Phase II Trial of Rituximab Plus 2CdA in Patients With Advanced or Relapsed Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT)
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
After 2, 4 and 6 cycles of therapy
Markus Raderer, Prof. Dr.
AKH Wien / Universitaetsklinik fuer Innere Medizin I
Austria: Federal Office for Safety in Health Care