TriangleNCT02332980 · OUTCOME
Confirmed All Response Rate of Patients Treated With Combination Therapy
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
- 1 year
What was measured
Confirmed response rate will be estimated by the number of patients with an objective status of complete response, incomplete blood count recovery, nodular partial response, clinical complete response or partial response while on the combination therapy divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true overall response rate to the combination will be calculated. In addition, the responders on this study will be further examined in an exploratory manner to determine if there are any patterns in prognostic factors or disease characteristics, including whether the patient had a Richter's transformation or ibrutinib-resistant disease, for both single agent pembrolizumab and combination therapy responders.
Groups in this outcome
Arm A (Continuation Phase)
CONTINUATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1. Patients also receive idelalisib PO BID on days 1-21 OR ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for up to 12 or 24 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
Arm C (Continuation Phase)
CONTINUATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1. Patients also receive idelalisib PO BID on days 1-21 OR ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for up to 12 or 24 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
| Group | Source count |
|---|---|
| Arm A (Continuation Phase) | 5 |
| Arm C (Continuation Phase) | 13 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Continuation Phase) | 0.6000 | Not reported | 0.1466 | 0.9473 | Not reported |
| Arm C (Continuation Phase) | 0.1538 | Not reported | 0.0192 | 0.4545 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.1466
- upper Limit
- 0.9473
- value
- 0.6000
- group Id
- OG001
- lower Limit
- 0.0192
- upper Limit
- 0.4545
- value
- 0.1538
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 13
- units
- Participants
- description
- Confirmed response rate will be estimated by the number of patients with an objective status of complete response, incomplete blood count recovery, nodular partial response, clinical complete response or partial response while on the combination therapy divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true overall response rate to the combination will be calculated. In addition, the responders on this study will be further examined in an exploratory manner to determine if there are any patterns in prognostic factors or disease characteristics, including whether the patient had a Richter's transformation or ibrutinib-resistant disease, for both single agent pembrolizumab and combination therapy responders.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- CONTINUATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1. Patients also receive idelalisib PO BID on days 1-21 OR ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for up to 12 or 24 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
- id
- OG000
- title
- Arm A (Continuation Phase)
- description
- CONTINUATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1. Patients also receive idelalisib PO BID on days 1-21 OR ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for up to 12 or 24 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
- id
- OG001
- title
- Arm C (Continuation Phase)
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- 1 year
- title
- Confirmed All Response Rate of Patients Treated With Combination Therapy
- type
- SECONDARY
- unit Of Measure
- proportion of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice