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Lymphoma, T-Cell, CutaneousPhase 1NCT02181218

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

A Phase 1 study testing Romidepsin, Gemcitabine and Oxaliplatin in people with Lymphoma, T-Cell, Cutaneous and Lymphoma, T-Cell, Peripheral, run by Washington University School of Medicine at 2 sites in United States.

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

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Romidepsin, Gemcitabine and Oxaliplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
2 sitesUnited States
Study dates
4 Feb 2015to 26 Jun 2020
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

  • Able to understand and voluntarily sign an informed consent form
  • Age ≥ 18 at time of informed consent
  • Diagnosis of one of the following:
  • relapsed/refractory peripheral T-cell lymphoma of any subtype including mycosis fungoides and Sézary syndrome of advanced stage (IIB-IVB)
  • for the expansion cohort:patients must have biopsy-proven T-cell lymphoma and measurable disease.
  • relapsed/refractory DLBCL (up to 6 DLBCL patients are allowed in the dose-escalation portion of the study)
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  • relapsed/refractory HL
  • Note: extracorporeal photopheresis is NOT considered a systemic therapy for this study.
  • Transplant eligible (as determined by referring physician) patients who have failed one prior salvage therapy or transplant ineligible (as determined by referring physician) patients who have failed one prior therapy
  • ECOG performance status of ≤ 2
  • Laboratory test results within the following ranges:
  • Absolute neutrophil count ≥ 1500/mm³
  • Platelet count ≥ 100,000/mm³
  • Total bilirubin ≤ 1.5 x ULN
  • AST (SGOT) and ALT (SGPT) ≤ 3 x ULN
  • Creatinine < 2 mg/dL
  • Potassium ≥ 3.3 mmol/L or at/above the lower limit of normal for the performing laboratory
  • Magnesium ≥ 1.4 mg/dL or at/above the lower limit of normal for the performing laboratory.
  • Negative serum pregnancy test for women of childbearing potential
  • Washout time of at least 4 weeks for prior biological, chemotherapeutic, or radiotherapy

Who cannot join

  • Any serious medical condition, laboratory abnormality, or psychiatric illness that would - in the opinion of the investigator - prevent the subject from signing the informed consent form
  • Pregnant or lactating women
  • Any medical condition or laboratory abnormalities, which - in the opinion of the investigator - places the subject at unacceptable risk, or confounds the ability to interpret data if he/she were to participate in the study
  • Positive CSF cytology during staging, symptomatic leptomeningeal involvement, or parenchymal involvement of brain or spinal cord
  • Prior allogeneic hematopoietic cell transplant
  • Prior solid organ transplant
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  • Cirrhotic liver disease from any cause
  • Known HIV infection
  • Impaired cardiac function or clinically significant cardiac disease including any of the following:
  • Congenital long QT syndrome
  • Screening ECG with QTc interval ≥ 500 milliseconds
  • Myocardial infarction (MI) or unstable angina ≤ 6 months of C1D1; however, subjects with a history of MI between 6 and 12 months who are asymptomatic and have had a negative cardiac risk assessment (treadmill stress test, nuclear medicine stress test, or stress echocardiogram) since the event would be eligible
  • Symptomatic coronary artery disease (CAD), e.g., angina Canadian Class II-IV. In any patient in whom there is doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not CAD is present
  • An ECG recorded at screening showing evidence of cardiac ischemia (ST depression of ≥2 mm, measured from isoelectric line to the ST segment). If in any doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not CAD is present
  • Other significant ECG abnormalities including 2nd degree atrio-ventricular (AV) block type II, 3rd degree AV block, or bradycardia (defined here as ventricular rate < 50 bpm); right bundle-branch block + left anterior hemi-block (bifasicular block)
  • Congestive heart failure (CHF) that meets New York Heart Association (NYHA) Class II to IV definitions (see Appendix 9) and/or ejection fraction <40% by MUGA scan or <50% by echocardiogram and/or MRI History or presence of sustained ventricular tachycardia (VT), ventricular fibrillation (VF), torsade de pointes, or cardiac arrest
  • Hypertrophic cardiomegaly or restrictive cardiomyopathy from prior treatment or other causes
  • Uncontrolled hypertension, i.e., blood pressure (BP) of ≥160/95; patients who have a history of hypertension controlled by medication must be on a stable dose (for at least one month) and meet all other inclusion criteria
  • Any cardiac arrhythmia requiring an anti-arrhythmic medication, excluding stable (i.e., at least 30 days from screening) doses of beta-blockers
  • Concomitant use of drugs that may cause significant QT prolongation and/or torsades de pointes that cannot be discontinued or switched to a different medication prior to treatment
  • Concomitant use of CYP3A4 inhibitors or inducers unless able to stop medication(s) prior to starting study treatment
  • Patients who are unwilling to stop the use of herbal remedies while receiving study treatment
  • Unable to accept blood product transfusions
  • Men whose sexual partners are women of childbearing potential not using a double method of contraception during the study and 3 months after the end of treatment. One of these methods must be a condom
  • Concurrent malignancy requiring active therapy *Patients with localized prostate cancer having undergone surgery or radiation (field confined to ≤ 30% of marrow-bearing bone) at least 30 days prior to study treatment are eligible

