Rituximab Plus 2CdA in Patients With Advanced or Relapsed Mucosa Associated Lymphoid Tissue (MALT) Lymphoma
The purpose of this trial is to evaluate whether a Rituximab plus 2 CdA combination therapy is effective and safe in the treatment of patients with advanced or relapsed lymphoma of the mucosa associated lymphoid tissue (MALT).
Lymphoma of Mucosa-Associated Lymphoid Tissue
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Rituximab Plus 2CdA in Patients With Advanced or Relapsed Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT)|
- Response rate [ Time Frame: After 2, 4 and 6 cycles of therapy ] [ Designated as safety issue: No ]
- Progression-free survival and relapse-free survival [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
- Occurrence of adverse events [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2008|
|Estimated Study Completion Date:||December 2011|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Experimental: Treatment Arm
Combination therapy Rituximab plus 2CdA
375 mg/m2 on day 1 of a 21-day treatment cycle
Other Name: MabTheraDrug: 2-CdA
0.1 mg/kg s.c. on days 1 - 4 of a 21-day treatment cycle
Other Name: Litak
Currently, there is no chemotherapeutic standard treatment for patients with MALT lymphoma either presenting with disseminated disease or with relapsing/refractory disease following local treatment (including radiation) or eradication of HP. Various compounds have been tested, including alkylating agents such as cyclophosphamide or chlorambucil, the nucleoside analog cladribine (2CdA), as well as combination regimens including CHOP or MCP (mitoxantrone, chlorambucil, prednisone), but only limited data exists from prospective trials. Thus, trials to evaluate the potential of new compounds in patients with advanced MALT lymphoma are not only justified, but seem warranted.
While systemic approaches were until recently thought to be justified only in patients with disseminated disease, emerging data suggest that also patients with localized disease potentially amenable to radiation may benefit from systemic treatment. This has been demonstrated for ocular adnexal MALT lymphoma and recently also for gastric MALT lymphoma in a randomized fashion, where application of chemotherapy resulted in a significantly longer time to relapse as opposed to surgery or radiation without impairing overall survival.
Both 2CdA and rituximab have been demonstrated as active single agents in MALT lymphoma with mild toxicity profiles and no data on combination therapy with rituximab plus chemotherapy in MALT lymphoma have been published to date. This study will therefore evaluate the efficacy and safety of Rituximab plus 2CdA in patients with advanced or relapsed lymphoma of the mucose associated lymphoid tissue.
|Graz, Austria, A-8036|
|Universitaetsklinik Innsbruck/ Klinik für Innere Medizin|
|Innsbruck, Austria, A-6020|
|Krankenhaus der Stadt Linz|
|Linz, Austria, A-4020|
|Universitaetsklinik f. Innere Medizin III|
|Salzburg, Austria, A-5020|
|AKH Wien / Universitaetsklinik fuer Innere Medizin I|
|Vienna, Austria, A-1090|
|Principal Investigator:||Markus Raderer, Prof. Dr.||AKH Wien / Universitaetsklinik fuer Innere Medizin I|