TriangleNCT03268954 · OUTCOME
Number of Participants With Overall Response in Participants Who Have TP53 Mutations, 17p Deletions, and/or Are Determined to be in an Adverse Cytogenetic Risk Group
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
- From randomization until CR, CRi and PR (up to approximately 42 months)
What was measured
Disease responses for HR MDS/CMML based on Modified IWG Response Criteria for MDS; for low-blast AML on Revised IWG Response Criteria for AML. Overall response=CR + PR for HR MDS/CMML and CR + CRi + PR for low-blast AML. CR for HR MDS/CMML: \<=5% myeloblasts with normal maturation of all bone marrow cell lines, \>=11 g/dL Hgb, \>=100\*10\^9/L pl, \>=1.0\*10\^9/L neutrophils,0% blasts in peripheral blood and PR: all CR criteria met except bone marrow blasts\>=50% decrease over pretreatment but still\>5%. For low-blast AML-CR: morphologic leukemia-free state, \>1.0\*10\^9 neutrophils,\>=100\*10\^9/L pl, transfusion independence, no residual evidence of extramedullary leukemia; CR with incomplete blood count recovery (CRi): fulfill CR criteria except residual neutropenia\<1.0\*10\^9/L or pl\<100\*10\^9/L; PR: all CR hematological values but\>=50% decrease in the percentage of blasts to 5% to 25% in bone marrow aspirate.
Analysis population: ITT Population included all participants who were randomized. Overall number analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analysis for the specified category.
Groups in this outcome
Azacitidine 75 mg/m^2
Participants were administered azacitidine 75 mg/m\^2 IV or SC injection on Days 1 to 5, Days 8 and 9, in 28-day treatment cycles until disease progression or unacceptable toxicity or up to a maximum of 63 cycles.
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2
Participants were administered azacitidine 75 mg/m\^2 IV or SC injection on Days 1 to 5, Days 8 and 9 and pevonedistat 20 mg/m\^2 IV infusion, on Days 1, 3, and 5 in 28-day treatment cycles until disease progression or unacceptable toxicity or up to a maximum of 63 cycles.
| Group | Source count |
|---|---|
| Azacitidine 75 mg/m^2 | 52 |
| Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 | 54 |
Reported measurements
OR: HR MDS/CMML Participants
| Group | Source count |
|---|---|
| Azacitidine 75 mg/m^2 | 52 |
| Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 | 54 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Azacitidine 75 mg/m^2 | 14 | Not reported | Not reported | Not reported | Not reported |
| Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 | 13 | Not reported | Not reported | Not reported | Not reported |
OR: Low-blast AML Participants
| Group | Source count |
|---|---|
| Azacitidine 75 mg/m^2 | 37 |
| Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 | 32 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Azacitidine 75 mg/m^2 | 13 | Not reported | Not reported | Not reported | Not reported |
| Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 | 12 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- -19.44
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 13.75
- group Description
- OR: HR MDS/CMML Participants
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- =0.683
- p Value Comment
- P-value for HR MDS/CMML was obtained from a stratified Cochran-Mantel-Haenszel chi-square test
- param Type
- Absolute Rate Difference
- param Value
- -2.85
- statistical Method
- Cochran-Mantel-Haenszel
- ci Lower Limit
- -20.39
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 25.12
- group Description
- ORR: Low-blast AML Participants
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- =0.840
- p Value Comment
- P-value for Low-blast AML was obtained from an unstratified Cochran-Mantel-Haenszel chi-square test.
- param Type
- Absolute Rate Difference
- param Value
- 2.36
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- ci Lower Limit
- -19.44
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 13.75
- group Description
- OR: HR MDS/CMML Participants
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- =0.683
- p Value Comment
- P-value for HR MDS/CMML was obtained from a stratified Cochran-Mantel-Haenszel chi-square test
- param Type
- Absolute Rate Difference
- param Value
- -2.85
- statistical Method
- Cochran-Mantel-Haenszel
- ci Lower Limit
- -20.39
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 25.12
- group Description
- ORR: Low-blast AML Participants
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- =0.840
- p Value Comment
- P-value for Low-blast AML was obtained from an unstratified Cochran-Mantel-Haenszel chi-square test.
- param Type
- Absolute Rate Difference
- param Value
- 2.36
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 13
- denoms
- counts
- group Id
- OG000
- value
- 52
- group Id
- OG001
- value
- 54
- units
- Participants
- title
- OR: HR MDS/CMML Participants
- categories
- measurements
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 12
- denoms
- counts
- group Id
- OG000
- value
- 37
- group Id
- OG001
- value
- 32
- units
- Participants
- title
- OR: Low-blast AML Participants
- denoms
- counts
- group Id
- OG000
- value
- 52
- group Id
- OG001
- value
- 54
- units
- Participants
- description
- Disease responses for HR MDS/CMML based on Modified IWG Response Criteria for MDS; for low-blast AML on Revised IWG Response Criteria for AML. Overall response=CR + PR for HR MDS/CMML and CR + CRi + PR for low-blast AML. CR for HR MDS/CMML: \<=5% myeloblasts with normal maturation of all bone marrow cell lines, \>=11 g/dL Hgb, \>=100\*10\^9/L pl, \>=1.0\*10\^9/L neutrophils,0% blasts in peripheral blood and PR: all CR criteria met except bone marrow blasts\>=50% decrease over pretreatment but still\>5%. For low-blast AML-CR: morphologic leukemia-free state, \>1.0\*10\^9 neutrophils,\>=100\*10\^9/L pl, transfusion independence, no residual evidence of extramedullary leukemia; CR with incomplete blood count recovery (CRi): fulfill CR criteria except residual neutropenia\<1.0\*10\^9/L or pl\<100\*10\^9/L; PR: all CR hematological values but\>=50% decrease in the percentage of blasts to 5% to 25% in bone marrow aspirate.
- groups
- description
- Participants were administered azacitidine 75 mg/m\^2 IV or SC injection on Days 1 to 5, Days 8 and 9, in 28-day treatment cycles until disease progression or unacceptable toxicity or up to a maximum of 63 cycles.
- id
- OG000
- title
- Azacitidine 75 mg/m^2
- description
- Participants were administered azacitidine 75 mg/m\^2 IV or SC injection on Days 1 to 5, Days 8 and 9 and pevonedistat 20 mg/m\^2 IV infusion, on Days 1, 3, and 5 in 28-day treatment cycles until disease progression or unacceptable toxicity or up to a maximum of 63 cycles.
- id
- OG001
- title
- Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- ITT Population included all participants who were randomized. Overall number analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analysis for the specified category.
- reporting Status
- POSTED
- time Frame
- From randomization until CR, CRi and PR (up to approximately 42 months)
- title
- Number of Participants With Overall Response in Participants Who Have TP53 Mutations, 17p Deletions, and/or Are Determined to be in an Adverse Cytogenetic Risk Group
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice