TriangleNCT00007345 · OUTCOME
Duration of Response (DOR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- Full Range
- Time frame
- up to 127 months
What was measured
DOR is defined as the date response was noted until disease was no longer considered to be responding. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria and the International Working Group Criteria (IWG).Complete response (CR) required clearing of all known disease sites. Partial response (PR) required documented response in skin (≥ 30% per RECIST) or lymph nodes (≥ 50% per the International Working Group (IWG) criteria, with response in both compartments for a determination of PR, IWG guidelines. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Progressive disease (PD) is at least a 20% increase in the sum of the target lesions, or the appearance of one or more new lesions. Lymph node disease was assessed bi-dimensionally using the IWG criteria. Bone marrow involvement, as recommended by IWG criteria, and presence of circulating malignant T-cells ascertained by flow cytometry.
Groups in this outcome
Peripheral T-cell Lymphoma (PTCL)
Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m\^2 and at 17.5 mg/m\^2 on days 1, 8, and 15 of a 28 day cycle.
Cutaneous T-cell Lymphoma (CTCL)
Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m\^2 and at 17.5 mg/m\^2 on days 1, 8, and 15 of a 28 day cycle.
| Group | Source count |
|---|---|
| Peripheral T-cell Lymphoma (PTCL) | 47 |
| Cutaneous T-cell Lymphoma (CTCL) | 84 |
Reported measurements
Complete Response/Partial Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Peripheral T-cell Lymphoma (PTCL) | 9 | Not reported | 2 | 76 | Not reported |
| Cutaneous T-cell Lymphoma (CTCL) | 13.8 | Not reported | 1 | 127 | Not reported |
Complete Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Peripheral T-cell Lymphoma (PTCL) | 74 | Not reported | 3 | 76 | Not reported |
| Cutaneous T-cell Lymphoma (CTCL) | 19.3 | Not reported | 8 | 127 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2
- upper Limit
- 76
- value
- 9
- group Id
- OG001
- lower Limit
- 1
- upper Limit
- 127
- value
- 13.8
- title
- Complete Response/Partial Response
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3
- upper Limit
- 76
- value
- 74
- group Id
- OG001
- lower Limit
- 8
- upper Limit
- 127
- value
- 19.3
- title
- Complete Response
- denoms
- counts
- group Id
- OG000
- value
- 47
- group Id
- OG001
- value
- 84
- units
- Participants
- description
- DOR is defined as the date response was noted until disease was no longer considered to be responding. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria and the International Working Group Criteria (IWG).Complete response (CR) required clearing of all known disease sites. Partial response (PR) required documented response in skin (≥ 30% per RECIST) or lymph nodes (≥ 50% per the International Working Group (IWG) criteria, with response in both compartments for a determination of PR, IWG guidelines. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Progressive disease (PD) is at least a 20% increase in the sum of the target lesions, or the appearance of one or more new lesions. Lymph node disease was assessed bi-dimensionally using the IWG criteria. Bone marrow involvement, as recommended by IWG criteria, and presence of circulating malignant T-cells ascertained by flow cytometry.
- dispersion Type
- Full Range
- groups
- description
- Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m\^2 and at 17.5 mg/m\^2 on days 1, 8, and 15 of a 28 day cycle.
- id
- OG000
- title
- Peripheral T-cell Lymphoma (PTCL)
- description
- Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m\^2 and at 17.5 mg/m\^2 on days 1, 8, and 15 of a 28 day cycle.
- id
- OG001
- title
- Cutaneous T-cell Lymphoma (CTCL)
- param Type
- MEDIAN
- reporting Status
- POSTED
- time Frame
- up to 127 months
- title
- Duration of Response (DOR)
- type
- PRIMARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice