A Phase II Study for Patients With Indolent Non-follicular Non-Hodgkin's Lymphoma (IIL INFL09)
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|ClinicalTrials.gov Identifier: NCT01929265|
Recruitment Status : Completed
First Posted : August 27, 2013
Last Update Posted : October 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Indolent Non-follicular Non-Hodgkin's Lymphoma||Drug: Bendamustine||Phase 2|
This is a prospective, multicenter phase II trial designed to determine efficacy and safety of a chemoimmunotherapy with the combination of Bendamustine + Rituximab in patients with advanced untreated Indolent non Follicular non-Hodgkin Lymphomas (INFL).
The study includes and induction phase and a consolidation phase.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||73 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Bendamustine in Combination With Rituximab as Initial Treatment for Patients With Indolent Non-follicular Non-Hodgkin's Lymphoma|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||May 2015|
Experimental: Rituximab - Bendamustine (RB)
1 arm: Rituximab - Bendamustine (RB)
1 arm for all patients
Rituximab - Bendamustine (RB): cycles 1 to 4 (0, 4, 8, 12 week):
Rituximab: 375 mg/sqm iv, day 1*
Bendamustine: 90 mg/sqm iv, days 1-2 or days 2-3 according to istitutional/patient/physician choice
Repeat cycles every 28 days for a total of 4 cycles
*In cycle 1, in order to avoid tumor lysis syndrome, Rituximab will be given on day 8.
Rituximab - Bendamustine (RB): cycles 5 to 6 (16, 20 week):
Rituximab: 375 mg/sqm iv day 1
Bendamustine: 90 mg/sqm iv days 1-2 or days 2-3 according to istitutional/patient/physician choice
Rituximab two monthly doses
Rituximab: 375 mg/sqm iv week 24 and 28
Other Name: RIBOMUSTIN
- Complete remission rate (CR) [ Time Frame: 5 months ]Evaluated at the end of treatment
- Safety analysis [ Time Frame: 5 months ]Evaluated during and at the end of treatment. Percentage of patients with adverse, hematological and non-hematological toxic events
- Overall response rate (ORR) [ Time Frame: 5 months ]Evaluated at the end of treatment. Complete plus partial remission.
- Overall survival (OS) [ Time Frame: at 2 years ]Dead for any causes after diagnosis. Evaluated by means of Kaplan-Meier method.
- Progression free survival (PFS) [ Time Frame: at 2 years ]Progression, relapse or dead for any causes after diagnosis. Evaluated by means of Kaplan-Meier method.
- Disease free survival (PFS) [ Time Frame: at 2 years ]Relapse or dead for any causes from the end of treatment, for patients in CR after B+R. Evaluated by means of Kaplan-Meier method.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01929265
|Principal Investigator:||Luca Baldini, Prof.||UOC Ematologia 1/CTMO, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico|