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Peripheral T-Cell LymphomaPhase 1NCT01846390

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

A Phase 1 study testing Gemcitabine, Dexamethasone and Cisplatin in people with Peripheral T-Cell Lymphoma and Diffuse Large B-Cell Lymphoma, run by Canadian Cancer Trials Group at 6 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Gemcitabine, Dexamethasone and Cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
6 sitesCanada
Study dates
1 Oct 2013to 19 Sep 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with histologically confirmed PTCL. Biopsy proof of disease at initial diagnosis is mandatory. A biopsy at relapse is preferred but not mandatory.
  • Patients must have received one or two previous regimens of therapy for their disease (salvage chemotherapy plus autologous stem cell transplantation is considered to be one regimen).
  • Clinically and / or radiologically measurable disease (1 site bidimensionally measurable). Measurements / evaluations must be done within 28 days prior to registration.
  • Age 18 to 75 years.
  • ECOG performance status 0, 1 or 2.
  • Life expectancy of ≥ 90 days (3 months).
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  • Laboratory Requirements: (must be done within 7 days of registration)
  • Hematology:
  • Granulocytes (AGC) ≥ 1.0 x 10^9/L
  • Platelets ≥ 75 x 10^9/L (≥ 50 if bone marrow involvement by lymphoma)
  • Biochemistry:
  • AST and ALT ≤ 2.5x ULN (≤ 5x ULN if hepatic involvement of disease)
  • Serum total bilirubin ≤ 1.5x ULN (≤ 3x ULN if hepatic involvement of disease, or ≤5x ULN if Gilberts Disease)
  • Serum Potassium ≥ 3.8 mmol/L*
  • Serum Magnesium ≥ 0.85 mmol/L* * NB: Patients with potassium and magnesium levels below these values are eligible if supplementation has corrected these deficits. This supplementation should continue throughout the course of the study.
  • Calculated creatinine clearance (Cockcroft-Gault formula) of ≥ 50 mL /min.
  • Women must be post-menopausal, surgically sterile or use reliable forms of contraception while on study and for 90 days after discontinuing therapy. Women of childbearing potential must have a pregnancy test taken and proven negative within 7 days prior to registration and must not be lactating.
  • Patient consent must be obtained according to local Institutional and/or University Human Experimentation Committee requirements.
  • Patients must be accessible for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating centre. This implies there must be reasonable geographical limits (for example: 1 ½ hour's driving distance) placed on patients being considered for this trial.
  • In accordance with NCIC CTG policy, protocol treatment is to begin within 2 working days of patient registration.

Who cannot join

  • Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer and superficial bladder cancer, curatively treated in-situ cancer of the cervix or breast or localized excised prostate cancer, or other solid tumours curatively treated with no evidence of disease for ≥ 3 years.
  • Central nervous system involvement, meningeal or parenchymal. Patients with CNS disease at initial presentation and who are in a CNS CR at the time of relapse are eligible. MRI scanning and / or lumbar puncture should be performed if there is clinical suspicion of active CNS disease.
  • HIV, active hepatitis B or current hepatitis C infection. (Hepatitis B core antibody positive, surface antigen negative patients allowed if concurrent anti-viral prophylaxis is administered. Patients with a past history of hepatitis C who have eradicated the virus are eligible.)
  • Any serious active disease or co-morbid medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from participating (according to investigator's decision).
  • Patients with serious cardiac illness or condition including, but not limited to:
  • history of documented congestive heart failure (CHF)
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  • systolic dysfunction (LVEF < 45% by MUGA or ECHO)
  • high risk uncontrolled arrhythmias (ventricular tachycardia, high-grade AV-block, supraventricular arrhythmias which are not adequately rate-controlled)
  • unstable angina pectoris requiring anti-anginal medication
  • clinically significant valvular heart disease
  • evidence of transmural infarction on ECG
  • New York Heart Association (NYHA) Class III or IV functional status
  • patients with congenital long QT syndrome, history of significant cardiovascular disease and/or taking drugs leading to significant QT prolongation
  • patients with QTc > 480 msec are not eligible
  • Pregnant or lactating females or women of childbearing potential not willing to use an adequate method of birth control for the duration of the study.
  • Patients with active or uncontrolled infections, or with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol are not eligible.
  • Patients are not eligible if they have a known hypersensitivity to the study drugs or their components.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Canada6 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • QEII Health Sciences Centre

    Halifax, Nova Scotia, B3H 1V7

  • Regional Health Authority B, Zone 2

    Saint John, New Brunswick, E2L 4L2

  • Odette Cancer Centre

    Toronto, Ontario, M4N 3M5

  • Univ. Health Network-Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • BCCA - Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

About this study

Official title: 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

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.

Read the detailed description

The purpose of this study is to find the highest dose of romidepsin that can safely be given in combination with gemcitabine, dexamethasone, and cisplatin (GDP) without causing very severe side effects that are not tolerable. This is done by starting at a dose lower than the one that does not cause side effects in animals. Patients are given romidepsin and GDP and watched very closely to see what side effects they have and to make sure the side effects are not severe. If the side effects are not severe, then more patients are asked to join the study and are given a higher dose of romidepsin (with GDP). Patients joining the study later on will get higher doses of romidepsin (with GDP) than patients who join earlier. This will continue until a dose is found that causes severe but temporary side effects. Doses higher than that will not be given.

Being tested
Gemcitabine, Dexamethasone, Cisplatin, Romidepsin
Medical subject headings
Lymphoma, T-Cell, Peripheral, Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GemcitabineDrug

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

  • DexamethasoneDrug

    40 mg D1 - D4

  • CisplatinDrug

    75 mg/m2 D1

  • RomidepsinDrug

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

Study groups in NCT01846390
Study groupRoleWhat they receive
romidepsin, gemcitabine, dexamethasone and cisplatinExperimentalA traditional phase I dose escalation design is proposed to assess the feasibility and tolerability of romidepsin in combination with GDP, where treatment will be escalated. Treatment will be given for 6 cycles unless there is evidence of progression prior to completion of the 6 cycles or tolerability to the regimen is not sustained.
Receives: Drug: Gemcitabine; Drug: Dexamethasone; Drug: Cisplatin; Drug: Romidepsin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerated dose of combined romidepsin, gemcitabine, dexamethasone and cisplatin.

    Combination of GDP with romidepsin at the maximum tolerated doses of these agents will identify the combination regimen for comparison in the subsequent randomized phase II trial; if romidepsin appears to improve the activity of GDP, then this will move forward to a formal phase III comparison to CHOP.

    Primary end points are toxicity, the maximum administered dose and the recommended phase II dose.

    Measured: 48 months

Secondary outcomes (1)

  1. Number of patients with adverse events

    Adverse events by grade, dose level and total incidence; vital signs will be summarized and DLTs reported separately

    Measured: 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2013 (estimated)
  2. Study start1 Oct 2013
  3. Primary completion6 Jul 2016
  4. Study completion19 Sep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01846390
Sponsor's protocol ID
LY15
Status last verified
Nov 2019
First submitted
1 May 2013
Last updated
27 Mar 2026
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 30301414

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Gemcitabine, Dexamethasone and Cisplatin in people with Peripheral T-Cell Lymphoma and Diffuse Large B-Cell Lymphoma, run by Canadian Cancer Trials Group at 6 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose of combined romidepsin, gemcitabine, dexamethasone and cisplatin. (time frame: 48 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01846390, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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