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Predefined termination criterion of > 10 patients without CR or PR was matched.
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rituximab, Gemcitabine and Oxaliplatin | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Remission Rate | end of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | 5 years | |
| Median Overall Survival | 5 years | |
| Toxicity |
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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:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Martin Hoffmann, Dr. | German Low Grade Lymphoma Study Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Ludwigshafen | Ludwigshafen | 67063 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38459156 | Derived | Scheubeck 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. |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D000069283 | Rituximab |
| D000093542 | Gemcitabine |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
|
Number of Participants With Treatment-Related Adverse Events as Assessed by WHO Toxicity Grading Scale
| 5 years |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |