MedTrace Logo

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

NCT01846390 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2026-03-27

No results posted yet for this study

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.

Conditions

  • Peripheral T-Cell Lymphoma
  • Diffuse Large B-Cell Lymphoma

Interventions

DRUG

Gemcitabine

Group 1 = 1000 mg/m2 D1, D8. Subsequent dose levels according to toxicity = 600-1000 mg/m2 D1, D15.

DRUG

Dexamethasone

40 mg D1 - D4

DRUG

Cisplatin

75 mg/m2 D1

DRUG

Romidepsin

Dose Level 0 - 6 mg/m2 D1, D8. Subsequent dose levels according to toxicity 6-14 mg/m2 D1, D15.

Sponsors & Collaborators

  • Celgene

    collaborator INDUSTRY

  • Canadian Cancer Trials Group

    lead NETWORK

Principal Investigators

  • Anthony J Reiman · Atlantic Health Sciences Corp - Saint John Regional Hospital, Saint John NB Canada

  • Kerry J Savage · BCCA Vancouver Cancer Centre, Vancouver BC Canada

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01846390 on ClinicalTrials.gov