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Follicular LymphomaPhase 2VEILNCT01500538

A Pilot Study of Oral Vorinostat Plus Oral Eltrombopag Support in Patients With Lymphoma (VEIL)

A Phase 2 study testing Eltrombopag and Vorinostat in people with Follicular Lymphoma and Marginal Zone Lymphoma, run by Peter MacCallum Cancer Centre, Australia at 1 site in Australia.

Terminated

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

Official record
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Trial summary

Vorinostat is a drug (Histone Deacetylase Inhibitor [HDACi]) administered orally that has been approved in United States for the patients with cutaneous Tcell lymphoma (CTCL) who have progressive, persistent or recurrent disease on or following two systemic therapies. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Eltrombopag and Vorinostat
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
1 siteAustralia
Study dates
Oct 2012to May 2014
Phase
Phase 2
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

  • Age 18years or older
  • T-cell lymphoma involving the skin or patients with relapsed/refractory follicular lymphoma (FL), marginal zone lymphoma (MZL), or mantle cell lymphoma (MCL). Disease must have been confirmed by previous histology and must be measurable
  • For patients with cutaneous T-cell lymphoma: At least 2 prior systemic therapies (including 1 month of therapy with systemic steroids >25mg alternating days of prednisolone or equivalent, or total skin electron-beam radiotherapy). For patients with B cell lymphoma, prior exposure to a chemotherapy regimen is required, unless the patient is deemed to be unfit for conventional chemo-therapeutic regimens.
  • Adequate haematological function: ANC ≥ 1.0x109/L
  • Adequate renal function (serum creatinine clearance calculated as CrCl ≥30mL/min (perform 24hr urine creatinine clearance if serum creatinine is >1.5xULN);electrolyte levels ≥ LLN (i.e.: potassium, total calcium [corrected for serum albumin], magnesium and phosphorus) or correctable with supplements)
  • Adequate hepatic function:AST and ALT ≤ 2.5 x ULN (or ≤ 5.0 x ULN if liver infiltration;Serum bilirubin ≤ 1.5 x ULN
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  • Life expectancy ≥ 12 weeks
  • Written informed consent obtained prior to any study specific screening procedures
  • ECOG performance status grade 0-2
  • Ability to comply with adequate contraception in patients of childbearing potential.
  • Females of childbearing potential must have had a negative urine pregnancy test at screening and agree to use a medically reliable method of preventing conception throughout the study and for 30 days following the date of last dose.
  • Males with a female partner of childbearing potential must agree to use a medically reliable method of preventing conception throughout the study and for 30 days following the date of last dose.
  • Mentally competent and is able to understand the information given and provide informed consent.

Who cannot join

  • Known uncontrolled medical conditions which may compromise participation in this study including but not limited to:Poorly controlled congestive heart failure: ejection fraction <30% measured in past 6 months) or NYHA class IV;Unstable angina or an ischaemic cardiac event requiring hospital admission in the previous 12 months.
  • Concomitant use of another HDAC inhibitor, including sodium valproate.
  • GI disease that may significantly alter the absorption of eltrombopag
  • Subjects known to be seropositive for HIV, Hepatitis B or Hepatitis C.
  • Current participation in other trials or studies of medical therapeutic interventions.
  • Known pro-thrombotic condition as defined by a history ≥1 unprovoked deep venous thrombosis or pulmonary embolism, or any DVT/PE with a procoagulant condition screen suggesting the presence of a procoagulant condition (prothrombin gene mutation homozygosity, factor V Leiden homozygosity, antithrombin deficiency, lupus anticoagulant syndrome).
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  • History of ischaemic neurological event (TIA or stroke) within the preceding 2 years.
  • Active or uncontrolled infection, other than cutaneous infection.
  • Prior diagnosis of cancer that was:more than 5 years prior to current diagnosis with subsequent evidence of disease recurrence or estimated clinical expectation of recurrence is greater than 10% within next 2 years;within 5 years of current diagnosis with the exception of successfully treated basal cell or squamous cell skin carcinoma, carcinoma in situ of the cervix or localised cancer treated curatively with local therapy only
  • Use of another anti-cancer treatment within 21 days of starting vorinostat, with the exception of steroids, interferon or oral methotrexate which have been at a stable dose for at least 4 weeks prior to day 1.

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3002

Other trials in Australia

About this study

Vorinostat is a drug (Histone Deacetylase Inhibitor [HDACi]) administered orally that has been approved in United States for the patients with cutaneous Tcell lymphoma (CTCL) who have progressive, persistent or recurrent disease on or following two systemic therapies.

In the early period of treatment with vorinostat, some patients may experience low platelet counts. Therefore this study will be examining the combination of these two medications (Vorinostat and eltrombopag) to assess if eltrombopag can overcome the low platelets during treatment with vorinostat.

