TriangleNCT05184842 · OUTCOME
Duration of Response (DOR) in AML Patients
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- At the time of censoring of data, up to ~21 months
What was measured
Median DOR was determined for AML patients who comprised the Primary Outcome Measure analysis. DOR was evaluated from the time of response after 12 weeks of induction until disease progression.
Analysis population: 21 patients who comprised the Primary Outcome analysis were part of the AML cohort.
Groups in this outcome
Decitabine/Venetoclax (Single Arm)
Administration: Decitabine is reconstituted with 5 ml sterile water to facilitate subcutaneous administration. Decitabine is given by subcutaneous injection. Venetoclax is taken as a tablet prepared by patients pharmacy. Venetoclax is given at a dose of 400 mg po once per week concurrently with the Decitabine dose (+/- 1 day allowed ). Venetoclax: Venetoclax 400 mg po on days 1, 8, 15 and 22 of each cycle (28-day cycle) Decitabine: Decitabine 0.2 mg/kg SQ (subcutaneous) on days 2, 9, 16, 23 (for aggressive disease will add decitabine on days 3, 10, 17, 24)
| Group | Source count |
|---|---|
| Decitabine/Venetoclax (Single Arm) | 21 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Decitabine/Venetoclax (Single Arm) | 5.5 | Not reported | 3.9 | NA | An upper limit for the 95% Confidence Interval for DOR was unable to be reached due to some AML patients continuing to respond to treatment at the time of cutoff for data analysis (i.e., \~21 months). |
Complete source fields
- classes
- categories
- measurements
- comment
- An upper limit for the 95% Confidence Interval for DOR was unable to be reached due to some AML patients continuing to respond to treatment at the time of cutoff for data analysis (i.e., \~21 months).
- group Id
- OG000
- lower Limit
- 3.9
- upper Limit
- NA
- value
- 5.5
- denoms
- counts
- group Id
- OG000
- value
- 21
- units
- Participants
- description
- Median DOR was determined for AML patients who comprised the Primary Outcome Measure analysis. DOR was evaluated from the time of response after 12 weeks of induction until disease progression.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Administration: Decitabine is reconstituted with 5 ml sterile water to facilitate subcutaneous administration. Decitabine is given by subcutaneous injection. Venetoclax is taken as a tablet prepared by patients pharmacy. Venetoclax is given at a dose of 400 mg po once per week concurrently with the Decitabine dose (+/- 1 day allowed ). Venetoclax: Venetoclax 400 mg po on days 1, 8, 15 and 22 of each cycle (28-day cycle) Decitabine: Decitabine 0.2 mg/kg SQ (subcutaneous) on days 2, 9, 16, 23 (for aggressive disease will add decitabine on days 3, 10, 17, 24)
- id
- OG000
- title
- Decitabine/Venetoclax (Single Arm)
- param Type
- MEDIAN
- population Description
- 21 patients who comprised the Primary Outcome analysis were part of the AML cohort.
- reporting Status
- POSTED
- time Frame
- At the time of censoring of data, up to ~21 months
- title
- Duration of Response (DOR) in AML Patients
- type
- POST_HOC
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice