TriangleNCT03306264 · OUTCOME
AML: Time to First Response, Best Response and Complete Response 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
- MEDIAN
- Unit
- months
- Interval / dispersion
- Full Range
- Time frame
- Up to approximately 2.4 years
What was measured
Time to first response was defined as time in months from the date of first treatment to the first date when any response is achieved. Time to best response was defined in months from the date of first treatment to the first date when a subject's best response, in the order of CR, CRi (or CRp or CRh), or PR, was achieved. Time to CR was defined in months from the date of first treatment to the first date when CR is achieved. CR:ANC ≥1000/ microliter (μL),platelets ≥100,000/μL,independence from RBC and platelet transfusions over the past week, no leukemic blasts, and \<5% leukemic blasts.CRp: CR criteria except ANC ≥1000/μL, platelets \< 100,000/μL.and platelet transfusion over the past week. CRi:CR criteria except ANC \<1000/μL or platelets \<100,000/μL.CRh: \<5% of blasts in the bone marrow,platelets \>50,000/μL and ANC \>500/μL, independence from RBC and platelet transfusions within 7 days and peripheral blast ≤1%. PR: CR criteria except decrease of ≥50% in leukemic blasts.
Analysis population: Efficacy Analysis Set included all participants who received any amount of study treatment.
Groups in this outcome
AML: ASTX727 or IV Decitabine
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 or the converse. 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to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.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: ASTX727 or IV Decitabine | 87 |
Reported measurements
Time to First Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| AML: ASTX727 or IV Decitabine | 2.91 | Not reported | 1.9 | 6.5 | Not reported |
Time to Best Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| AML: ASTX727 or IV Decitabine | 3.45 | Not reported | 1.9 | 7.5 | Not reported |
Time to Complete Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| AML: ASTX727 or IV Decitabine | 3.02 | Not reported | 1.9 | 7.5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.9
- upper Limit
- 6.5
- value
- 2.91
- title
- Time to First Response
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.9
- upper Limit
- 7.5
- value
- 3.45
- title
- Time to Best Response
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.9
- upper Limit
- 7.5
- value
- 3.02
- title
- Time to Complete Response
- denoms
- counts
- group Id
- OG000
- value
- 87
- units
- Participants
- description
- Time to first response was defined as time in months from the date of first treatment to the first date when any response is achieved. Time to best response was defined in months from the date of first treatment to the first date when a subject's best response, in the order of CR, CRi (or CRp or CRh), or PR, was achieved. Time to CR was defined in months from the date of first treatment to the first date when CR is achieved. CR:ANC ≥1000/ microliter (μL),platelets ≥100,000/μL,independence from RBC and platelet transfusions over the past week, no leukemic blasts, and \<5% leukemic blasts.CRp: CR criteria except ANC ≥1000/μL, platelets \< 100,000/μL.and platelet transfusion over the past week. CRi:CR criteria except ANC \<1000/μL or platelets \<100,000/μL.CRh: \<5% of blasts in the bone marrow,platelets \>50,000/μL and ANC \>500/μL, independence from RBC and platelet transfusions within 7 days and peripheral blast ≤1%. PR: CR criteria except decrease of ≥50% in leukemic blasts.
- dispersion Type
- Full Range
- 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 or the converse. 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: ASTX727 or IV Decitabine
- param Type
- MEDIAN
- 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: Time to First Response, Best Response and Complete Response Based on IWG 2003 AML Response Criteria
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice