Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Predefined termination criterion of \> 10 patients without CR or PR was matched.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Indolent Lymphoma | Indolent Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Therapy with Rituximab, Gemcitabine and Oxaliplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Rituximab, Gemcitabine and Oxaliplatin
- 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
- interventionNames
- Drug: Therapy with Rituximab, Gemcitabine and Oxaliplatin
Primary outcomes (1)
- measure
- Overall Remission Rate
- timeFrame
- end of therapy
Secondary outcomes (3)
- measure
- Progression Free Survival
- timeFrame
- 5 years
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (1)
- DERIVEDScheubeck G, Hoffmann M, Jurinovic V, Fischer L, Unterhalt M, Schmidt C, Bock HP, Duhrsen U, Kaesberger J, Kremers S, Lindemann HW, Mantovani L, Hiddemann W, Hoster E, Dreyling M; German Lymphoma Alliance (GLA). Rituximab, gemcitabine and oxaliplatin in relapsed or refractory indolent and mantle cell lymphoma: results of a multicenter phase I/II-study of the German Low Grade Lymphoma Study Group. Ann Hematol. 2024 Jul;103(7):2373-2380. doi: 10.1007/s00277-024-05689-w. Epub 2024 Mar 9. PMID 38459156