A Phase 2 interventional study of Belinostat in Peripheral T-cell Lymphoma, sponsored by Spectrum Pharmaceuticals, Inc. Completed at 117 sites in 17 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-29.
Sponsored by Spectrum Pharmaceuticals, Inc · Phase 2, Interventional, and Treatment
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.
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.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 129 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Spectrum Pharmaceuticals, Inc is the lead sponsor of 59 studies on the registry; 1 is open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 12 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
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.
Drug: Belinostat
Also known as: PXD101
Objective Response Rate
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.
Time frame: 24 months
Time to Response
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.
Time frame: 24 months
Duration of Response
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.
Time frame: 24 months
Time to Progression
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.
Time frame: 24 months
Progression Free Survival
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.
Time frame: 24 months
Overall Survival
Overall Survival was the time from first administration of study treatment until the date of death.
Time frame: 24 months
Number of Participants With At Least One Serious Treatment-Emergent Adverse Event (TEAE)
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.
Time frame: 24 months
Population Pharmacokinetics
Time frame: 24 months
| Milestone | Belinostat |
|---|---|
| Started | 129 |
| Completed | 129 |
| Not completed | 0 |
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.
| percentage of participants | Belinostat |
|---|---|
| Objective Response Rate | 25.8 (18.3 to 34.6) |
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.
| weeks | Belinostat |
|---|---|
| Time to Response | 5.6 (4.3 to 50.4) |
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.
| months | Belinostat |
|---|---|
| Duration of Response | 13.6 (4.5 to 29.4) |
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.
| months | Belinostat |
|---|---|
| Time to Progression | 2 (1.5 to 2.9) |
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.
| months | Belinostat |
|---|---|
| Progression Free Survival | 1.6 (1.4 to 2.7) |
Overall Survival was the time from first administration of study treatment until the date of death.
| months | Belinostat |
|---|---|
| Overall Survival | 7.9 (6.1 to 13.9) |
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.
| Participants | Belinostat |
|---|---|
| Number of Participants With At Least One Serious Treatment-Emergent Adverse Event (TEAE) | 61 |
Results for this outcome have not been posted.
Collected over Up to 25 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Belinostat | 22/129 (17.1%) | 61/129 (47.3%) | 125/129 (96.9%) |
| Event | Belinostat |
|---|---|
| PneumoniaInfections and infestations | 10/129 |
| PyrexiaGeneral disorders | 6/129 |
| InfectionInfections and infestations | 4/129 |
| AnaemiaBlood and lymphatic system disorders | 3/129 |
| Blood creatinine increasedInvestigations | 3/129 |
| Multi-organ disorderGeneral disorders | 3/129 |
| ThrombocytopeniaBlood and lymphatic system disorders | 3/129 |
| BronchitisInfections and infestations | 3/129 |
| Deep vein thrombosisVascular disorders | 3/129 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 3/129 |
| Event | Belinostat |
|---|---|
| NauseaGastrointestinal disorders | 55/129 |
| FatigueGeneral disorders | 47/129 |
| PyrexiaGeneral disorders | 45/129 |
| AnemiaBlood and lymphatic system disorders | 41/129 |
| VomitingGastrointestinal disorders | 37/129 |
| ConstipationGastrointestinal disorders | 29/129 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 29/129 |
| DiarrheaGastrointestinal disorders | 28/129 |
| Edema PeripheralGeneral disorders | 27/129 |
| RashSkin and subcutaneous tissue disorders | 26/129 |
Full Analysis Set included all participants who were received at least 1 dose of belinostat.
| Age, Continuous(years) | Belinostat |
|---|---|
| Median | 63 (29 to 81) |
| Sex: Female, Male(Participants) | Belinostat |
|---|---|
| Female | 60 |
| Male | 69 |
Showing the first 100 of 117 sites across 17 countries.
Plan to share: No
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Spectrum Pharmaceuticals, Inc