Study With Rituximab-Gemcitabine/Oxaliplatin in Relapsed Indolent Lymphoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2012-06-30

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.

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Detailed Description

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Conditions

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Indolent Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Therapy with Rituximab, Gemcitabine and Oxaliplatin

Intervention Type 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

Interventions

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Therapy with Rituximab, Gemcitabine and Oxaliplatin

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

Intervention Type DRUG

Other Intervention Names

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Rituximab = Mabthera, Rituxan Gemcitabine = Gemzar Oxaliplatin = Eloxatin

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No