drugset
drugset / Trial / NCT02181218

Phase I Study of Romidepsin, Gemcitabine, Oxaliplatin, and Dexamethasone in Patients With Relapsed/Refractory Aggressive Lymphomas

NCT02181218 ↗

Phase 1 Completed 24 enrolled Washington University School of Medicine Celgene Corporation · collab
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this research study is to find the maximum tolerated dose of a drug called romidepsin when given with a treatment regimen called GemOxD. GemOxD is a routine treatment for certain types of lymphoma, and involves the administration of three drugs: gemcitabine, oxaliplatin, and dexamethasone. In addition to finding the maximum tolerated dose of romidepsin, the investigators want to look at the side effects of these drugs when given together, as well as how the lymphoma responds to this treatment.

Timeline

Start
2015-02-04
Primary completion
2019-03-28
Completion
2020-06-26

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Romidepsin Peptide 8 mg/m2 Intravenous
Subject Romidepsin Peptide 10 mg/m2 Intravenous
Subject Romidepsin Peptide 12 mg/m2 Intravenous
Background Dexamethasone Small molecule — Oral
Background Gemcitabine Small molecule — Intravenous
Background Oxaliplatin Small molecule — Intravenous
Background Pegfilgrastim Protein / enzyme biologic — Subcutaneous

Indications

Hodgkins lymphoma diffuse large B-cell lymphoma peripheral T-cell lymphoma, not otherwise specified primary cutaneous T-cell lymphoma