TriangleNCT01771107 · OUTCOME
Prognostic Value of FDG-PET in Patient With HIV and HL With Respect to 2 Year Progression Free Survival
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- proportion of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Baseline up to 2 years
What was measured
Log-rank analysis will be used to investigate the prognostic value of FDG-PET scans at baseline, after 2 courses and post-therapy in patients with HIV and HL with respect to progression free survival.
Analysis population: PET-CT positive status was used within each arm.
Groups in this outcome
Phase I - Brentuximab 1.2 mg/kg
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Brentuximab Vedotin: Given IV Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Pharmacological Study: Correlative studies Vinblastine: Given IV
Phase II - Brentuximab 1.2 m/kg
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Brentuximab Vedotin: Given IV
| Group | Source count |
|---|---|
| Phase I - Brentuximab 1.2 mg/kg | 5 |
| Phase II - Brentuximab 1.2 m/kg | 28 |
Reported measurements
PET-CT positive
| Group | Source count |
|---|---|
| Phase I - Brentuximab 1.2 mg/kg | 0 |
| Phase II - Brentuximab 1.2 m/kg | 2 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase II - Brentuximab 1.2 m/kg | 1.0 | Not reported | 1.0 | 1.0 | Not reported |
PET-CT negative
| Group | Source count |
|---|---|
| Phase I - Brentuximab 1.2 mg/kg | 5 |
| Phase II - Brentuximab 1.2 m/kg | 26 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I - Brentuximab 1.2 mg/kg | 1.0 | Not reported | 1.0 | 1.0 | Not reported |
| Phase II - Brentuximab 1.2 m/kg | 0.92 | Not reported | 0.716 | 0.979 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG001
- lower Limit
- 1.0
- upper Limit
- 1.0
- value
- 1.0
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- units
- Participants
- title
- PET-CT positive
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.0
- upper Limit
- 1.0
- value
- 1.0
- group Id
- OG001
- lower Limit
- 0.716
- upper Limit
- 0.979
- value
- 0.92
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 26
- units
- Participants
- title
- PET-CT negative
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 28
- units
- Participants
- description
- Log-rank analysis will be used to investigate the prognostic value of FDG-PET scans at baseline, after 2 courses and post-therapy in patients with HIV and HL with respect to progression free survival.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Brentuximab Vedotin: Given IV Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Pharmacological Study: Correlative studies Vinblastine: Given IV
- id
- OG000
- title
- Phase I - Brentuximab 1.2 mg/kg
- description
- Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Brentuximab Vedotin: Given IV
- id
- OG001
- title
- Phase II - Brentuximab 1.2 m/kg
- param Type
- NUMBER
- population Description
- PET-CT positive status was used within each arm.
- reporting Status
- POSTED
- time Frame
- Baseline up to 2 years
- title
- Prognostic Value of FDG-PET in Patient With HIV and HL With Respect to 2 Year Progression Free Survival
- type
- SECONDARY
- unit Of Measure
- proportion of participants
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Preserved source evidence · Not medical advice