TriangleNCT00007345 · OUTCOME
Number of Participants With a Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- up to 56.5 days
What was measured
A rigorous composite assessment was employed with uni-dimensional measurements of skin and visceral disease sites assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). 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.
Analysis population: Two participants were excluded. After further analysis it was determined that the participants did not have PTCL but a different form of lymphoma that was not known at the onset of enrollment.
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) | 45 |
| Cutaneous T-cell Lymphoma (CTCL) | 84 |
Reported measurements
Complete Response + Partial Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Peripheral T-cell Lymphoma (PTCL) | 17 | Not reported | Not reported | Not reported | Not reported |
| Cutaneous T-cell Lymphoma (CTCL) | 28 | Not reported | Not reported | Not reported | Not reported |
Complete Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Peripheral T-cell Lymphoma (PTCL) | 8 | Not reported | Not reported | Not reported | Not reported |
| Cutaneous T-cell Lymphoma (CTCL) | 5 | Not reported | Not reported | Not reported | Not reported |
Partial Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Peripheral T-cell Lymphoma (PTCL) | 9 | Not reported | Not reported | Not reported | Not reported |
| Cutaneous T-cell Lymphoma (CTCL) | 23 | Not reported | Not reported | Not reported | Not reported |
Stable Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Peripheral T-cell Lymphoma (PTCL) | 5 | Not reported | Not reported | Not reported | Not reported |
| Cutaneous T-cell Lymphoma (CTCL) | 32 | Not reported | Not reported | Not reported | Not reported |
Progressive disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Peripheral T-cell Lymphoma (PTCL) | 18 | Not reported | Not reported | Not reported | Not reported |
| Cutaneous T-cell Lymphoma (CTCL) | 18 | Not reported | Not reported | Not reported | Not reported |
Not Evaluable
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Peripheral T-cell Lymphoma (PTCL) | 5 | Not reported | Not reported | Not reported | Not reported |
| Cutaneous T-cell Lymphoma (CTCL) | 6 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 17
- group Id
- OG001
- value
- 28
- title
- Complete Response + Partial Response
- categories
- measurements
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 5
- title
- Complete Response
- categories
- measurements
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 23
- title
- Partial Response
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 32
- title
- Stable Disease
- categories
- measurements
- group Id
- OG000
- value
- 18
- group Id
- OG001
- value
- 18
- title
- Progressive disease
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 6
- title
- Not Evaluable
- denoms
- counts
- group Id
- OG000
- value
- 45
- group Id
- OG001
- value
- 84
- units
- Participants
- description
- A rigorous composite assessment was employed with uni-dimensional measurements of skin and visceral disease sites assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). 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
- 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
- NUMBER
- population Description
- Two participants were excluded. After further analysis it was determined that the participants did not have PTCL but a different form of lymphoma that was not known at the onset of enrollment.
- reporting Status
- POSTED
- time Frame
- up to 56.5 days
- title
- Number of Participants With a Response
- type
- PRIMARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice