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Graft Versus Host DiseaseNCT02203578

Romidepsin in Treating Patients With Steroid-Refractory Graft-versus-Host Disease

A study testing romidepsin and laboratory biomarker analysis in people with Graft Versus Host Disease, run by Rutgers, The State University of New Jersey at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This pilot clinical trial studies romidepsin in treating patients with graft-versus-host disease (GVHD) that has not responded to treatment with steroids. Romidepsin may be an effective treatment for graft-versus-host disease caused by a bone marrow or stem cell transplant. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Graft Versus Host Disease
What is being tested?
romidepsin and laboratory biomarker analysis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
1 siteUnited States
Study dates
Nov 2014to 14 Jun 2016
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 steroid (or immunosuppressive therapy [IST]) refractory acute GVHD (aGVHD) or chronic GVHD (cGVHD)
  • Absolute neutrophil count >= 750/mm^3
  • Platelet count >= 50,000/mm^3
  • Corrected QT interval (QTc) =< 480 msec
  • Bilirubin =< 1.5 x upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x ULN
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  • Serum potassium >= 3.8 mmol/L
  • Serum magnesium >= 1.8 mg/dL
  • Serum creatinine =< 2.0 mg/dl
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-3
  • Patients may undergo electrolyte repletion therapy to meet eligibility requirements
  • Patients must be scheduled for tapering doses of (or no longer treated with):
  • Cyclosporine;
  • Tacrolimus;
  • Sirolimus;
  • Steroids (patients may be on physiologic doses of steroids)
  • Patients receiving extracorporeal photopheresis must discontinue extracorporeal photopheresis or placed on a tapering schedule;
  • Any prior therapy for GVHD must be completed and discontinued with the exception of the above;
  • Patients with breakpoint cluster region (bcr)-ABL proto-oncogene 1 (abl) associated malignancies may be on a tyrosine kinase inhibitor as malignant disease therapy or prophylaxis
  • There must be no uncontrolled active infections or medical conditions that the investigator feels will compromise the safety of the treatment and/or the assessment of the efficacy of therapy
  • The patient must be aware of the high risk and experimental nature of the treatment and provide informed consent
  • Negative serum pregnancy test at the time of enrollment for females of childbearing potential
  • For males and females of child-producing potential, use of effective contraceptive methods during the study and for at least 6 months after the last dose of romidepsin

Who cannot join

  • Active/uncontrolled infection
  • Evidence of relapsed disease
  • Life expectancy < 12 weeks
  • Pregnant or breast feeding females
  • Prior therapy with romidepsin
  • Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV); patients who are seropositive because of hepatitis B virus vaccine are eligible
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  • Any known cardiac abnormalities such as:
  • Congenital long QT syndrome
  • QTc interval >= 480 milliseconds;
  • Myocardial infarction within 6 months of course 1, day 1 (C1D1); subjects with a history of myocardial infarction between 6 and 12 months prior to C1D1 who are asymptomatic and have had a negative cardiac risk assessment (treadmill stress test, nuclear medicine stress test, or stress echocardiogram) since the event may participate;
  • Other significant electrocardiogram (ECG) abnormalities including 2nd degree atrio-ventricular (AV) block type II, 3rd degree AV block, or bradycardia (ventricular rate less than 50 beats/min);
  • 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;
  • Congestive heart failure (CHF) that meets New York Heart Association (NYHA) class II to IV definitions and/or ejection fraction < 40% by multi gated acquisition (MUGA) scan or < 50% by echocardiogram and/or magnetic resonance imaging (MRI);
  • A known history of sustained ventricular tachycardia (VT), ventricular fibrillation (VF), Torsade de Pointes, or cardiac arrest unless currently addressed with an automatic implantable cardioverter defibrillator (AICD);
  • Hypertrophic cardiomegaly or restrictive cardiomyopathy from prior treatment or other cause;
  • Any cardiac arrhythmia requiring an anti-arrhythmic medication (excluding stable doses of beta-blockers)
  • 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; or
  • Patients taking drugs leading to significant QT prolongation must have an ECG prior to each treatment
  • Concomitant use of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors
  • Concomitant use of medications known to induce a disulfiram-like reaction to alcohol

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

Other trials in United States

About this study

Official title: A Pilot Study of Romidepsin for Therapy of Graft-versus-Host Disease

This pilot clinical trial studies romidepsin in treating patients with graft-versus-host disease (GVHD) that has not responded to treatment with steroids. Romidepsin may be an effective treatment for graft-versus-host disease caused by a bone marrow or stem cell transplant.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine if romidepsin should be developed as a therapy for patients with steroid-refractory GVHD.

OUTLINE:

Patients receive romidepsin intravenously (IV) over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 3 and 6 months.

Being tested
romidepsin, laboratory biomarker analysis
Medical subject headings
Graft vs Host Disease

What participants receive

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

  • romidepsinDrug

    Also called FK228, FR901228, Istodax

    Given IV

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT02203578
Study groupRoleWhat they receive
Supportive care (romidepsin)ExperimentalPatients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Receives: Drug: romidepsin; Other: laboratory biomarker analysis

What is being measured

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

  1. Incidence of aGVHD

    Measured: At 28 days after initiation of romidepsin

  2. Incidence of cGVHD

    Measured: At 1 month after initiation of romidepsin

  3. Incidence of cGVHD

    Measured: At 3 months after initiation of romidepsin

  4. Incidence of cGVHD

    Measured: At 6 months after initiation of romidepsin

  5. Incidence of cGVHD

    Measured: At 9 months after initiation of romidepsin

  6. Incidence of cGVHD

    Measured: At 12 months after initiation of romidepsin

Secondary outcomes (3)

  1. Total Duration of Immunosuppressive Therapy

    Measured: Up to 12 months after initiation of romidepsin

  2. Rate of Documented Infection

    Measured: Up to 12 months after initiation of romidepsin

  3. T Cell Kinetics - Reconstitution

    Measured: Up to 12 months after initiation of romidepsin

Timeline

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

  1. First posted30 Jul 2014 (estimated)
  2. Study startNov 2014
  3. Primary completion14 Jun 2016
  4. Study completion14 Jun 2016

Why it stopped: slow accrual

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 N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02203578
Sponsor's protocol ID
021309
Other IDs
NCI-2014-01411, 021309, P30CA072720, Pro2014004116
Status last verified
Feb 2017
First submitted
28 Jul 2014
Last updated
30 Mar 2017
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing romidepsin and laboratory biomarker analysis in people with Graft Versus Host Disease, run by Rutgers, The State University of New Jersey at 1 site 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 23 inclusion and 21 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: stopped early, as of the sponsor's last update on 30 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Incidence of aGVHD (time frame: At 28 days after initiation of romidepsin). The study lists 6 primary outcomes in all. 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 NCT02203578.

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 30 Mar 2017.

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