NCT02181218

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

Completed Phase 1 Last updated 17 November 2020

What this trial tests

Phase 1 trial testing Romidepsin in Lymphoma, T-Cell, Cutaneous in 24 participants. Completed in 26 June 2020.

Timeline

4 February 2015

Primary endpoint
28 March 2019

26 June 2020

Quick facts

Lead sponsor	Washington University School of Medicine
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	24
Start date	4 February 2015
Primary completion	28 March 2019
Estimated completion	26 June 2020
Sites	2 locations across United States

Drugs / interventions tested

• Romidepsin (ROMIDEPSIN) — full drug profile →
• Gemcitabine (gemcitabine) — full drug profile →
• Oxaliplatin (Oxaliplatin) — full drug profile →
• Dexamethasone (dexamethasone) — full drug profile →
• Pegfilgrastim (PEGFILGRASTIM) — full drug profile →

Conditions studied

• Lymphoma, T-Cell, Cutaneous — all drugs for Lymphoma, T-Cell, Cutaneous →
• Lymphoma, T-Cell, Peripheral — all drugs for Lymphoma, T-Cell, Peripheral →
• Hodgkin Disease — all drugs for Hodgkin Disease →
• Lymphoma, Large B-Cell, Diffuse — all drugs for Lymphoma, Large B-Cell, Diffuse →

Sponsor

Washington University School of Medicine

Who can join

18 and older, any sex, with Lymphoma, T-Cell, Cutaneous or Lymphoma, T-Cell, Peripheral. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Trial Watch: Immunogenic cell death inducers for anticancer chemotherapy.
   Pol J, Vacchelli E, Aranda F, Castoldi F, et al · · 2015 · cited 238× · PMID 26137404 · DOI 10.1080/2162402x.2015.1008866
2. Epigenetic regulation in hematopoiesis and its implications in the targeted therapy of hematologic malignancies.
   Zhao A, Zhou H, Yang J, Li M, et al · · 2023 · cited 81× · PMID 36797244 · DOI 10.1038/s41392-023-01342-6
3. T follicular helper phenotype predicts response to histone deacetylase inhibitors in relapsed/refractory peripheral T-cell lymphoma.
   Ghione P, Faruque P, Mehta-Shah N, Seshan V, et al · · 2020 · cited 81× · PMID 33002132 · DOI 10.1182/bloodadvances.2020002396
4. Histone Deacetylases (HDACs) Guided Novel Therapies for T-cell lymphomas.
   Zhang Q, Wang S, Chen J, Yu Z. · · 2019 · cited 72× · PMID 30911277 · DOI 10.7150/ijms.30154
5. Romidepsin for the Treatment of Peripheral T-Cell Lymphoma.
   Iyer SP, Foss FF. · · 2015 · cited 52× · PMID 26099743 · DOI 10.1634/theoncologist.2015-0043
6. Novel targeted therapies of T cell lymphomas.
   Iżykowska K, Rassek K, Korsak D, Przybylski GK, et al · · 2020 · cited 49× · PMID 33384022 · DOI 10.1186/s13045-020-01006-w
7. Use of class I histone deacetylase inhibitor romidepsin in combination regimens.
   Petrich A, Nabhan C. · · 2016 · cited 28× · PMID 27118119 · DOI 10.3109/10428194.2016.1160082
8. Epigenetic Therapy as a Putative Molecular Target to Modulate B Cell Biology and Behavior in the Context of Immunological Disorders.
   da Costa TP, El-Cheikh MC, Carneiro K. · · 2020 · cited 7× · PMID 32090127 · DOI 10.1155/2020/1589191