TriangleNCT03306264 · OUTCOME
MDS/CMML: Percentage of Participants With Complete Response (CR), Marrow CR (mCR), Partial Response (PR), Hematologic Improvement (HI) Based on International Working Group (IWG) 2006 Myelodysplastic Syndromes (MDS) 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 2.7 years
What was measured
CR: normal peripheral, persistent granulocyte count ≥1.0x10\^9/liter(L), platelet ≥100x10\^9/L, Hemoglobin (Hgb) ≥11g/dL, normal bone marrow with persistent marrow blasts ≤5%. mCR: reduction of bone marrow blasts to≤5%, decrease by 50% or more with/without normalization of peripheral counts.PR: normal peripheral counts, granulocyte count ≥1.0x10\^9/L, platelet count ≥100x10\^9/L, Hgb ≥11 g/dL, normal bone marrow, marrow blasts \>5%, reduced by 50% or more for at least 4 weeks. HI: HI-E: Hb increase ≥1.5 g/dL in absence of RBC transfusions. HI-P: Absolute increase of platelet count from \<20 to \>20X10\^9/L by at least 100%,if more than 20x10\^9/L, by absolute increase of at least 30x10\^9/L in absence of platelet transfusions. HI-N: granulocyte increase ≥100%, by an absolute increase ≥0.5x10\^9/L for at least 8 weeks. Percentage of participants with CR, mCR, PR, and HI based on IWG 2003 MDS response criteria are reported. Response has been reported based on participants with MDS or CMML.
Analysis population: Efficacy Analysis Set included all participants who received any amount of study treatment.
Groups in this outcome
MDS: Sequence A: First ASTX727, Then IV Decitabine, Then ASTX727
Participants with MDS 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, treatment discontinuation for other reasons, or withdrawal from the study.
MDS: Sequence B: First IV Decitabine, Then ASTX727, Then ASTX727
Participants with MDS 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, treatment discontinuation for other reasons, or withdrawal from the study.
CMML: Sequence A: First ASTX727, Then IV Decitabine, Then ASTX727
Participants with CMML 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, treatment discontinuation for other reasons, or withdrawal from the study.
CMML: Sequence B: First IV Decitabine, Then ASTX727, Then ASTX727
Participants with CMML 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, treatment discontinuation for other reasons, or withdrawal from the study.
| Group | Source count |
|---|---|
| MDS: Sequence A: First ASTX727, Then IV Decitabine, Then ASTX727 | 61 |
| MDS: Sequence B: First IV Decitabine, Then ASTX727, Then ASTX727 | 56 |
| CMML: Sequence A: First ASTX727, Then IV Decitabine, Then ASTX727 | 5 |
| CMML: Sequence B: First IV Decitabine, Then ASTX727, Then ASTX727 | 11 |
Reported measurements
Complete Response (CR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MDS: Sequence A: First ASTX727, Then IV Decitabine, Then ASTX727 | 26.2 | Not reported | 15.8 | 39.1 | Not reported |
| MDS: Sequence B: First IV Decitabine, Then ASTX727, Then ASTX727 | 19.6 | Not reported | 10.2 | 32.4 | Not reported |
| CMML: Sequence A: First ASTX727, Then IV Decitabine, Then ASTX727 | 0 | Not reported | 0 | 0 | Not reported |
| CMML: Sequence B: First IV Decitabine, Then ASTX727, Then ASTX727 | 18.2 | Not reported | 2.3 | 51.8 | Not reported |
Marrow Complete Response (mCR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MDS: Sequence A: First ASTX727, Then IV Decitabine, Then ASTX727 | 29.5 | Not reported | 18.5 | 42.6 | Not reported |
| MDS: Sequence B: First IV Decitabine, Then ASTX727, Then ASTX727 | 30.4 | Not reported | 18.8 | 44.1 | Not reported |
| CMML: Sequence A: First ASTX727, Then IV Decitabine, Then ASTX727 | 40.0 | Not reported | 5.3 | 85.3 | Not reported |
| CMML: Sequence B: First IV Decitabine, Then ASTX727, Then ASTX727 | 54.5 | Not reported | 23.4 | 83.3 | Not reported |
Partial Response (PR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MDS: Sequence A: First ASTX727, Then IV Decitabine, Then ASTX727 | 0 | Not reported | 0 | 0 | Not reported |
| MDS: Sequence B: First IV Decitabine, Then ASTX727, Then ASTX727 | 0 | Not reported | 0 | 0 | Not reported |
| CMML: Sequence A: First ASTX727, Then IV Decitabine, Then ASTX727 | 0 | Not reported | 0 | 0 | Not reported |
| CMML: Sequence B: First IV Decitabine, Then ASTX727, Then ASTX727 | 0 | Not reported | 0 | 0 | Not reported |
HI: Erythroid Response (HI-E)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MDS: Sequence A: First ASTX727, Then IV Decitabine, Then ASTX727 | 0 | Not reported | 0 | 0 | Not reported |
| MDS: Sequence B: First IV Decitabine, Then ASTX727, Then ASTX727 | 1.8 | Not reported | 0.0 | 9.6 | Not reported |
| CMML: Sequence A: First ASTX727, Then IV Decitabine, Then ASTX727 | 20.0 | Not reported | 0.5 | 71.6 | Not reported |
| CMML: Sequence B: First IV Decitabine, Then ASTX727, Then ASTX727 | 0 | Not reported | 0 | 0 | Not reported |
HI: Platelet Response (HI-P)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MDS: Sequence A: First ASTX727, Then IV Decitabine, Then ASTX727 | 3.3 | Not reported | 0.4 | 11.3 | Not reported |
| MDS: Sequence B: First IV Decitabine, Then ASTX727, Then ASTX727 | 8.9 | Not reported | 3.0 | 19.6 | Not reported |
| CMML: Sequence A: First ASTX727, Then IV Decitabine, Then ASTX727 | 0 | Not reported | 0 | 0 | Not reported |
| CMML: Sequence B: First IV Decitabine, Then ASTX727, Then ASTX727 | 0 | Not reported | 0 | 0 | Not reported |
HI: Neutrophil Response (HI-N)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MDS: Sequence A: First ASTX727, Then IV Decitabine, Then ASTX727 | 0 | Not reported | 0 | 0 | Not reported |
| MDS: Sequence B: First IV Decitabine, Then ASTX727, Then ASTX727 | 0 | Not reported | 0 | 0 | Not reported |
| CMML: Sequence A: First ASTX727, Then IV Decitabine, Then ASTX727 | 0 | Not reported | 0 | 0 | Not reported |
| CMML: Sequence B: First IV Decitabine, Then ASTX727, Then ASTX727 | 9.1 | Not reported | 0.2 | 41.3 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 15.8
- upper Limit
- 39.1
- value
- 26.2
- group Id
- OG001
- lower Limit
- 10.2
- upper Limit
- 32.4
- value
- 19.6
- group Id
- OG002
- lower Limit
- 0
- upper Limit
- 0
- value
- 0
- group Id
- OG003
- lower Limit
- 2.3
- upper Limit
- 51.8
- value
- 18.2
- title
- Complete Response (CR)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 18.5
- upper Limit
- 42.6
- value
- 29.5
- group Id
- OG001
- lower Limit
- 18.8
- upper Limit
- 44.1
- value
- 30.4
- group Id
- OG002
- lower Limit
- 5.3
- upper Limit
- 85.3
- value
- 40.0
- group Id
- OG003
- lower Limit
- 23.4
- upper Limit
- 83.3
- value
- 54.5
- title
- Marrow Complete Response (mCR)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 0
- value
- 0
- group Id
- OG001
- lower Limit
- 0
- upper Limit
- 0
- value
- 0
- group Id
- OG002
- lower Limit
- 0
- upper Limit
- 0
- value
- 0
- group Id
- OG003
- lower Limit
- 0
- upper Limit
- 0
- value
- 0
- title
- Partial Response (PR)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 0
- value
- 0
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 9.6
- value
- 1.8
- group Id
- OG002
- lower Limit
- 0.5
- upper Limit
- 71.6
- value
- 20.0
- group Id
- OG003
- lower Limit
- 0
- upper Limit
- 0
- value
- 0
- title
- HI: Erythroid Response (HI-E)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.4
- upper Limit
- 11.3
- value
- 3.3
- group Id
- OG001
- lower Limit
- 3.0
- upper Limit
- 19.6
- value
- 8.9
- group Id
- OG002
- lower Limit
- 0
- upper Limit
- 0
- value
- 0
- group Id
- OG003
- lower Limit
- 0
- upper Limit
- 0
- value
- 0
- title
- HI: Platelet Response (HI-P)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 0
- value
- 0
- group Id
- OG001
- lower Limit
- 0
- upper Limit
- 0
- value
- 0
- group Id
- OG002
- lower Limit
- 0
- upper Limit
- 0
- value
- 0
- group Id
- OG003
- lower Limit
- 0.2
- upper Limit
- 41.3
- value
- 9.1
- title
- HI: Neutrophil Response (HI-N)
- denoms
- counts
- group Id
- OG000
- value
- 61
- group Id
- OG001
- value
- 56
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 11
- units
- Participants
- description
- CR: normal peripheral, persistent granulocyte count ≥1.0x10\^9/liter(L), platelet ≥100x10\^9/L, Hemoglobin (Hgb) ≥11g/dL, normal bone marrow with persistent marrow blasts ≤5%. mCR: reduction of bone marrow blasts to≤5%, decrease by 50% or more with/without normalization of peripheral counts.PR: normal peripheral counts, granulocyte count ≥1.0x10\^9/L, platelet count ≥100x10\^9/L, Hgb ≥11 g/dL, normal bone marrow, marrow blasts \>5%, reduced by 50% or more for at least 4 weeks. HI: HI-E: Hb increase ≥1.5 g/dL in absence of RBC transfusions. HI-P: Absolute increase of platelet count from \<20 to \>20X10\^9/L by at least 100%,if more than 20x10\^9/L, by absolute increase of at least 30x10\^9/L in absence of platelet transfusions. HI-N: granulocyte increase ≥100%, by an absolute increase ≥0.5x10\^9/L for at least 8 weeks. Percentage of participants with CR, mCR, PR, and HI based on IWG 2003 MDS response criteria are reported. Response has been reported based on participants with MDS or CMML.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with MDS 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, treatment discontinuation for other reasons, or withdrawal from the study.
- id
- OG000
- title
- MDS: Sequence A: First ASTX727, Then IV Decitabine, Then ASTX727
- description
- Participants with MDS 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, treatment discontinuation for other reasons, or withdrawal from the study.
- id
- OG001
- title
- MDS: Sequence B: First IV Decitabine, Then ASTX727, Then ASTX727
- description
- Participants with CMML 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, treatment discontinuation for other reasons, or withdrawal from the study.
- id
- OG002
- title
- CMML: Sequence A: First ASTX727, Then IV Decitabine, Then ASTX727
- description
- Participants with CMML 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, treatment discontinuation for other reasons, or withdrawal from the study.
- id
- OG003
- title
- CMML: 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 2.7 years
- title
- MDS/CMML: Percentage of Participants With Complete Response (CR), Marrow CR (mCR), Partial Response (PR), Hematologic Improvement (HI) Based on International Working Group (IWG) 2006 Myelodysplastic Syndromes (MDS) Response Criteria
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice