TriangleNCT03306264 · OUTCOME
AML: Percentage of Participants With CR, CR With Incomplete Blood Count Recovery (CRi), CR With Incomplete Platelet Recovery (CRp), and CR Plus CRp Based on IWG 2003 AML Response Criteria
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to approximately 2.4 years
What was measured
CR was defined as absolute neutrophil content (ANC) ≥1000/ microliter (μL), platelets ≥100,000/μL, independence from red blood cell (RBC) and platelet transfusions over the past week, no leukemic blasts and \<5% leukemic blasts. CRp was defined as CR criteria except platelets \<100,000/μL.and platelet transfusion over the past week. CRi was defined as CR criteria except ANC \<1000/μL or platelets \<100,000/μL. Percentage of participants with CR, CRi, CRp, and CR Plus CRp based on IWG 2003 AML response criteria are reported.
Analysis population: Efficacy Analysis Set included all participants who received any amount of study treatment.
Groups in this outcome
AML: Sequence A: First ASTX727, Then IV Decitabine, Then ASTX727
Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycle 1 (each cycle = 28 days), followed by IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycle 2. A washout period of 23 days was maintained between the 2 cycles. From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.
AML: Sequence B: First IV Decitabine, Then ASTX727, Then ASTX727
Participants with AML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycle 1 (each cycle = 28 days) followed by ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycle 2. A washout period of 23 days was maintained between the 2 cycles. From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.
| Group | Source count |
|---|---|
| AML: Sequence A: First ASTX727, Then IV Decitabine, Then ASTX727 | 43 |
| AML: Sequence B: First IV Decitabine, Then ASTX727, Then ASTX727 | 44 |
Reported measurements
Complete Response (CR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| AML: Sequence A: First ASTX727, Then IV Decitabine, Then ASTX727 | 14.0 | Not reported | 5.3 | 27.9 | Not reported |
| AML: Sequence B: First IV Decitabine, Then ASTX727, Then ASTX727 | 29.5 | Not reported | 16.8 | 45.2 | Not reported |
CR with Incomplete Platelet Recovery (CRp)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| AML: Sequence A: First ASTX727, Then IV Decitabine, Then ASTX727 | 4.7 | Not reported | 0.6 | 15.8 | Not reported |
| AML: Sequence B: First IV Decitabine, Then ASTX727, Then ASTX727 | 0 | Not reported | 0.0 | 8.0 | Not reported |
CR with Incomplete Blood Count Recovery (CRi)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| AML: Sequence A: First ASTX727, Then IV Decitabine, Then ASTX727 | 11.6 | Not reported | 3.9 | 25.1 | Not reported |
| AML: Sequence B: First IV Decitabine, Then ASTX727, Then ASTX727 | 0 | Not reported | 0.0 | 8.0 | Not reported |
CR Plus CRp
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| AML: Sequence A: First ASTX727, Then IV Decitabine, Then ASTX727 | 18.6 | Not reported | 8.4 | 33.4 | Not reported |
| AML: Sequence B: First IV Decitabine, Then ASTX727, Then ASTX727 | 29.5 | Not reported | 16.8 | 45.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.3
- upper Limit
- 27.9
- value
- 14.0
- group Id
- OG001
- lower Limit
- 16.8
- upper Limit
- 45.2
- value
- 29.5
- title
- Complete Response (CR)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.6
- upper Limit
- 15.8
- value
- 4.7
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 8.0
- value
- 0
- title
- CR with Incomplete Platelet Recovery (CRp)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.9
- upper Limit
- 25.1
- value
- 11.6
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 8.0
- value
- 0
- title
- CR with Incomplete Blood Count Recovery (CRi)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 8.4
- upper Limit
- 33.4
- value
- 18.6
- group Id
- OG001
- lower Limit
- 16.8
- upper Limit
- 45.2
- value
- 29.5
- title
- CR Plus CRp
- denoms
- counts
- group Id
- OG000
- value
- 43
- group Id
- OG001
- value
- 44
- units
- Participants
- description
- CR was defined as absolute neutrophil content (ANC) ≥1000/ microliter (μL), platelets ≥100,000/μL, independence from red blood cell (RBC) and platelet transfusions over the past week, no leukemic blasts and \<5% leukemic blasts. CRp was defined as CR criteria except platelets \<100,000/μL.and platelet transfusion over the past week. CRi was defined as CR criteria except ANC \<1000/μL or platelets \<100,000/μL. Percentage of participants with CR, CRi, CRp, and CR Plus CRp based on IWG 2003 AML response criteria are reported.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycle 1 (each cycle = 28 days), followed by IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycle 2. A washout period of 23 days was maintained between the 2 cycles. From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.
- id
- OG000
- title
- AML: Sequence A: First ASTX727, Then IV Decitabine, Then ASTX727
- description
- Participants with AML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycle 1 (each cycle = 28 days) followed by ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycle 2. A washout period of 23 days was maintained between the 2 cycles. From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.
- id
- OG001
- title
- AML: Sequence B: First IV Decitabine, Then ASTX727, Then ASTX727
- param Type
- NUMBER
- population Description
- Efficacy Analysis Set included all participants who received any amount of study treatment.
- reporting Status
- POSTED
- time Frame
- Up to approximately 2.4 years
- title
- AML: Percentage of Participants With CR, CR With Incomplete Blood Count Recovery (CRi), CR With Incomplete Platelet Recovery (CRp), and CR Plus CRp Based on IWG 2003 AML Response Criteria
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice