospective data base might help to find the best salvage regimen and to assess the role of retreatment with monoclonal antibodies in these patients Finally the role of rituximab maintenance therapy after HDT ASCT in prolonging second complete response should be evaluated
In the setting of relapsed DLCL high dose therapy HDT followed by autologous stem cell transplantation ASCT remains the standard to improve survival in highly selected chemosensitive patients In the Parma study only 58 of the patients with relapsed aggressive NHL were good responders after DHAP and 24 were in complete remission Moreover the quality of response depended on prognostic factors such as IPI and relapse 12 months after treatment and only patients responding to salvage therapy benefited from HDT ASCT As shown in the PARMA study The goal in relapsed DLCL is to improve complete response rates before transplantation as it is the main parameter for eligibility for HDT ASCT and the main prognostic factor Unlike first line treatment with CHOP no standard chemotherapy exists for relapsing patients DHAP has been the most frequently used regimen for decades but incorporates only two drugs and has dose-limiting renal toxicity The ICE regimen was developed at several dosages and studies consistently produced CR rates that were 10-15 superior to DHAP It is expected that this difference will remain the same with the addition of rituximab to both regimens Recent phase II data in patients with relapsed DLCL not previously treated with rituximab showed that RICE produced a response rate of 78 with a complete remission rate of 58 and was active in primary refractory disease as well as in intermediate-high risk patients IPI 2-3 Association of DHAP to Rituximab R-DHAP has been done on small series of patients by investigators including patients relapsing after autotransplant Despite numerous phase II studies no randomized study has been performed comparing the two regimens DHAPICE or others in relapsing DLCL Treatment of first line DLCL has been changed in the past 10 years with more intensive regimens often followed by ASCT and very recently with the addition of rituximab to chemotherapy and therefore the population of relapsing patients might be different from the one in the initial PARMA study A large lymphoma intergroup study working on a large prospective data base might help to find the best salvage regimen and to assess the role of retreatment with monoclonal antibodies in these patients Finally the role of rituximab maintenance therapy after HDT ASCT in prolonging second complete response should be evaluated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None