TriangleNCT02397720 · OUTCOME
Participants With a Response
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
- Up to 7 years, 6 months
What was measured
Responders are patients who obtain a Complete Remission (CR), Complete Remission with Incomplete blood count recovery CRi, Complete Remission with Incomplete Platelet Recovery (CRp) or Partial Remission (PR), with or without cytogenetic response, hematologic improvements (HI), and morphologic leukemia-free state. CR is counts of 0 circulating blasts, Neutrophil count of \>/= 1.0 x 10\^9/L, Platelet count \>/= 100 x 10 \^9/L. Bone marrow \</= 5% blasts, No auer rods, No extramedullary disease. CRp is patients who have achieved a CR except for incomplete platelet recovery (\<100 x 10\^9/L). CRi is counts of 0 circulating blasts, Neutrophil count of \>/= 1.0 x 10\^9/L OR Platelet count \>/= 100 x 10 \^9/L. PR is All CR criteria if abnormal before treatment except \>/= 50% reduction in bone marrow blast but still \>5%. morphologic leukemia-free state is Bone marrow: \</=5% myeloblasts. HI is Hematologic response must be described by the number of positively affected cell lines.
Analysis population: There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Groups in this outcome
Arm 1 A Lead-In (Azacitidine, Nivolumab)
Patients receive azacitidine IV over 1 hour or SC on days 1-7 or days 1-4 and 7-9. Patients also receive nivolumab IV over 60 minutes on days 1 and 14 (courses 1-4) or on day 1 (course 5 and all subsequent courses). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Nivolumab: Given IV
Arm 1 B (Azacitidine, Nivolumab)
Patients receive azacitidine IV over 1 hour or SC on days 1-7 or days 1-4 and 7-9. Patients also receive nivolumab IV over 60 minutes on days 1 and 14 (courses 1-4) or on day 1 (course 5 and all subsequent courses). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Nivolumab: Given IV
Arm 2 A Lead-In (Azacitidine, Nivolumab, Ipilimumab)
Patients receive azacitidine and nivolumab as Arm I. Patients also receive ipilimumab IV over 90 minutes on day 1 and then every 6 or 12 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Ipilimumab Nivolumab: Given IV
Arm 2 B (Azacitidine, Nivolumab, Ipilimumab)
Patients receive azacitidine and nivolumab as Arm I. Patients also receive ipilimumab IV over 90 minutes on day 1 and then every 6 or 12 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Ipilimumab Nivolumab: Given IV
Arm 3 A Lead-In (Azacitidine, Nivolumab, Venetoclax)
Patients will receive therapy with nivolumab IV infusion on Day 8 and Day 22 (+/-3 days) of each 5-azacyidine cycle for first 4 cycles or until CR (whichever occurs earlier) followed by a maintenance regimen (one dose of nivolumab on Day 8 of each cycle of 5-azacytdine). Venetoclax will be administered orally daily on Days 1-21 of the first cycle; and Days 1-14 or Days 1-21 for subsequent cycles. Azacitidine: Given SC or IV Venetoclax: Given Orally Nivolumab: Given IV
| Group | Source count |
|---|---|
| Arm 1 A Lead-In (Azacitidine, Nivolumab) | 6 |
| Arm 1 B (Azacitidine, Nivolumab) | 85 |
| Arm 2 A Lead-In (Azacitidine, Nivolumab, Ipilimumab) | 6 |
| Arm 2 B (Azacitidine, Nivolumab, Ipilimumab) | 47 |
| Arm 3 A Lead-In (Azacitidine, Nivolumab, Venetoclax) | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm 1 A Lead-In (Azacitidine, Nivolumab) | 2 | Not reported | Not reported | Not reported | Not reported |
| Arm 1 B (Azacitidine, Nivolumab) | 34 | Not reported | Not reported | Not reported | Not reported |
| Arm 2 A Lead-In (Azacitidine, Nivolumab, Ipilimumab) | 2 | Not reported | Not reported | Not reported | Not reported |
| Arm 2 B (Azacitidine, Nivolumab, Ipilimumab) | 13 | Not reported | Not reported | Not reported | Not reported |
| Arm 3 A Lead-In (Azacitidine, Nivolumab, Venetoclax) | 4 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 34
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 13
- group Id
- OG004
- value
- 4
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 85
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 47
- group Id
- OG004
- value
- 6
- units
- Participants
- description
- Responders are patients who obtain a Complete Remission (CR), Complete Remission with Incomplete blood count recovery CRi, Complete Remission with Incomplete Platelet Recovery (CRp) or Partial Remission (PR), with or without cytogenetic response, hematologic improvements (HI), and morphologic leukemia-free state. CR is counts of 0 circulating blasts, Neutrophil count of \>/= 1.0 x 10\^9/L, Platelet count \>/= 100 x 10 \^9/L. Bone marrow \</= 5% blasts, No auer rods, No extramedullary disease. CRp is patients who have achieved a CR except for incomplete platelet recovery (\<100 x 10\^9/L). CRi is counts of 0 circulating blasts, Neutrophil count of \>/= 1.0 x 10\^9/L OR Platelet count \>/= 100 x 10 \^9/L. PR is All CR criteria if abnormal before treatment except \>/= 50% reduction in bone marrow blast but still \>5%. morphologic leukemia-free state is Bone marrow: \</=5% myeloblasts. HI is Hematologic response must be described by the number of positively affected cell lines.
- groups
- description
- Patients receive azacitidine IV over 1 hour or SC on days 1-7 or days 1-4 and 7-9. Patients also receive nivolumab IV over 60 minutes on days 1 and 14 (courses 1-4) or on day 1 (course 5 and all subsequent courses). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Nivolumab: Given IV
- id
- OG000
- title
- Arm 1 A Lead-In (Azacitidine, Nivolumab)
- description
- Patients receive azacitidine IV over 1 hour or SC on days 1-7 or days 1-4 and 7-9. Patients also receive nivolumab IV over 60 minutes on days 1 and 14 (courses 1-4) or on day 1 (course 5 and all subsequent courses). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Nivolumab: Given IV
- id
- OG001
- title
- Arm 1 B (Azacitidine, Nivolumab)
- description
- Patients receive azacitidine and nivolumab as Arm I. Patients also receive ipilimumab IV over 90 minutes on day 1 and then every 6 or 12 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Ipilimumab Nivolumab: Given IV
- id
- OG002
- title
- Arm 2 A Lead-In (Azacitidine, Nivolumab, Ipilimumab)
- description
- Patients receive azacitidine and nivolumab as Arm I. Patients also receive ipilimumab IV over 90 minutes on day 1 and then every 6 or 12 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Ipilimumab Nivolumab: Given IV
- id
- OG003
- title
- Arm 2 B (Azacitidine, Nivolumab, Ipilimumab)
- description
- Patients will receive therapy with nivolumab IV infusion on Day 8 and Day 22 (+/-3 days) of each 5-azacyidine cycle for first 4 cycles or until CR (whichever occurs earlier) followed by a maintenance regimen (one dose of nivolumab on Day 8 of each cycle of 5-azacytdine). Venetoclax will be administered orally daily on Days 1-21 of the first cycle; and Days 1-14 or Days 1-21 for subsequent cycles. Azacitidine: Given SC or IV Venetoclax: Given Orally Nivolumab: Given IV
- id
- OG004
- title
- Arm 3 A Lead-In (Azacitidine, Nivolumab, Venetoclax)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
- reporting Status
- POSTED
- time Frame
- Up to 7 years, 6 months
- title
- Participants With a Response
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice