NCT00865969 · REGISTRY CONDITION SEARCH

Belinostat in Relapsed or Refractory Peripheral T-Cell Lymphoma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2021-10-29

The purpose of this study is to assess efficacy and safety of belinostat in participants with relapsed or refractory peripheral T-cell lymphoma (PTCL), who failed at least one prior systemic therapy.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Objective Response Rate

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outcome · POSTED

Time to Response

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outcome · POSTED

Duration of Response

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outcome · POSTED

Time to Progression

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outcome · POSTED

Progression Free Survival

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outcome · POSTED

Overall Survival

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outcome · POSTED

Number of Participants With At Least One Serious Treatment-Emergent Adverse Event (TEAE)

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outcome · NOT POSTED

Population Pharmacokinetics

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion criteria: * A histologically confirmed diagnosis of PTCL * Participants must have relapsed or refractory disease after at least one prior systemic anticancer regimen. Systemic anticancer therapy is defined as chemotherapy or immunotherapy administered systemically. * Participants must have at least one site of disease measurable in two dimensions by computed tomography (CT). * Age ≥ 18 years. * Adequate bone marrow, liver, and renal functions. * Eastern Cooperative Oncology Group (ECOG) performance status 0-2. * Negative pregnancy test for women of childbearing potential. Exclusion criteria: * Relapse within 100 days of autologous or allogeneic bone marrow transplant. * Prior histone deacetylase (HDAC) inhibitor therapy. * Co-existing active infection or any medical condition likely to interfere with trial procedures. * Severe cardiovascular disease. * Clinically significant central nervous system disorders with altered mental status or psychiatric disorders precluding understanding of the informed consent process and/or completion of the necessary studies. * Active concurrent malignancy (except adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix). * Symptomatic or untreated central nervous system (CNS) metastases. * Pregnant or breast-feeding women. * Known infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C.
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Belinostat 1000 mg/m\^2 administered as a 30 minute IV infusion on Days 1-5 of every 3-week cycle until disease progression or unmanageable treatment-related toxicities.
intervention Names
Drug: Belinostat
label
Belinostat
type
EXPERIMENTAL

interventions

arm Group Labels
Belinostat
name
Belinostat
other Names
PXD101
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 129
type: ACTUAL

Registered outcome plans (not posted results)

other Outcomes

measure
Population Pharmacokinetics
time Frame
24 months

primary Outcomes

description
Objective response rate was defined as the percentage of participants with a complete response (CR) or a partial response (PR) according to International Working Group (IWG) criteria. The response was assessed based on clinical and radiological criteria. CR is defined as the disappearance of all evidence of disease. PR is defined as a regression of measurable disease and no new sites. As pre-defined, the primary endpoint analysis for this study was based on the Independent Review Committee (IRC) assessment of response.
measure
Objective Response Rate
time Frame
24 months

secondary Outcomes

description
Time to response was defined as the time (in weeks) from first administration of treatment until first response. Response is defined as complete response (CR) or partial response (PR). CR is defined as the disappearance of all evidence of disease. PR is defined as a regression of measurable disease and no new sites.
measure
Time to Response
time Frame
24 months
description
The Duration of Response was assessed by IWG criteria per the IRC from the date the measurement criteria were first met for CR or PR (whichever status was recorded first) until the first subsequent date that relapse or progression was documented. It was estimated by the Kaplan-Meier method. Response is defined as complete response (CR) or partial response (PR). CR is defined as the disappearance of all evidence of disease. PR is defined as a regression of measurable disease and no new sites.
measure
Duration of Response
time Frame
24 months
description
Time to progression was defined as the time (in months) from first administration of treatment to the date of disease progression based on tumor assessments made according to the IWG criteria as assessed by the IRC. The progression is defined as any new lesion or increase by ≥ 50% of previously involved sites from nadir.
measure
Time to Progression
time Frame
24 months
description
Progression-free survival (PFS) was the duration of time from first administration of study treatment to date of first documented progression or death from any cause. It was based on tumor assessments made according to the IWG criteria as assessed by the IRC. The progression is defined as any new lesion or increase by ≥ 50% of previously involved sites from nadir.
measure
Progression Free Survival
time Frame
24 months
description
Overall Survival was the time from first administration of study treatment until the date of death.
measure
Overall Survival
time Frame
24 months
description
A TEAE was defined as an event with an onset date and time on or after the first dosing start date and time, or on or after the first dosing start date if the onset time was missing. A serious TEAE was any untoward medical occurrence that at any dose results in death, prolonged hospitalization, persistent or significant disability or congenital abnormalities.
measure
Number of Participants With At Least One Serious Treatment-Emergent Adverse Event (TEAE)
time Frame
24 months

Full study description

brief Summary: The purpose of this study is to assess efficacy and safety of belinostat in participants with relapsed or refractory peripheral T-cell lymphoma (PTCL), who failed at least one prior systemic therapy.
detailed Description: This is an open-label, multicenter, single arm efficacy and safety study in participants with relapsed or refractory peripheral T-cell lymphoma, who have failed at least one prior systemic therapy. Approximately 120 participants will be enrolled. Participants will be treated with 1000 mg/m\^2 belinostat administered as a 30-minute IV infusion on Days 1-5 of every 3-week cycle until there is disease progression or unmanageable treatment-related toxicities. The primary study endpoint is objective response rate (ORR) based on the International Harmonization Project (IHP) revision International Working Group (IWG) criteria. Safety will be evaluated during the study and for 30 days after the last administration of study drug. Adverse events and laboratory studies will be graded according to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) v. 3.0.

Source references

references

citation
Campbell P, Thomas CM. Belinostat for the treatment of relapsed or refractory peripheral T-cell lymphoma. J Oncol Pharm Pract. 2017 Mar;23(2):143-147. doi: 10.1177/1078155216634178. Epub 2016 Jun 23.
pmid
26921086
type
RESULT

Source notices and limitations

Discovery and provenance

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source kind
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source url
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Preserved source evidence · Not medical advice