Phase 1 Dose Finding Study of Belinostat for Treatment of Patients With Peripheral T-cell Lymphoma (PTCL)
Study type: Interventional What is this?
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase: I What is this?
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
- Rochester, Minnesota: 13-005584
NCT ID: NCT01839097
Sponsor Protocol Number: SPI-BEL-12-104
About this study
The primary objective of this study is to determine the Maximum Tolerated Dose (MTD) for belinostat when combined with CHOP regimen and establish the recommended belinostat dose for the Phase 3 study.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.
See eligibility criteria
- Age 18 years or above
- Life Expectancy > 3 months
- Histologically confirmed diagnosis of PTCL
- Patients with transformed CTCL eligible for CHOP regimen
- Measurable disease based on Cheson 2007 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status < 2
- Known active Hepatitis B/ Hepatitis C/ HIV infection
- Known, uncontrolled CNS metastases or primary CNS lymphoma
- Deep vein thrombosis diagnosed within 3 months
- Ongoing treatment for pre-existing cardiovascular disease
- Neuropathy Grade 3 or more
- Previous extensive radiotherapy except limited field RT for locally advanced nasal NK PTCL or for pain palliation
- Prior therapy with severely myelotoxic regimens, including autologous and allogenic stem cell transplantation
- Prior therapy with HDAC inhibitors (except for CTCL)
- Inadequate hematological, hepatic, or renal function
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.
|Mayo Clinic Location
Mayo Clinic principal investigator
Patrick Johnston, M.D., Ph.D.
Open for enrollment
Cancer Center Clinical Trials Referral Office