Ignite Creation Date:
2024-05-05 @ 4:48 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00317096
Status:
UNKNOWN
Last Update Posted:
2021-05-07
First Post:
2006-04-20
Brief Title:
FCM Versus R-FCM Followed by R-Maintenance or Observation Only
Sponsor:
Ludwig-Maximilians - University of Munich
Organization:
Ludwig-Maximilians - University of Munich
Study Overview
Official Title:
Treatment of Relapsed CBCC CC and LPIC Lymphoma With FCM Chemotherapy Alone or in Combination With the Monoclonal Anti CD 20 Antibody Rituximab Followed by Anti-CD 20 Maintenance or Observation Only
Status:
UNKNOWN
Status Verified Date:
2021-05
Last Known Status:
ACTIVE_NOT_RECRUITING
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 aim of this phase III trial is to assess the safety and efficacy of treatment with rituximab in combination with FCM chemotherapy R-FCM versus FCM chemotherapy alone for remission induction and to asses the safety and efficacy of rituximab maintenance versus observation only after response to induction therapy Both questions are addressed in way of a prospective randomized comparison in patients with relapsed FL MCL and LP lymphoma
Detailed Description:
Patients with relapsed centroblasticcentrocytic FL centrocytic MCLor lymphoplasmacytoid lymphoma are randomly assigned to either FCM chemotherapy alone or to FCM chemotherapy in combination with the monoclonal anti-CD20 antibody rituximab R-FCM FCM chemotherapy will be given for 4 cycles in intervals of 4 weeks
In patients assigned to cytoreductive therapy with FCM plus rituximab the monoclonal antibody is given as one infusion 375 mgm2 on the day before the respective FCM course for a total of four applications
Four weeks after the end of FCM chemotherapy patients with CR or PR are randomly assigned to either no further treatment or maintenance therapy with rituximab Rituximab will be given 4 times one infusion per week with 375 mgm2 After six months rituximab treatment will be repeated with another 4 infusions
In case of relapse patients will receive an alternative treatment according to the decision of the investigator
The aim of this phase III trial is to assess the safety and efficacy of treatment with rituximab in combination with FCM chemotherapy versus FCM chemotherapy alone for remission induction and to asses the safety and efficacy of rituximab maintenance versus observation only after response to induction therapy Both questions are addressed in way of a prospective randomized comparison in patients with relapsed FCL MCL and LP lymphoma
Primary objectives of this trial are to compare 1 the remission rates CR and PR achieved after FCM plus rituximab versus FCM alone and 2 the progression free interval of rituximab maintenance versus observation only
In patients assigned to cytoreductive therapy with FCM plus rituximab the monoclonal antibody is given as one infusion 375 mgm2 on the day before the respective FCM course for a total of four applications
Four weeks after the end of FCM chemotherapy patients with CR or PR are randomly assigned to either no further treatment or maintenance therapy with rituximab Rituximab will be given 4 times one infusion per week with 375 mgm2 After six months rituximab treatment will be repeated with another 4 infusions
In case of relapse patients will receive an alternative treatment according to the decision of the investigator
The aim of this phase III trial is to assess the safety and efficacy of treatment with rituximab in combination with FCM chemotherapy versus FCM chemotherapy alone for remission induction and to asses the safety and efficacy of rituximab maintenance versus observation only after response to induction therapy Both questions are addressed in way of a prospective randomized comparison in patients with relapsed FCL MCL and LP lymphoma
Primary objectives of this trial are to compare 1 the remission rates CR and PR achieved after FCM plus rituximab versus FCM alone and 2 the progression free interval of rituximab maintenance versus observation only
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