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

Status

Terminated

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00954005

Acronym

R-GO

Enrollment

Registered

2009-08-06

Start date

2003-01-31

Completion date

2012-06-30

Last updated

2015-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Indolent Lymphoma

Keywords

relapsed indolent lymphoma, gemcitabine, oxaliplatin, rituximab

Brief summary

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.

Interventions

DRUGTherapy 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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
Overall Remission Rate	end of therapy

Secondary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026