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Chicago

    Chicago, Illinois, 60637

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: A Multicenter Phase I Dose-finding and Preliminary Efficacy Study of the Histone Deacetylase Inhibitor Romidepsin (Istodax) in Combination With Gemcitabine (Gemzar), Oxaliplatin (Eloxatin), and Dexamethasone for the Treatment of Adults With Relapsed/Refractory Aggressive Lymphomas

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.

Medical subject headings
Lymphoma, T-Cell, Cutaneous, Lymphoma, T-Cell, Peripheral, Hodgkin Disease, Lymphoma, Large B-Cell, Diffuse

What participants receive

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

Study groups in NCT02181218
Study groupRoleWhat they receive
Dose Level 0 (starting dose) (8 mg/m2 romidepsin)Experimental* Romidepsin will be administered intravenously (IV) over 2 hours on Days 2 and 8; * Gemcitabine IV over 30 minutes on Day 1 * Oxaliplatin IV over 2 hours on Day 1 * Dexamethasone orally on Days 1-4 * Pegfilgrastim subcutaneously on Day 3 * Drugs may be administered in any order on Day 1. * Each cycle is 21 days. * May continue on therapy for up to 8 cycles total if achieving adequate disease control (CR, PR, or stable disease) and without significant toxicity
Receives: Drug: Romidepsin; Drug: Gemcitabine; Drug: Oxaliplatin; Drug: Dexamethasone; Drug: Pegfilgrastim
Dose Level 1 (10 mg/m2 romidepsin)Experimental* Romidepsin will be administered intravenously (IV) over 2 hours on Days 2 and 8; * Gemcitabine IV over 30 minutes on Day 1 * Oxaliplatin IV over 2 hours on Day 1 * Dexamethasone orally on Days 1-4 * Pegfilgrastim subcutaneously on Day 3 * Drugs may be administered in any order on Day 1. * Each cycle is 21 days. * May continue on therapy for up to 8 cycles total if achieving adequate disease control (CR, PR, or stable disease) and without significant toxicity
Receives: Drug: Romidepsin; Drug: Gemcitabine; Drug: Oxaliplatin; Drug: Dexamethasone; Drug: Pegfilgrastim
Dose Level 2 (12 mg/m2 romidepsin)Experimental* Romidepsin will be administered intravenously (IV) over 2 hours on Days 2 and 8; * Gemcitabine IV over 30 minutes on Day 1 * Oxaliplatin IV over 2 hours on Day 1 * Dexamethasone orally on Days 1-4 * Pegfilgrastim subcutaneously on Day 3 * Drugs may be administered in any order on Day 1. * Each cycle is 21 days. * May continue on therapy for up to 8 cycles total if achieving adequate disease control (CR, PR, or stable disease) and without significant toxicity
Receives: Drug: Romidepsin; Drug: Gemcitabine; Drug: Oxaliplatin; Drug: Dexamethasone; Drug: Pegfilgrastim

