TriangleNCT03386513 · OUTCOME
Dose Escalation Phase: Overall Response Rate (ORR), As Assessed by Investigator in Participants With 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
- Up to approximately 81 months
What was measured
ORR was defined as percentage of participants with CR without minimal residual disease (CRMRD-), CR, CR with partial hematologic recovery (CRh), CR with incomplete recovery (CRi), morphologic leukemia-free state (MLFS), or partial response (PR). CRMRD-: CR with negativity for a genetic marker. CR: Morphologic CR \<5% blasts; Absolute neutrophil count (ANC) \>1000/μL; Platelets ≥100,000/μL; Participant independent of transfusions; No residual evidence of active extramedullary disease; MRD+ or unknown. CRh: Met requirements for CR except ANC \>500/μL and platelets \>50,000/μL. CRi: Met requirements for CR except either ANC \<1000/μL or platelets \<100,000/μL. MLFS: Bone marrow \<5% blasts in an aspirate with spicules; No blasts with Auer rods or persistence of extramedullary disease; Marrow not "aplastic"; ≥200 cells should be enumerated or cellularity should be ≥10%. PR: Decrease of ≥50% in percentage of blasts to 5% to 25% in bone marrow aspirate (BMA) and normalization of blood counts.
Analysis population: mITT Population included all participants who were eligible based on the screening criteria and who received at least 1 dose of study drug. Here, 'Overall number of participants analyzed' = participants with AML in Dose Escalation Phase only.
Groups in this outcome
Dose Escalation - Schedule A: IMGN632 0.015 mg/kg
Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Day 1 of each 21-day cycle.
Dose Escalation - Schedule A: IMGN632 0.045 mg/kg
Participants received IMGN632 at a dose of 0.045 mg/kg via IV infusion on Day 1 of each 21-day cycle.
Dose Escalation - Schedule A: IMGN632 0.09 mg/kg
Participants received IMGN632 at a dose of 0.09 mg/kg via IV infusion on Day 1 of each 21-day cycle.
Dose Escalation - Schedule A: IMGN632 0.18 mg/kg
Participants received IMGN632 at a dose of 0.18 mg/kg via IV infusion on Day 1 of each 21-day cycle.
Dose Escalation - Schedule A: IMGN632 0.3 mg/kg
Participants received IMGN632 at a dose of 0.3 mg/kg via IV infusion on Day 1 of each 21-day cycle.
Dose Escalation - Schedule A: IMGN632 0.45 mg/kg
Participants received IMGN632 at a dose of 0.45 mg/kg via IV infusion on Day 1 of each 21-day cycle.
Dose Escalation - Schedule B: IMGN632 0.015 mg/kg
Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.
Dose Escalation - Schedule B: IMGN632 0.03 mg/kg
Participants received IMGN632 at a dose of 0.03 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.
Dose Escalation - Schedule B: IMGN632 0.06 mg/kg
Participants received IMGN632 at a dose of 0.06 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.
| Group | Source count |
|---|---|
| Dose Escalation - Schedule A: IMGN632 0.015 mg/kg | 3 |
| Dose Escalation - Schedule A: IMGN632 0.045 mg/kg | 9 |
| Dose Escalation - Schedule A: IMGN632 0.09 mg/kg | 12 |
| Dose Escalation - Schedule A: IMGN632 0.18 mg/kg | 7 |
| Dose Escalation - Schedule A: IMGN632 0.3 mg/kg | 5 |
| Dose Escalation - Schedule A: IMGN632 0.45 mg/kg | 2 |
| Dose Escalation - Schedule B: IMGN632 0.015 mg/kg | 3 |
| Dose Escalation - Schedule B: IMGN632 0.03 mg/kg | 6 |
| Dose Escalation - Schedule B: IMGN632 0.06 mg/kg | 14 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation - Schedule A: IMGN632 0.015 mg/kg | 33.3 | Not reported | 0.84 | 90.57 | Not reported |
| Dose Escalation - Schedule A: IMGN632 0.045 mg/kg | 22.2 | Not reported | 2.81 | 60.01 | Not reported |
| Dose Escalation - Schedule A: IMGN632 0.09 mg/kg | 8.3 | Not reported | 0.21 | 38.48 | Not reported |
| Dose Escalation - Schedule A: IMGN632 0.18 mg/kg | 14.3 | Not reported | 0.36 | 57.87 | Not reported |
| Dose Escalation - Schedule A: IMGN632 0.3 mg/kg | 20.0 | Not reported | 0.51 | 71.64 | Not reported |
| Dose Escalation - Schedule A: IMGN632 0.45 mg/kg | 0 | Not reported | 0.0 | 84.19 | Not reported |
| Dose Escalation - Schedule B: IMGN632 0.015 mg/kg | 0 | Not reported | 0.00 | 70.76 | Not reported |
| Dose Escalation - Schedule B: IMGN632 0.03 mg/kg | 16.7 | Not reported | 0.42 | 64.12 | Not reported |
