TriangleNCT05184842 · OUTCOME
Best Overall Response in Patients With AML Based on ITT-PP Analysis
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- At the time of censoring of data, up to ~21 months
What was measured
Best Overall Response was also determined in patients with AML who were analyzed by ITT-PP analysis. The number/percentage of patients with Complete Remission (CR), Complete Remission with incomplete hematologic recovery (CRi), Morphologic Leukemia-free State (MLFS), and No Response is summarized based on ELN criteria summarized in corresponding Outcome Measures.
Analysis population: 21 patients who comprised the Primary Outcome analysis were part of the AML cohort. Results for 2 of the 21 patients were not evaluable by ITT-PP analysis.
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) | 19 |
Reported measurements
CR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Decitabine/Venetoclax (Single Arm) | 10 | Not reported | Not reported | Not reported | Not reported |
CRi
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Decitabine/Venetoclax (Single Arm) | 1 | Not reported | Not reported | Not reported | Not reported |
MLFS
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Decitabine/Venetoclax (Single Arm) | 1 | Not reported | Not reported | Not reported | Not reported |
No Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Decitabine/Venetoclax (Single Arm) | 7 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 10
- title
- CR
- categories
- measurements
- group Id
- OG000
- value
- 1
- title
- CRi
- categories
- measurements
- group Id
- OG000
- value
- 1
- title
- MLFS
- categories
- measurements
- group Id
- OG000
- value
- 7
- title
- No Response
- denoms
- counts
- group Id
- OG000
- value
- 19
- units
- Participants
- description
- Best Overall Response was also determined in patients with AML who were analyzed by ITT-PP analysis. The number/percentage of patients with Complete Remission (CR), Complete Remission with incomplete hematologic recovery (CRi), Morphologic Leukemia-free State (MLFS), and No Response is summarized based on ELN criteria summarized in corresponding Outcome Measures.
- 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
- COUNT_OF_PARTICIPANTS
- population Description
- 21 patients who comprised the Primary Outcome analysis were part of the AML cohort. Results for 2 of the 21 patients were not evaluable by ITT-PP analysis.
- reporting Status
- POSTED
- time Frame
- At the time of censoring of data, up to ~21 months
- title
- Best Overall Response in Patients With AML Based on ITT-PP Analysis
- type
- POST_HOC
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice