Study With Rituximab-Gemcitabine/Oxaliplatin in Relapsed Indolent Lymphoma

Study Overview
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Brief Summary
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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.

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

Conditions
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Indolent Lymphoma

Intervention / Treatment
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* Drug: Therapy with Rituximab, Gemcitabine and Oxaliplatin


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rituximab, Gemcitabine and Oxaliplatin<br>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 | Drug: Therapy with Rituximab, Gemcitabine and Oxaliplatin<br>* 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<br>* Other names: Oxaliplatin = Eloxatin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Remission Rate |  | end of therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival |  | 5 years | 
| Median Overall Survival |  | 5 years | 
| Toxicity | Number of Participants With Treatment-Related Adverse Events as Assessed by WHO Toxicity Grading Scale | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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relapsed indolent lymphoma, gemcitabine, oxaliplatin, rituximab