Study With Rituximab-Gemcitabine/Oxaliplatin in Relapsed Indolent Lymphoma (R-GO)

German Low Grade Lymphoma Study Group

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Indolent Lymphoma

Treatments: Drug: Therapy with Rituximab, Gemcitabine and Oxaliplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00954005

001

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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56 participants in 1 patient group

Rituximab, Gemcitabine and Oxaliplatin

Experimental group

Description:

Drug: Rituximab on day 0 or 1 of each 28-day cycle Drug: Gemcitabine on day 1 and 15 of each 28-day cycle Drug: Oxaliplatin on day 1 and 15 (in phase 1 dose escalation of Oxaliplatin in steps of 10 mg/m²) of each 28-day cycle

Treatment:

Drug: Therapy with Rituximab, Gemcitabine and Oxaliplatin