Trial · NCT00106431
A Single Agent Phase II Study of Romidepsin (Depsipeptide, FK228) in the Treatment of Cutaneous T-cell Lymphoma (CTCL)
NCT00106431, Phase 2, Completed, Celgene; results first posted 2010-04-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Single Agent Phase II Study of Romidepsin (Depsipeptide, FK228) in the Treatment of Cutaneous T-cell Lymphoma (CTCL). Trials, record NCT00106431. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00106431
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Single Agent Phase II Study of Romidepsin (Depsipeptide, FK228) in the Treatment of Cutaneous T-cell Lymphoma (CTCL)
- NCT number
- NCT00106431
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 102 participants, actual
- Lead sponsor
- Celgene
- Conditions
- Cutaneous T-cell Lymphoma
- Interventions
- romidepsin (depsipeptide, FK228)
- First posted
- 2005-03-25
- Last updated
- 2019-10-30
- Results first posted
- 2010-04-23
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Percent of Patients (Pts) With Objective Disease Response | 6 months | The percent of pts with confirmed Objective Disease Response (confirmed best responses of complete response \[CR\], clinical complete response \[CCR\], or partial response \[PR\]). Responses were evaluated according to a composite assessment (Objective Primary Disease Response Evaluation Criteria - OPDREC). |
| Secondary | Duration of Objective Disease Response | Up to 10 months; median duration of follow up was 5.1 months | Duration of Objective Response was defined as the number of months from the date of the first disease response (clinical complete response \[CCR\], or partial response \[PR\]) (later confirmed) until the date of progression and was determined using Kaplan-Meier product-limit estimates. In this analysis, pts who did not progress were censored as of their last evaluation with an OPDREC assessment. |
| Secondary | Time to Objective Disease Response | Up to 10 months | Time to Objective Response was defined as the time in months from first dose date to the first date of objective disease response (later confirmed) and time to CCR was defined as the time in months from first dose date to the first date of CCR (later confirmed). |
| Secondary | Time to Disease Progression | Up to 10 months; median duration of follow up was 6.1 months | Time To Progression was defined as the duration from the date of the first study drug dose to the date of progression (PD). In this analysis, pts who did not progress were censored at their last evaluation with an OPDREC assessment. |
| Secondary | Decrease in Pruritus Visual Analogue Scale (VAS) Score of ≥30 mm or a Score of 0 for at Least 2 Consecutive Cycles. | Up to 10 months | Pruritus was reported monthly by pts using a 0 (no itching) to 100 (unbearable itching) mm visual analog scale (VAS). Pts were considered to have significant pruritus if the baseline VAS score was ≥ 30 mm. Clinically meaningful reduction in pruritus was defined as a decrease in VAS score of ≥ 30 mm or a score of 0 for at least 2 consecutive cycles. |
| Secondary | Duration of Objective Disease Control (ODC) | Up to 10 months; median duration of follow up was 6.0 months | For pts with confirmed ODC (pts with CR, CCR, PR, SD90 \[stable disease for 90 days\]) based on OPDREC, duration of ODC was summarized with descriptive statistics, including number of censored observations, and 25th, 50th, 75th percentiles of distribution, based on Kaplan-Meier product limit estimates. For pts with confirmed progressive disease (PD), duration of ODC was calculated from first date of study drug to first date of diagnosis of confirmed PD. For pts without confirmed PD, duration of ODC was calculated from first date of study drug to date of the last visit with any OPDREC data. |
| Secondary | Percent of Pts With Objective Disease Control | Up to 10 months | The percent of pts with confirmed ODC (CR, CCR, PR and SD90) based on OPDREC was summarized. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Percent of Patients (Pts) With Objective Disease Response | 6 months | Efficacy analysis based on interim analysis of data for as treated population | Percent of participants | NUMBER |
| SECONDARY | Duration of Objective Disease Response | Up to 10 months; median duration of follow up was 5.1 months | Efficacy analysis based on interim analysis of data for as treated population | Months | MEDIAN |
| SECONDARY | Time to Objective Disease Response | Up to 10 months | Efficacy analysis based on interim analysis of data for as treated population | Months | MEDIAN |
| SECONDARY | Time to Disease Progression | Up to 10 months; median duration of follow up was 6.1 months | Efficacy analysis based on interim analysis of data for as treated population | Months | MEDIAN |
| SECONDARY | Decrease in Pruritus Visual Analogue Scale (VAS) Score of ≥30 mm or a Score of 0 for at Least 2 Consecutive Cycles. | Up to 10 months | Patients meeting definition of moderate to severe pruritus on VAS (i.e., had a VAS of \>=30 mm) | participants | NUMBER |
| SECONDARY | Duration of Objective Disease Control (ODC) | Up to 10 months; median duration of follow up was 6.0 months | Efficacy analysis based on interim analysis of data for as treated population | Months | MEDIAN |
| SECONDARY | Percent of Pts With Objective Disease Control | Up to 10 months | Efficacy analysis based on interim analysis of data for as treated population | Percent of participants | NUMBER |
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 |
|---|---|---|---|---|---|
| The Percent of Patients (Pts) With Objective Disease Response | Romidepsin | 34 | Percent of participants | ||
| Duration of Objective Disease Response | Romidepsin | 14.91 | Full Range 0.03 to 19.81 | Months | |
| Time to Objective Disease Response | Romidepsin | 1.87 | Full Range 0.89 to 4.76 | Months | |
| Time to Disease Progression | Romidepsin | 8.28 | Full Range 0 to 21.65 | Months | |
| Decrease in Pruritus Visual Analogue Scale (VAS) Score of ≥30 mm or a Score of 0 for at Least 2 Consecutive Cycles. | Romidepsin | 25 | participants | ||
| Duration of Objective Disease Control (ODC) | Romidepsin | 17.67 | Full Range 0.03 to 19.81 | Months | |
| Percent of Pts With Objective Disease Control | Romidepsin | 64 | Percent of 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 | Romidepsin | 102 | |
| Overall Study | COMPLETED | Romidepsin | 37 | |
| Overall Study | NOT COMPLETED | Romidepsin | 65 |
Source ClinicalTrials.gov
Adverse events76
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 | Romidepsin | 57 | 102 | |
| other | Vomiting NOS | Gastrointestinal disorders | Romidepsin | 35 | 102 | |
| other | Diarrhoea NOS | Gastrointestinal disorders | Romidepsin | 20 | 102 | |
| other | Constipation | Gastrointestinal disorders | Romidepsin | 12 | 102 | |
| other | Dry Mouth | Gastrointestinal disorders | Romidepsin | 7 | 102 | |
| other | Abdominal Pain NOS | Gastrointestinal disorders | Romidepsin | 6 | 102 | |
| other | Fatigue | General disorders | Romidepsin | 34 | 102 | |
| other | Pyrexia | General disorders | Romidepsin | 20 | 102 | |
| other | Asthenia | General disorders | Romidepsin | 14 | 102 | |
| other | Oedema Peripheral | General disorders | Romidepsin | 8 | 102 |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Romidepsin | ||
| Total, other adverse events | Romidepsin | 99 | 102 |
| Total, serious adverse events | Romidepsin | 23 | 102 |
Source ClinicalTrials.gov
Papers4
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 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/NCT00106431
GET https://conductscience.org/api/trials/v1/NCT00106431/events?page=2