What is being measured

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

  1. Maximum tolerated dose (recommended Phase II dose)

    Three participants will be treated at each dose level. If 0/3 patients experience dose limiting toxicity (DLT), 3 patients will be treated at the next dose level. If a DLT attributable to the treatment is experienced in 1 of 3 patients, three more patients (for a total of six participants) will be treated at that dose level. If no additional DLTs are observed at the expanded dose level (i.e. 1 of 6 with DLT), the dose will be escalated. Escalation will terminate as soon as two or more participants experience any DLT attributable to study combination, at a given dose level. If 2 or more DLTs occur at the starting dose level, a decreased dose level will be explored at dose level -1.

    There will be no more than 2 patients dosed for the first time within the same week, and patients in the next higher cohorts will not be enrolled until the last patient of the lower cohort has completed the DLT monitoring period, defined as 21 days after first dose of Cycle 1 therapy.

    Measured: 37 months (completion of first cycle of all participants in study)

Secondary outcomes (5)

  1. Complete response rate

    For study participants with relapsed/refractory peripheral T-cell lymphoma (PTCL), diffuse large b-cell lymphoma (DLBCL), and Hodgkin's lymphoma response will be assessed in accordance with the updated International Working Group (IWG) recommendations.

    For study participants with cutaneous t-cell lymphoma (CTCL), the Global Response Score established by the ISCL/USCLC/EORTC consensus panel will be used to assess response to treatment.

    Measured: Up to 1 year from time of maximal response

  2. Partial response rate

    For study participants with relapsed/refractory peripheral T-cell lymphoma (PTCL), diffuse large b-cell lymphoma (DLBCL), and Hodgkin's lymphoma response will be assessed in accordance with the updated International Working Group (IWG) recommendations.

    For study participants with cutaneous t-cell lymphoma (CTCL), the Global Response Score established by the ISCL/USCLC/EORTC consensus panel will be used to assess response to treatment.

    Measured: Up to 1 year from time of maximal response

  3. Overall response rate

    For study participants with relapsed/refractory peripheral T-cell lymphoma (PTCL), diffuse large b-cell lymphoma (DLBCL), and Hodgkin's lymphoma response will be assessed in accordance with the updated International Working Group (IWG) recommendations.

    For study participants with cutaneous t-cell lymphoma (CTCL), the Global Response Score established by the ISCL/USCLC/EORTC consensus panel will be used to assess response to treatment.

    Overall response rate = complete response + partial response

    Measured: Up to 1 year from time of maximal response

  4. Progression free survival

    Progression-free survival (PFS) will be defined as the time from registration until disease progression.

    Measured: Up to 1 year from time of maximal response

  5. Duration of response

    Measured: Up to 1 year from time of maximal response

Timeline

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

  1. First posted3 Jul 2014 (estimated)
  2. Study start4 Feb 2015
  3. Primary completion28 Mar 2019
  4. Study completion26 Jun 2020

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02181218
Sponsor's protocol ID
201407160
Status last verified
Nov 2020
First submitted
1 Jul 2014
Last updated
17 Nov 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Foley N, Riedell PA, Bartlett NL, Cashen AF, Kahl BS, Fehniger TA, Fischer A, Moreno C, Liu J, Carson KR, Mehta-Shah N. A Phase I Study of Romidepsin in Combination With Gemcitabine, Oxaliplatin, and Dexamethasone in Patients With Relapsed or Refractory Aggressive Lymphomas Enriched for T-Cell Lymphomas. Clin Lymphoma Myeloma Leuk. 2025 May;25(5):328-336. doi: 10.1016/j.clml.2024.11.015. Epub 2024 Dec 4.

    PubMed 39725584

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Romidepsin, Gemcitabine and Oxaliplatin in people with Lymphoma, T-Cell, Cutaneous and Lymphoma, T-Cell, Peripheral, run by Washington University School of Medicine at 2 sites in United States.

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 25 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 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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 (recommended Phase II dose) (time frame: 37 months (completion of first cycle of all participants in study)). 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 NCT02181218, 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 17 Nov 2020.

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