Study With Rituximab-Gemcitabine/Oxaliplatin in Relapsed Indolent Lymphoma

Multicentric Phase I/II Study for the Efficacy of a Combination of Rituximab, Gemcitabine and Oxaliplatin in Relapsed/Refractory Indolent Lymphoma

The purpose of the phase I part is to determine the tolerability, the initial safety profile and maximum tolerated dose of oxaliplatin in combination with gemcitabine for indolent lymphoma. In the phase II part the investigators want to estimate the activity of gemcitabine and oxaliplatin in combination with rituximab for patients with relapsed/refractory indolent lymphoma.

Inclusion Criteria:

• Need for therapy in patients with relapsed/refractory patients

• Histological proven diagnosis of an indolent B-cell lymphoma according to the World Health Organization (WHO) classification belonging to one of the following entities:

  • follicular lymphoma
  • mantle cell lymphoma
  • lymphoplasmacytic lymphoma
  • nodal or splenic marginal zone lymphoma
  • measurable disease
  • lymphoma specific therapy in the last four weeks
  • WHO performance grade 0, 1 or 2

Exclusion Criteria

• Patients suitable for high dose therapy
• Transformation in high grade lymphoma
• Leukocytes < 1,5/nl or platelets < 100/nl (except due to lymphoma)