Trial · NCT00274651
A Phase II Clinical Trial of PXD101 in Patients With Recurrent or Refractory Cutaneous and Peripheral T-Cell Lymphomas
NCT00274651, Phase 2, Terminated, Valerio Therapeutics; results first posted 2014-10-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase II Clinical Trial of PXD101 in Patients With Recurrent or Refractory Cutaneous and Peripheral T-Cell Lymphomas. Trials, record NCT00274651. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00274651
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase II Clinical Trial of PXD101 in Patients With Recurrent or Refractory Cutaneous and Peripheral T-Cell Lymphomas
- NCT number
- NCT00274651
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 53 participants, actual
- Lead sponsor
- Valerio Therapeutics
- Conditions
- Cutaneous T-Cell Lymphoma, Peripheral T-Cell Lymphoma, Non-Hodgkin's Lymphoma
- Interventions
- belinostat
- First posted
- 2006-01-11
- Last updated
- 2015-07-28
- Results first posted
- 2014-10-27
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate in Patients With Recurrent or Refractory Cutaneous T-cell Lymphoma (CTCL) | throughout the study, or for a maximum of 2 years | Tumor response was assessed using Cheson (Cheson 2007) and SWAT criteria. The SWAT score represents the product of the percentage total body surface area (TBSA) involvement of each lesion type (patch, plaque, and tumor or ulceration), multiplied by a weighting factor. |
| Primary | Objective Response Rate in Patients With Recurrent or Refractory Peripheral T-cell Lymphoma (PTCL)) | throughout the study, or for a maximum of 2 years | Tumor response was assessed using the revised criteria of Cheson (Cheson 2007).Tumor assessments were done using conventional radiographic methods, e.g. CT or CT/PET. |
| Secondary | Time to Progression | throughout the study, or for a maximum of 2 years | Time to progression was defined as the interval between the first date of treatment and the first notation of disease progression. |
| Secondary | Time to Response | throughout the study, or for a maximum of 2 years | Time to response was defined as the interval between the first date of treatment and the first notation of response. |
| Secondary | Duration of Response | throughout the study, or for a maximum of 2 years | Duration of response was defined as the time from first notation of response until the time of first notation of disease progression. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate in Patients With Recurrent or Refractory Cutaneous T-cell Lymphoma (CTCL) | throughout the study, or for a maximum of 2 years | At termination OR was noted in 1/13 patients (Simon Stage 1). With 29 patients in the CTCL arm the demand for expansion to Simon Stage 2 lacked 5 patients and the study was stopped. Instead OR was done as secondary efficacy analysis (ITT and PP (per protocol)) with OR calculated without accounting for Simon design and with 95% confidence intervals | ||
| PRIMARY | Objective Response Rate in Patients With Recurrent or Refractory Peripheral T-cell Lymphoma (PTCL)) | throughout the study, or for a maximum of 2 years | Primary efficacy analysis is based on the ITT analysis set, where the OR are calculated, and the proportion ± 80% CI (confidence interval) specified by Koyama \& Chen (2008) are presented | percentage of patients with OR | NUMBER |
| SECONDARY | Time to Progression | throughout the study, or for a maximum of 2 years | Time to Progression (ITT population) was estimated using the Kaplan-Meier method for CTCL and PTCL arms. As progression was not observed in six patients in Arm A and 10 patients in Arm B, a total of 37 patients progressed, and the the median time to progression and the full range (days) are presented. | Days | MEDIAN |
| SECONDARY | Time to Response | throughout the study, or for a maximum of 2 years | Time to response (ITT population) was estimated using the Kaplan-Meier method for CTCL and PTCL arms. For 4 patients with CTCL and 6 patients with PTCL, response was recorded. The median time to response and the full range (days) are presented. | Days | MEDIAN |
| SECONDARY | Duration of Response | throughout the study, or for a maximum of 2 years | Duration of response (ITT population) was estimated by Kaplan-Meier method for CTCL/PTCL arms. 2 CTCL and 2 PTCL patients did not progress and were censored. Median duration of response and full range (days) are presented for 2 patients with CTCL and 4 patients with PTCL. The 2 CTCL patients being evaluable had response durations of 56 and 129 days | Days | MEDIAN |
| POST_HOC | Objective Response Rate in Patients With Recurrent or Refractory Cutaneous T-cell Lymphoma (CTCL) | throughout the study, or for a maximum of 2 years | At termination OR was noted in 1/13 patients (Simon Stage 1). With 29 patients in the CTCL arm the demand for expansion to Simon Stage 2 lacked 5 patients and the study was stopped. Instead OR was done as secondary efficacy analysis (ITT and PP (per protocol)) with OR calculated without accounting for Simon design and with 95% confidence intervals | participants | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate in Patients With Recurrent or Refractory Peripheral T-cell Lymphoma (PTCL)) | PTCL (ITT Population) | 25 | percentage of patients with OR | ||
| Time to Progression | Arm A (CTCL, ITT Population) | 43 | Full Range 15 to 304 | Days | |
| Time to Progression | Arm B (PTCL, ITT Population) | 82 | Full Range 9 to 890 | Days | |
| Time to Response | Arm A (CTCL, ITT Population) | 40 | Full Range 15 to 176 | Days | |
| Time to Response | Arm B (PTCL, ITT Population) | 100 | Full Range 9 to 431 | Days | |
| Duration of Response | Arm A (CTCL, ITT Population) | 83 | Full Range 56 to 129 | Days | |
| Duration of Response | Arm B (PTCL, ITT Population) | 109 | Full Range 7 to 460 | Days | |
| Objective Response Rate in Patients With Recurrent or Refractory Cutaneous T-cell Lymphoma (CTCL) | Arm A (CTCL, ITT Population) | 4 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A (CTCL, ITT Population) | 29 | |
| Overall Study | STARTED | Arm B (PTCL, ITT Population) | 24 | |
| Overall Study | COMPLETED | Arm A (CTCL, ITT Population) | 1 | |
| Overall Study | COMPLETED | Arm B (PTCL, ITT Population) | 4 | |
| Overall Study | NOT COMPLETED | Arm A (CTCL, ITT Population) | 28 | |
| Overall Study | NOT COMPLETED | Arm B (PTCL, ITT Population) | 20 |
Source ClinicalTrials.gov
Adverse events184
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 | Fatigue | General disorders | Arm A (CTCL, ITT Population) | 6 | 29 | 11 |
| other | Fatigue | General disorders | Arm B (PTCL, ITT Population) | 8 | 24 | 11 |
| other | Pyrexia | General disorders | Arm A (CTCL, ITT Population) | 5 | 29 | 9 |
| other | Pyrexia | General disorders | Arm B (PTCL, ITT Population) | 6 | 24 | 16 |
| other | Infusion site pain | General disorders | Arm A (CTCL, ITT Population) | 6 | 29 | 6 |
| other | Infusion site pain | General disorders | Arm B (PTCL, ITT Population) | 3 | 24 | 3 |
| other | Oedema peripheral | General disorders | Arm A (CTCL, ITT Population) | 6 | 29 | 7 |
| other | Oedema peripheral | General disorders | Arm B (PTCL, ITT Population) | 1 | 24 | 1 |
| other | Injection site reaction | General disorders | Arm A (CTCL, ITT Population) | 0 | 29 | 0 |
| other | Injection site reaction | General disorders | Arm B (PTCL, ITT Population) | 5 | 24 | 9 |
1 to 10 of 184Source ClinicalTrials.gov
See all 184 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A (CTCL, ITT Population) | ||
| Total, all-cause mortality | Arm B (PTCL, ITT Population) | ||
| Total, other adverse events | Arm A (CTCL, ITT Population) | 29 | 29 |
| Total, other adverse events | Arm B (PTCL, ITT Population) | 23 | 24 |
| Total, serious adverse events | Arm A (CTCL, ITT Population) | 7 | 29 |
| Total, serious adverse events | Arm B (PTCL, ITT Population) | 8 | 24 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25404094 | DERIVED |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Arm A (CTCL, ITT Population) vs Arm B (PTCL, ITT Population): serious adverse events |
Source Trial comparisons
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/NCT00274651
GET https://conductscience.org/api/trials/v1/NCT00274651/events?page=2