Study With Rituximab-Gemcitabine/Oxaliplatin in Relapsed Indolent Lymphoma

Sponsor
German Low Grade Lymphoma Study Group
Study ID
NCT00954005
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Indolent Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Therapy with Rituximab, Gemcitabine and Oxaliplatin — DRUG
    Rituximab 375 mg/m² day 0 or 1, Gemcitabine 1.000 mg/m² in 30 Min. day 1 and 15, Oxaliplatin 70 mg/m² in 120 Min. day 1 and 15 (in phase 1 dose escalation of Oxaliplatin in steps of 10 mg/m²), repetition at day 29 for 4 cycles

Study Details

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.

Key Dates

Start date
Jan 31, 2003
Status verified
Aug 2015
Primary completion
Jun 30, 2011
Completion
Jun 30, 2012

Study Design

Enrollment
56 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab, Gemcitabine and Oxaliplatin
    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

Primary Outcome Measure

Overall Remission Rate [ Time Frame: end of therapy ]

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