TriangleNCT00106431 · STUDY IN CONTEXT
A Single Agent Phase II Study of Romidepsin (Depsipeptide, FK228) in the Treatment of Cutaneous T-cell Lymphoma (CTCL)
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
Read the full study record and all posted results →
Linked outcomes
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).
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.
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).
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.
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.
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.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-cutaneous-t-cell-lymphomas
- nct id
- NCT00106431
- trial label
- A Single Agent Phase II Study of Romidepsin (Depsipeptide, FK228) in the Treatment of Cutaneous T-cell Lymphoma (CTCL)
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- regulator-cited
- discovery note
- Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
- outcome Count
- 6
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-cutaneous-t-cell-lymphomas
- nct id
- NCT00106431
- outcome key
- om-0000
- source section id
- NCT00106431-om-0000
- source outcome index
- 0
- endpoint
- The Percent of Patients (Pts) With Objective Disease Response
- endpoint definition
- 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).
- time origin
- 6 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Efficacy analysis based on interim analysis of data for as treated population
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-cutaneous-t-cell-lymphomas
- nct id
- NCT00106431
- outcome key
- om-0001
- source section id
- NCT00106431-om-0001
- source outcome index
- 1
- endpoint
- Duration of Objective Disease Response
- endpoint definition
- 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.
- time origin
- Up to 10 months; median duration of follow up was 5.1 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Efficacy analysis based on interim analysis of data for as treated population
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-cutaneous-t-cell-lymphomas
- nct id
- NCT00106431
- outcome key
- om-0002
- source section id
- NCT00106431-om-0002
- source outcome index
- 2
- endpoint
- Time to Objective Disease Response
- endpoint definition
- 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).
- time origin
- Up to 10 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Efficacy analysis based on interim analysis of data for as treated population
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-cutaneous-t-cell-lymphomas
- nct id
- NCT00106431
- outcome key
- om-0003
- source section id
- NCT00106431-om-0003
- source outcome index
- 3
- endpoint
- Time to Disease Progression
- endpoint definition
- 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.
- time origin
- Up to 10 months; median duration of follow up was 6.1 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Efficacy analysis based on interim analysis of data for as treated population
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-cutaneous-t-cell-lymphomas
- nct id
- NCT00106431
- outcome key
- om-0004
- source section id
- NCT00106431-om-0004
- source outcome index
- 4
- endpoint
- Decrease in Pruritus Visual Analogue Scale (VAS) Score of ≥30 mm or a Score of 0 for at Least 2 Consecutive Cycles.
- endpoint definition
- 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.
- time origin
- Up to 10 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Patients meeting definition of moderate to severe pruritus on VAS (i.e., had a VAS of \>=30 mm)
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-cutaneous-t-cell-lymphomas
- nct id
- NCT00106431
- outcome key
- om-0005
- source section id
- NCT00106431-om-0005
- source outcome index
- 5
- endpoint
- Duration of Objective Disease Control (ODC)
- endpoint definition
- 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.
- time origin
- Up to 10 months; median duration of follow up was 6.0 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Efficacy analysis based on interim analysis of data for as treated population
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-cutaneous-t-cell-lymphomas
- nct id
- NCT00106431
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Romidepsin
- regimen
- Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
- analyzed count
- 96
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00106431-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-cutaneous-t-cell-lymphomas
- nct id
- NCT00106431
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Romidepsin
- regimen
- Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
- analyzed count
- 96
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00106431-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-cutaneous-t-cell-lymphomas
- nct id
- NCT00106431
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Romidepsin
- regimen
- Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
- analyzed count
- 96
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00106431-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-cutaneous-t-cell-lymphomas
- nct id
- NCT00106431
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Romidepsin
- regimen
- Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
- analyzed count
- 96
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00106431-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-cutaneous-t-cell-lymphomas
- nct id
- NCT00106431
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Romidepsin
- regimen
- Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
- analyzed count
- 52
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00106431-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-cutaneous-t-cell-lymphomas
- nct id
- NCT00106431
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Romidepsin
- regimen
- Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
- analyzed count
- 96
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00106431-om-0005#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-cutaneous-t-cell-lymphomas
- nct id
- NCT00106431
- harm key
- EG000
- source section id
- NCT00106431-ae
- event group key
- EG000
- event group label
- Romidepsin
- serious affected
- 23
- serious at risk
- 102
- other affected
- 99
- other at risk
- 102
- frequency threshold
- 5
- collection period
- Treatment emergent events were collected from first dose to last visit which occurred approximately 1 month after the last dose. Patients were to be treated for 6 cycles (approximately 6 months) or until progression.
- event definition
- Patients could remain on treatment after 6 months if they experienced a response to treatment.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice