TriangleNCT04487106 · OUTCOME
Minimal Residual Disease Negativity
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
- Up to time of relapse, assessed up to 2.5 years
What was measured
Will be assessed by flow cytometry and estimated along with 95% credible intervals.
Analysis population: Of the five participants in Cohort A, three were evaluable for response. Of the 16 participants in Cohort B, 13 were evaluable for response.
Groups in this outcome
Cohort A (Newly Diagnosed AML Patients)
INDUCTION (CYCLE 1): Patients receive azacitidine IV over 30-60 minutes or SC on days 1-7, venetoclax PO QD on days 1-28, and trametinib PO QD on days 1-28 in the absence of disease progression or unacceptable toxicity. CONSOLIDATION (CYCLES 2-24): Patients receive azacitidine IV over 30-60 minutes or SC on days 1-7, venetoclax PO QD on days 1-21, and trametinib PO QD on days 1-28. Treatment repeats every 28 days for up to 23 cycles in the absence of disease progression or unacceptable toxicity. Azacitidine: Given IV or SC Trametinib: Given PO Venetoclax: Given PO
Cohort B (Relapsed/Refractory AML or Higher-risk MDS or CMML Patients)
INDUCTION (CYCLE 1): Patients receive azacitidine IV over 30-60 minutes or SC on days 1-7, venetoclax PO QD on days 1-28, and trametinib PO QD on days 1-28 in the absence of disease progression or unacceptable toxicity. CONSOLIDATION (CYCLES 2-24): Patients receive azacitidine IV over 30-60 minutes or SC on days 1-7, venetoclax PO QD on days 1-21, and trametinib PO QD on days 1-28. Treatment repeats every 28 days for up to 23 cycles in the absence of disease progression or unacceptable toxicity. Azacitidine: Given IV or SC Trametinib: Given PO Venetoclax: Given PO
| Group | Source count |
|---|---|
| Cohort A (Newly Diagnosed AML Patients) | 3 |
| Cohort B (Relapsed/Refractory AML or Higher-risk MDS or CMML Patients) | 13 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A (Newly Diagnosed AML Patients) | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort B (Relapsed/Refractory AML or Higher-risk MDS or CMML Patients) | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 13
- units
- Participants
- description
- Will be assessed by flow cytometry and estimated along with 95% credible intervals.
- groups
- description
- INDUCTION (CYCLE 1): Patients receive azacitidine IV over 30-60 minutes or SC on days 1-7, venetoclax PO QD on days 1-28, and trametinib PO QD on days 1-28 in the absence of disease progression or unacceptable toxicity. CONSOLIDATION (CYCLES 2-24): Patients receive azacitidine IV over 30-60 minutes or SC on days 1-7, venetoclax PO QD on days 1-21, and trametinib PO QD on days 1-28. Treatment repeats every 28 days for up to 23 cycles in the absence of disease progression or unacceptable toxicity. Azacitidine: Given IV or SC Trametinib: Given PO Venetoclax: Given PO
- id
- OG000
- title
- Cohort A (Newly Diagnosed AML Patients)
- description
- INDUCTION (CYCLE 1): Patients receive azacitidine IV over 30-60 minutes or SC on days 1-7, venetoclax PO QD on days 1-28, and trametinib PO QD on days 1-28 in the absence of disease progression or unacceptable toxicity. CONSOLIDATION (CYCLES 2-24): Patients receive azacitidine IV over 30-60 minutes or SC on days 1-7, venetoclax PO QD on days 1-21, and trametinib PO QD on days 1-28. Treatment repeats every 28 days for up to 23 cycles in the absence of disease progression or unacceptable toxicity. Azacitidine: Given IV or SC Trametinib: Given PO Venetoclax: Given PO
- id
- OG001
- title
- Cohort B (Relapsed/Refractory AML or Higher-risk MDS or CMML Patients)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Of the five participants in Cohort A, three were evaluable for response. Of the 16 participants in Cohort B, 13 were evaluable for response.
- reporting Status
- POSTED
- time Frame
- Up to time of relapse, assessed up to 2.5 years
- title
- Minimal Residual Disease Negativity
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice