Trial · NCT00865969
Belinostat in Relapsed or Refractory Peripheral T-Cell Lymphoma
NCT00865969, Phase 2, Completed, Spectrum Pharmaceuticals, Inc; results first posted 2021-09-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Belinostat in Relapsed or Refractory Peripheral T-Cell Lymphoma. Trials, record NCT00865969. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00865969
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Belinostat in Relapsed or Refractory Peripheral T-Cell Lymphoma
- NCT number
- NCT00865969
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 129 participants, actual
- Lead sponsor
- Spectrum Pharmaceuticals, Inc
- Conditions
- Peripheral T-cell Lymphoma
- Interventions
- Belinostat
- First posted
- 2009-03-20
- Last updated
- 2021-10-29
- Other registries' IDs
- eudract:2008-005843-40
- Results first posted
- 2021-09-16
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate | 24 months | 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. |
| Secondary | Time to Response | 24 months | 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. |
| Secondary | Duration of Response | 24 months | 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. |
| Secondary | Time to Progression | 24 months | 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. |
| Secondary | Progression Free Survival | 24 months | 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. |
| Secondary | Overall Survival | 24 months | Overall Survival was the time from first administration of study treatment until the date of death. |
| Secondary | Number of Participants With At Least One Serious Treatment-Emergent Adverse Event (TEAE) | 24 months | 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. |
| Other | Population Pharmacokinetics | 24 months |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate | 24 months | Efficacy Analysis Dataset included participants who received at least 1 dose of belinostat and had a confirmed peripheral T-cell lymphoma (PTCL) diagnosis. | percentage of participants | NUMBER |
| SECONDARY | Time to Response | 24 months | Efficacy Analysis Dataset included participants who received at least 1 dose of belinostat and had a confirmed PTCL diagnosis. Overall number of participants analyzed included responding participants (CR/PR) only. | weeks | MEDIAN |
| SECONDARY | Duration of Response | 24 months | Efficacy Analysis Dataset included participants who received at least 1 dose of belinostat and had a confirmed PTCL diagnosis. Overall number of participants analysed included responding participants (CR/PR) only. | months | MEDIAN |
| SECONDARY | Time to Progression | 24 months | Efficacy Analysis Dataset included participants who received at least 1 dose of belinostat and had a confirmed PTCL diagnosis. | months | MEDIAN |
| SECONDARY | Progression Free Survival | 24 months | Efficacy Analysis Dataset included participants who received at least 1 dose of belinostat and had a confirmed PTCL diagnosis. | months | MEDIAN |
| SECONDARY | Overall Survival | 24 months | Efficacy Analysis Dataset included participants who received at least 1 dose of belinostat and had a confirmed PTCL diagnosis. | months | MEDIAN |
| SECONDARY | Number of Participants With At Least One Serious Treatment-Emergent Adverse Event (TEAE) | 24 months | Full Analysis Dataset included all participants who received at least 1 dose of belinostat. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Population Pharmacokinetics | 24 months |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate | Belinostat | 25.8 | 95% Confidence Interval 18.3 to 34.6 | percentage of participants | |
| Time to Response | Belinostat | 5.6 | Full Range 4.3 to 50.4 | weeks | |
| Duration of Response | Belinostat | 13.6 | 95% Confidence Interval 4.5 to 29.4 | months | |
| Time to Progression | Belinostat | 2 | 95% Confidence Interval 1.5 to 2.9 | months | |
| Progression Free Survival | Belinostat | 1.6 | 95% Confidence Interval 1.4 to 2.7 | months | |
| Overall Survival | Belinostat | 7.9 | 95% Confidence Interval 6.1 to 13.9 | months | |
| Number of Participants With At Least One Serious Treatment-Emergent Adverse Event (TEAE) | Belinostat | 61 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Belinostat | 129 | |
| Overall Study | COMPLETED | Belinostat | 129 | |
| Overall Study | NOT COMPLETED | Belinostat | 0 |
Source ClinicalTrials.gov
Adverse events133
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Belinostat | 55 | 129 | |
| other | Fatigue | General disorders | Belinostat | 47 | 129 | |
| other | Pyrexia | General disorders | Belinostat | 45 | 129 | |
| other | Anemia | Blood and lymphatic system disorders | Belinostat | 41 | 129 | |
| other | Vomiting | Gastrointestinal disorders | Belinostat | 37 | 129 | |
| other | Constipation | Gastrointestinal disorders | Belinostat | 29 | 129 | |
| other | Diarrhea | Gastrointestinal disorders | Belinostat | 28 | 129 | |
| other | Dyspnea | Respiratory, thoracic and mediastinal disorders | Belinostat | 29 | 129 | |
| other | Edema Peripheral | General disorders | Belinostat | 27 | 129 | |
| other | Rash | Skin and subcutaneous tissue disorders | Belinostat | 26 | 129 |
1 to 10 of 133Source ClinicalTrials.gov
See all 133 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Belinostat | 22 | 129 |
| Total, other adverse events | Belinostat | 125 | 129 |
| Total, serious adverse events | Belinostat | 61 | 129 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26921086 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00865969
GET https://conductscience.org/api/trials/v1/NCT00865969/events?page=2