| Dose Escalation - Schedule B: IMGN632 0.06 mg/kg | 7.1 | Not reported | 0.18 | 33.87 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.84
- upper Limit
- 90.57
- value
- 33.3
- group Id
- OG001
- lower Limit
- 2.81
- upper Limit
- 60.01
- value
- 22.2
- group Id
- OG002
- lower Limit
- 0.21
- upper Limit
- 38.48
- value
- 8.3
- group Id
- OG003
- lower Limit
- 0.36
- upper Limit
- 57.87
- value
- 14.3
- group Id
- OG004
- lower Limit
- 0.51
- upper Limit
- 71.64
- value
- 20.0
- group Id
- OG005
- lower Limit
- 0.0
- upper Limit
- 84.19
- value
- 0
- group Id
- OG006
- lower Limit
- 0.00
- upper Limit
- 70.76
- value
- 0
- group Id
- OG007
- lower Limit
- 0.42
- upper Limit
- 64.12
- value
- 16.7
- group Id
- OG008
- lower Limit
- 0.18
- upper Limit
- 33.87
- value
- 7.1
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 12
- group Id
- OG003
- value
- 7
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 6
- group Id
- OG008
- value
- 14
- units
- Participants
- description
- ORR was defined as percentage of participants with CR without minimal residual disease (CRMRD-), CR, CR with partial hematologic recovery (CRh), CR with incomplete recovery (CRi), morphologic leukemia-free state (MLFS), or partial response (PR). CRMRD-: CR with negativity for a genetic marker. CR: Morphologic CR \<5% blasts; Absolute neutrophil count (ANC) \>1000/μL; Platelets ≥100,000/μL; Participant independent of transfusions; No residual evidence of active extramedullary disease; MRD+ or unknown. CRh: Met requirements for CR except ANC \>500/μL and platelets \>50,000/μL. CRi: Met requirements for CR except either ANC \<1000/μL or platelets \<100,000/μL. MLFS: Bone marrow \<5% blasts in an aspirate with spicules; No blasts with Auer rods or persistence of extramedullary disease; Marrow not "aplastic"; ≥200 cells should be enumerated or cellularity should be ≥10%. PR: Decrease of ≥50% in percentage of blasts to 5% to 25% in bone marrow aspirate (BMA) and normalization of blood counts.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Day 1 of each 21-day cycle.
- id
- OG000
- title
- Dose Escalation - Schedule A: IMGN632 0.015 mg/kg
- description
- Participants received IMGN632 at a dose of 0.045 mg/kg via IV infusion on Day 1 of each 21-day cycle.
- id
- OG001
- title
- Dose Escalation - Schedule A: IMGN632 0.045 mg/kg
- description
- Participants received IMGN632 at a dose of 0.09 mg/kg via IV infusion on Day 1 of each 21-day cycle.
- id
- OG002
- title
- Dose Escalation - Schedule A: IMGN632 0.09 mg/kg
- description
- Participants received IMGN632 at a dose of 0.18 mg/kg via IV infusion on Day 1 of each 21-day cycle.
- id
- OG003
- title
- Dose Escalation - Schedule A: IMGN632 0.18 mg/kg
- description
- Participants received IMGN632 at a dose of 0.3 mg/kg via IV infusion on Day 1 of each 21-day cycle.
- id
- OG004
- title
- Dose Escalation - Schedule A: IMGN632 0.3 mg/kg
- description
- Participants received IMGN632 at a dose of 0.45 mg/kg via IV infusion on Day 1 of each 21-day cycle.
- id
- OG005
- title
- Dose Escalation - Schedule A: IMGN632 0.45 mg/kg
- description
- Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.
- id
- OG006
- title
- Dose Escalation - Schedule B: IMGN632 0.015 mg/kg
- description
- Participants received IMGN632 at a dose of 0.03 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.
- id
- OG007
- title
- Dose Escalation - Schedule B: IMGN632 0.03 mg/kg
- description
- Participants received IMGN632 at a dose of 0.06 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.
- id
- OG008
- title
- Dose Escalation - Schedule B: IMGN632 0.06 mg/kg
- param Type
- NUMBER
- population Description
- mITT Population included all participants who were eligible based on the screening criteria and who received at least 1 dose of study drug. Here, 'Overall number of participants analyzed' = participants with AML in Dose Escalation Phase only.
- reporting Status
- POSTED
- time Frame
- Up to approximately 81 months
- title
- Dose Escalation Phase: Overall Response Rate (ORR), As Assessed by Investigator in Participants With AML
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice