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

NCT01500538 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2016-02-15

No results posted yet for this study

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.

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.

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.

Conditions

Interventions

DRUG

Eltrombopag and 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)

Sponsors & Collaborators

Principal Investigators

  • Michael Dickinson, MBBS (Hons), FRCPA · Peter MacCallum Cancer Centre, Australia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2013-05-31
Completion
2014-05-31

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT01500538 on ClinicalTrials.gov