Read more

Eltrombopag is a drug administered orally designed to mimic the protein thrombopoietin, which causes the body to make more platelets. Eltrombopag has been registered in Australia and approved overseas to treat patients with chronic ITP (Immune Thrombocytopenia Purpura) a disease where patients destroy their own platelets very rapidly and thus develop low platelet count) but it is not registered and it is not yet known whether eltrombopag can increase platelet counts in patients treated with the HDACi.

The aim of this project is to test whether Vorinostat and eltrombopag can be safely combined, and to test whether they are effective in participants with T-cell lymphoma involving the skin or patients with relapsed/refractory follicular lymphoma (FL), marginal zone lymphoma (MZL), or mantle cell lymphoma (MCL)

A total of 25 people with Cutaneous T cell lymphoma/ CTCL, marginal zone lymphoma, follicular lymphoma or mantle cell lymphoma will be recruited in this study.

Being tested
Eltrombopag and Vorinostat
Keywords
Follicular lymphoma, Marginal zone lymphoma, Mantle cell lymphoma, thrombocytopenia, eltrombopag, vorinostat, lymphoma
Medical subject headings
Lymphoma, Follicular, Lymphoma, B-Cell, Marginal Zone, Lymphoma, Mantle-Cell, Thrombocytopenia, Lymphoma

What participants receive

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

  • Eltrombopag and VorinostatDrug

    Also called Revolade (eltrombopag), Zolinza (vorinostat)

    4 week mono-therapy eltrombopag, commencing at 50mg/day, increasing to 200mg. Daily intake of 400mg vorinostat for minimum of 6 cycles, each cycle of 4 weeks, possibly in combination with daily intake eltrombopag commencing at 50mg/day at a maximum dose of 200md/day (150mg/day for subjects of East-Asian ancestry)

Study groups in NCT01500538
Study groupRoleWhat they receive
Eltrombopag and vorinostat combination therapyExperimentalDaily oral intake of 400mg vorinostat if necessary with combination therapy eltrombopag commencing at 50mg per day increasing to a maximum of 200mg per day
Receives: Drug: Eltrombopag and Vorinostat

What is being measured

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

  1. The occurrence of all grade III/IV adverse events (haematological and non haematological) during vorinostat and eltrombopag combination therapy

    The period of observation for the primary endpoint is defined as the observation for 6 cycles of eligible patients who have commencement eltrombopag following commencement of vorinostat.

    Measured: One year from trial entry

Secondary outcomes (1)

  1. Occurrence of thrombocytopenia (TCP) with vorinostat therapy and response to eltrombopag: platelet, transfusion and bleeding endpoints

    Occurrence \& severity of thrombocytopenia (TCP), all grades at baseline \& during first 6 vorinostat cycles.

    Occurrence \& severity of worsening grade of TCP (relative to day 1 cycle 1 of vorinostat therapy) after cycle 1 day 8.

    Occurrence \& severity of TCP following withdrawal of eltrombopag in patients who had protocol-specified withdrawal of eltrombopag.

    Occurrence of platelet response, defined as a cycle nadir platelet count showing a 50% improvement in platelet nadir compared to previous cycle \& at least an absolute increase of 20x109/L.

    Occurrence of grade III/IV TCP during vorinostat treatment cycle among patients who experience a platelet nadir ≤25 x109/L, receive eltrombopag \& who then achieve a platelet response.

    Percentage drop in platelet count from day 1 of cycle to nadir \& percentage drop in neutrophil count from day 1 of cycle to nadir, for each cycle.

    Occurrence \& severity of clinically significant bleeding events defined as per the WHO bleeding scale.

    Measured: One year from trial entry

Timeline

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

  1. First posted28 Dec 2011 (estimated)
  2. Study startOct 2012
  3. Primary completionMay 2013
  4. Study completionMay 2014

Why it stopped: Poor recruitment rate

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01500538
Sponsor's protocol ID
11/111
Acronym
VEIL
Status last verified
Oct 2012
First submitted
22 Dec 2011
Last updated
15 Feb 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Eltrombopag and Vorinostat in people with Follicular Lymphoma and Marginal Zone Lymphoma, run by Peter MacCallum Cancer Centre, Australia at 1 site in Australia.

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 13 inclusion and 10 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 15 Feb 2016. 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 Australia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 was stopped early (reason given: Poor recruitment rate). Results are not available in the source record.

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?

The occurrence of all grade III/IV adverse events (haematological and non haematological) during vorinostat and eltrombopag combination therapy (time frame: One year from trial entry). 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 NCT01500538.

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 15 Feb 2016.

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