TriangleNCT01193842 · OUTCOME
Tumor Response (Phase I)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to 2 years post treatment
What was measured
The percentage of participants whose best tumor response is complete response (CR) or partial response (PR). Based on clinical, radiologic (CT), and pathologic criteria, CR requires 1) complete disappearance of all detectable disease and disease-related symptoms if present before therapy, 2) bone marrow aspirate and biopsy to confirm a CR if initially positive or if clinically indicated by new abnormalities in the peripheral blood counts or blood smear, 3) negative PET results, depending on typically, variably, or unknown pre-treatment FDG status, and 4) spleen and/or liver, if considered to be enlarged before therapy on physical examination or CT scan, not being palpable on physical examination and considered normal size by imaging studies, and nodules related to lymphoma disappeared. PR includes 1) ≥50% decrease in sum of product of diameters (SPD), 2) no increase in size of nodes, liver, or spleen, 3) splenic/hepatic nodules regressed by ≥ 50% SPD, 4) no new sites of disease
Analysis population: Eligible participants who completed at least 1 cycle of treatment.
Groups in this outcome
Phase I: VR-DA-EPOCH, Dose Level 1
Arm A (VR-DA-EPOCH) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1)
Phase I: VR-DA-EPOCH, Dose Level 2
Arm A (VR-DA-EPOCH) with Vorinostat at 400 mg once a day on days 1-5 of a cycle (Phase I Dose Level 2)
Phase I: Arm C (VR-CHOP) Dose Level 1
Arm C (VR-CHOP) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1 for low risk participants). This arm was discontinued due to low accrual.
| Group | Source count |
|---|---|
| Phase I: VR-DA-EPOCH, Dose Level 1 | 6 |
| Phase I: VR-DA-EPOCH, Dose Level 2 | 6 |
| Phase I: Arm C (VR-CHOP) Dose Level 1 | 1 |
Reported measurements
Complete response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I: VR-DA-EPOCH, Dose Level 1 | 83.3 | Not reported | 35.9 | 99.6 | Not reported |
| Phase I: VR-DA-EPOCH, Dose Level 2 | 83.3 | Not reported | 35.9 | 99.6 | Not reported |
| Phase I: Arm C (VR-CHOP) Dose Level 1 | 100 | Not reported | 2.5 | 100 | Not reported |
Partial Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I: VR-DA-EPOCH, Dose Level 1 | 16.7 | Not reported | 0.4 | 64.1 | Not reported |
| Phase I: VR-DA-EPOCH, Dose Level 2 | 16.7 | Not reported | 0.4 | 64.1 | Not reported |
| Phase I: Arm C (VR-CHOP) Dose Level 1 | 0 | Not reported | 0 | 97.5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 35.9
- upper Limit
- 99.6
- value
- 83.3
- group Id
- OG001
- lower Limit
- 35.9
- upper Limit
- 99.6
- value
- 83.3
- group Id
- OG002
- lower Limit
- 2.5
- upper Limit
- 100
- value
- 100
- title
- Complete response
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.4
- upper Limit
- 64.1
- value
- 16.7
- group Id
- OG001
- lower Limit
- 0.4
- upper Limit
- 64.1
- value
- 16.7
- group Id
- OG002
- lower Limit
- 0
- upper Limit
- 97.5
- value
- 0
- title
- Partial Response
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 1
- units
- Participants
- description
- The percentage of participants whose best tumor response is complete response (CR) or partial response (PR). Based on clinical, radiologic (CT), and pathologic criteria, CR requires 1) complete disappearance of all detectable disease and disease-related symptoms if present before therapy, 2) bone marrow aspirate and biopsy to confirm a CR if initially positive or if clinically indicated by new abnormalities in the peripheral blood counts or blood smear, 3) negative PET results, depending on typically, variably, or unknown pre-treatment FDG status, and 4) spleen and/or liver, if considered to be enlarged before therapy on physical examination or CT scan, not being palpable on physical examination and considered normal size by imaging studies, and nodules related to lymphoma disappeared. PR includes 1) ≥50% decrease in sum of product of diameters (SPD), 2) no increase in size of nodes, liver, or spleen, 3) splenic/hepatic nodules regressed by ≥ 50% SPD, 4) no new sites of disease
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Arm A (VR-DA-EPOCH) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1)
- id
- OG000
- title
- Phase I: VR-DA-EPOCH, Dose Level 1
- description
- Arm A (VR-DA-EPOCH) with Vorinostat at 400 mg once a day on days 1-5 of a cycle (Phase I Dose Level 2)
- id
- OG001
- title
- Phase I: VR-DA-EPOCH, Dose Level 2
- description
- Arm C (VR-CHOP) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1 for low risk participants). This arm was discontinued due to low accrual.
- id
- OG002
- title
- Phase I: Arm C (VR-CHOP) Dose Level 1
- param Type
- NUMBER
- population Description
- Eligible participants who completed at least 1 cycle of treatment.
- reporting Status
- POSTED
- time Frame
- Up to 2 years post treatment
- title
- Tumor Response (Phase I)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice