Trial · NCT01187446
Low-dose (12 Gy) TSEBT+Vorinostat Versus Low-dose TSEBT Monotherapy in Mycosis Fungoides
NCT01187446, Phase 1, Phase 2, Terminated, Stanford University; results first posted 2017-11-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Low-dose (12 Gy) TSEBT+Vorinostat Versus Low-dose TSEBT Monotherapy in Mycosis Fungoides. Trials, record NCT01187446. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01187446
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Low-dose (12 Gy) TSEBT+Vorinostat Versus Low-dose TSEBT Monotherapy in Mycosis Fungoides
- NCT number
- NCT01187446
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 28 participants, actual
- Lead sponsor
- Stanford University
- Conditions
- Cutaneous Lymphoma, Cutaneous T-cell Lymphoma
- Interventions
- Total skin electron beam therapy (TSEBT), Vorinostat
- First posted
- 2010-08-24
- Last updated
- 2017-11-20
- Results first posted
- 2017-11-20
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Clinical Response (CCR) | Week 8 | Complete Clinical Response (CCR) at week 8 as determined by an Modified Severity-Weighted Assessment Tool (mSWAT) score of 0. mSWAT is an objective, quantitative, severity-weighted method to assess the extent of mycosis fungoides (MF) lesions, and is determined by total body surface area (%TBSA) of the lesion by a severity-weighting factor (1 = patch; 2 = plaque; 4 = tumor). O% TBSA produces a product of 0, indicating complete response. |
| Secondary | Safety and Tolerability as Measured by Severity and Frequency of Adverse Events | Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first. | Adverse events occurring at least 10% out of evaluable participants, and it's corresponding rate in the opposing arm. |
| Secondary | Clinical Response Rate (CRR) | Week 8 | Clinical Response Rate (CRR) at week 8 as determined by an Modified Severity-Weighted Assessment Tool (mSWAT) score of 0, consisting of complete response (CR) rate; partial response (PR) rate; stable disease (SD) rate; or progressive disease (PD) rate. CR = 100% clearance of skin disease (mSWAT score = 0) PR = 50%to \<100% clearance of skin disease as measured by \> 50% decrease of mSWAT score compared with baseline SD = Not CR, PR, or PD PD = Whichever is met first of: 1. \> 25% increase in skin disease from baseline as measured by \> 25% increase of mSWAT score compared with baseline 2. New tumor (T3) lesions in patients without prior T3 lesions (T1, T2, T4) or 3. In responders (confirmed), increase in skin disease over nadir by 50% of baseline as measured by mSWAT score of \> \[nadir + \> 50% of baseline\] 4. Relapse applies to any new disease after confirmed CR |
| Secondary | Duration of Clinical Benefit (Per Protocol Follow-up) | 48 weeks after completion of treatment | Duration of clinical benefit represents the period of time that clinical response was maintained. Duration of clinical benefit is reported as the median period of time from the initiation of treatment until progressive disease, as measured by the mSWAT skin assessment, and censored at the final per-protocol assessment (48 weeks) |
| Secondary | Duration of Clinical Benefit (Supplemental Follow-up) | 140 weeks | Duration of clinical benefit represents the period of time that clinical response was maintained. Duration of clinical benefit is reported as the median period of time from the initiation of treatment or until progressive disease, as measured by the mSWAT skin assessment. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Complete Clinical Response (CCR) | Week 8 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Safety and Tolerability as Measured by Severity and Frequency of Adverse Events | Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first. | Number of patients | NUMBER | |
| SECONDARY | Clinical Response Rate (CRR) | Week 8 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Duration of Clinical Benefit (Per Protocol Follow-up) | 48 weeks after completion of treatment | The data are reported for the per-protocol period of follow-up (48 weeks). | Weeks | MEDIAN |
| SECONDARY | Duration of Clinical Benefit (Supplemental Follow-up) | 140 weeks | The data are reported for the full period for which participant data are available. | weeks | MEDIAN |
Source ClinicalTrials.gov
Results by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Complete Clinical Response (CCR) | TSEBT Only | 3 | Participants | ||
| Complete Clinical Response (CCR) | TSEBT Plus Vorinostat | 3 | Participants | ||
| Safety and Tolerability as Measured by Severity and Frequency of Adverse Events | TSEBT Only | Alopecia | 7 | Number of patients | |
| Safety and Tolerability as Measured by Severity and Frequency of Adverse Events | TSEBT Plus Vorinostat | Alopecia | 10 | Number of patients | |
| Safety and Tolerability as Measured by Severity and Frequency of Adverse Events | TSEBT Only | Fatigue | 4 | Number of patients | |
| Safety and Tolerability as Measured by Severity and Frequency of Adverse Events | TSEBT Plus Vorinostat | Fatigue | 10 | Number of patients | |
| Safety and Tolerability as Measured by Severity and Frequency of Adverse Events | TSEBT Only | Extremity Pain | 9 | Number of patients | |
| Safety and Tolerability as Measured by Severity and Frequency of Adverse Events | TSEBT Plus Vorinostat | Extremity Pain | 6 | Number of patients | |
| Safety and Tolerability as Measured by Severity and Frequency of Adverse Events | TSEBT Only | Nausea | 0 | Number of patients | |
| Safety and Tolerability as Measured by Severity and Frequency of Adverse Events | TSEBT Plus Vorinostat | Nausea | 8 | Number of patients |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | TSEBT Only | 14 | |
| Overall Study | STARTED | TSEBT Plus Vorinostat | 14 | |
| Overall Study | COMPLETED | TSEBT Only | 14 | |
| Overall Study | COMPLETED | TSEBT Plus Vorinostat | 13 | |
| Overall Study | NOT COMPLETED | TSEBT Only | 0 | |
| Overall Study | NOT COMPLETED | TSEBT Plus Vorinostat | 1 |
Source ClinicalTrials.gov
Adverse events86
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 | Abscess of Head and Neck | Skin and subcutaneous tissue disorders | TSEBT Only | 1 | 14 | |
| other | Abscess of Head and Neck | Skin and subcutaneous tissue disorders | TSEBT & Vorinostat | 0 | 14 | |
| other | Actinic Keratosis | Skin and subcutaneous tissue disorders | TSEBT Only | 1 | 14 | |
| other | Actinic Keratosis | Skin and subcutaneous tissue disorders | TSEBT & Vorinostat | 0 | 14 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | TSEBT Only | 7 | 14 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | TSEBT & Vorinostat | 10 | 14 | |
| other | Anemia | Blood and lymphatic system disorders | TSEBT Only | 0 | 14 | |
| other | Anemia | Blood and lymphatic system disorders | TSEBT & Vorinostat | 1 | 14 | |
| other | Anorexia | Psychiatric disorders | TSEBT Only | 0 | 14 | |
| other | Anorexia | Psychiatric disorders | TSEBT & Vorinostat | 2 | 14 |
1 to 10 of 86Source ClinicalTrials.gov
See all 86 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TSEBT Only | ||
| Total, all-cause mortality | TSEBT & Vorinostat | ||
| Total, other adverse events | TSEBT Only | 14 | 14 |
| Total, other adverse events | TSEBT & Vorinostat | 14 | 14 |
| Total, serious adverse events | TSEBT Only | 1 | 14 |
| Total, serious adverse events | TSEBT & Vorinostat | 0 | 14 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| TSEBT Only vs TSEBT Plus Vorinostat: Complete Clinical Response (CCR) | Trial comparisons |
| TSEBT Only vs TSEBT & Vorinostat: serious adverse events | 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/NCT01187446
GET https://conductscience.org/api/trials/v1/NCT01187446/results?page=2