Study With Rituximab-Gemcitabine/Oxaliplatin in Relapsed Indolent Lymphoma

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.

Timeline

Start

2003-01

Primary completion

2011-06

Completion

2012-06

Outcome

Missed primary endpoint

Stopped: “Predefined termination criterion of \> 10 patients without CR or PR was matched.”

paper Among 46 patients evaluable for the efficacy analysis ORR was 72% (33/46), missing the primary aim of the study (p = 0.21). PMID 38459156 ↗

Publications

• 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Gemcitabine	Small molecule	1000 mg/m2	—
Subject	Oxaliplatin	Small molecule	70 mg/m2	—
Subject	Oxaliplatin	Small molecule	80 mg/m2	—
Subject	Rituximab	Monoclonal antibody	375 mg/m2	—

Indications