TriangleNCT01915498 · OUTCOME
Combined Phase 1/2: Investigator Assessed Overall Response Rate in Participants With R/R AML
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
- Response assessments were performed every 28 days through Month 12 and every 56 days thereafter until the end of treatment; median duration of treatment exposure for Phase 1 and 2 R/R AML participants was 5.4 months (range 0.4 to 34.2 months).
What was measured
For participants with R/R AML ORR is defined as the percentage of participants achieving an overall response of CR, CRi, CRp, PR, or MLFS based on the 2003 revised IWG criteria for AML. CR: - ANC \> 1.0 x10⁹/L - Platelet count \> 100 x10⁹/L - Bone marrow (BM) blasts \< 5% - Absence of blasts with Auer rods - Independence of red cell transfusions CRi: - All CR criteria except for residual neutropenia (ANC \< 1.0 x 10⁹/L CRp: - All CR criteria except for residual thrombocytopenia (platelet counts \< 100 x 10⁹/L) PR: - Meets hematologic criteria of CR - Decrease of BM blasts to 5-25% and decrease of pretreatment BM blast ≥ 50%. MLFS: - Bone marrow blasts \< 5% - Absence of blasts with Auer rods - Absence of extramedullary disease - No hematologic recovery required
Analysis population: All participants in Phase 1 and 2 with R/R AML who received at least one dose of study treatment.
Groups in this outcome
Enasidenib 100 mg QD
Participants in Phase 1 or 2 with relapsed or refractory (R/R) AML who received enasidenib 100 mg QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
| Group | Source count |
|---|---|
| Enasidenib 100 mg QD | 214 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Enasidenib 100 mg QD | 38.8 | Not reported | 32.2 | 45.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 32.2
- upper Limit
- 45.7
- value
- 38.8
- denoms
- counts
- group Id
- OG000
- value
- 214
- units
- Participants
- description
- For participants with R/R AML ORR is defined as the percentage of participants achieving an overall response of CR, CRi, CRp, PR, or MLFS based on the 2003 revised IWG criteria for AML. CR: - ANC \> 1.0 x10⁹/L - Platelet count \> 100 x10⁹/L - Bone marrow (BM) blasts \< 5% - Absence of blasts with Auer rods - Independence of red cell transfusions CRi: - All CR criteria except for residual neutropenia (ANC \< 1.0 x 10⁹/L CRp: - All CR criteria except for residual thrombocytopenia (platelet counts \< 100 x 10⁹/L) PR: - Meets hematologic criteria of CR - Decrease of BM blasts to 5-25% and decrease of pretreatment BM blast ≥ 50%. MLFS: - Bone marrow blasts \< 5% - Absence of blasts with Auer rods - Absence of extramedullary disease - No hematologic recovery required
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants in Phase 1 or 2 with relapsed or refractory (R/R) AML who received enasidenib 100 mg QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
- id
- OG000
- title
- Enasidenib 100 mg QD
- param Type
- NUMBER
- population Description
- All participants in Phase 1 and 2 with R/R AML who received at least one dose of study treatment.
- reporting Status
- POSTED
- time Frame
- Response assessments were performed every 28 days through Month 12 and every 56 days thereafter until the end of treatment; median duration of treatment exposure for Phase 1 and 2 R/R AML participants was 5.4 months (range 0.4 to 34.2 months).
- title
- Combined Phase 1/2: Investigator Assessed Overall Response Rate in Participants With R/R AML
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice