Romidepsin, Gemcitabine, Dexamethasone and Cisplatin in the Treatment of Peripheral T-Cell and Diffuse Large B-Cell Lymphoma

Phase 1 Completed 21 enrolled Canadian Cancer Trials Group Celgene Corporation · collab

NaSingle-groupOpen-labelTreatment

Summary

This research is being done because it is not yet known what dose of romidepsin in combination with gemcitabine, dexamethasone, and cisplatin (GDP) can be given safely to patients with peripheral T-cell lymphoma, nor what type and severity of side effects will result from the combination of these treatments. This research is also being done because it is not clear if the addition of the new drug romidepsin to treatment with GDP can offer better results and longer survival.

Timeline

Start: 2013-10-01
Primary completion: 2016-07-06
Completion: 2018-09-19

Publications

Results Reiman T, Savage KJ, Crump M, Cheung MC, MacDonald D, Buckstein R, Couban S, Piliotis E, Imrie K, Spaner D, Shivakumar S, Kuruvilla J, Villa D, Shepherd LE, Skamene T, Winch C, Chen BE, Hay AE. A phase I study of romidepsin, gemcitabine, dexamethasone and cisplatin combination therapy in the treatment of peripheral T-cell and diffuse large B-cell lymphoma; the Canadian cancer trials group LY.15 studydagger. Leuk Lymphoma. 2019 Apr;60(4):912-919. doi: 10.1080/10428194.2018.1515937. Epub 2018 Oct 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cisplatin	Other / unclassified	75 mg/m2	Intravenous
Subject	Dexamethasone	Small molecule	40 mg	Oral
Subject	Gemcitabine	Small molecule	600 mg/m2	Intravenous
Subject	Gemcitabine	Small molecule	1000 mg/m2	Intravenous
Subject	Romidepsin	Peptide	6 mg/m2	—
Subject	Romidepsin	Peptide	8 mg/m2	—
Subject	Romidepsin	Peptide	10 mg/m2	—
Subject	Romidepsin	Peptide	12 mg/m2	—
Subject	Romidepsin	Peptide	14 mg/m2	—

Romidepsin, Gemcitabine, Dexamethasone and Cisplatin in the Treatment of Peripheral T-Cell and Diffuse Large B-Cell Lymphoma

Summary

Timeline

Publications

Drugs

Indications