TriangleNCT03386513 · OUTCOME
ORR As Assessed by Investigator in Total R/R BPDCN Participants
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: percentage of participants with CR, CRc, CRh, CRi, and PR. CR, CRc, and CRh as defined in Outcome Measure 20 above. CRi: normalization of blast percentage (≤5%); normalization of neutrophil count (≥1000/μL) or platelet count (≥100,000/μL); absence of leukemic blasts; marked clearance of all skin lesions from baseline, residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed); nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared. PR: Decreased by \> 50% in blast percentage to 5%-25%; 50% to \<100% clearance of all skin lesions from baseline; no new lesions in participants without lesions at baseline; ≥50% decrease in the sum of the product of the diameters (SPD) of up to 6 largest dominant masses, no increase in size of other nodes; ≥ 50% decrease in SPD of nodules (for single nodule in greatest transverse diameter), no increase in size of liver of spleen.
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' = Total R/R BPDCN participants.
Groups in this outcome
Total R/R BPDCN Participants - Schedule A: IMGN632 0.045 mg/kg
Participants received IMGN632 via IV infusion on Day 1 of each 21-day cycle.
| Group | Source count |
|---|---|
| Total R/R BPDCN Participants - Schedule A: IMGN632 0.045 mg/kg | 51 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Total R/R BPDCN Participants - Schedule A: IMGN632 0.045 mg/kg | 35.3 | Not reported | 22.43 | 49.93 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 22.43
- upper Limit
- 49.93
- value
- 35.3
- denoms
- counts
- group Id
- OG000
- value
- 51
- units
- Participants
- description
- ORR: percentage of participants with CR, CRc, CRh, CRi, and PR. CR, CRc, and CRh as defined in Outcome Measure 20 above. CRi: normalization of blast percentage (≤5%); normalization of neutrophil count (≥1000/μL) or platelet count (≥100,000/μL); absence of leukemic blasts; marked clearance of all skin lesions from baseline, residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed); nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared. PR: Decreased by \> 50% in blast percentage to 5%-25%; 50% to \<100% clearance of all skin lesions from baseline; no new lesions in participants without lesions at baseline; ≥50% decrease in the sum of the product of the diameters (SPD) of up to 6 largest dominant masses, no increase in size of other nodes; ≥ 50% decrease in SPD of nodules (for single nodule in greatest transverse diameter), no increase in size of liver of spleen.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received IMGN632 via IV infusion on Day 1 of each 21-day cycle.
- id
- OG000
- title
- Total R/R BPDCN Participants - Schedule A: IMGN632 0.045 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' = Total R/R BPDCN participants.
- reporting Status
- POSTED
- time Frame
- Up to approximately 81 months
- title
- ORR As Assessed by Investigator in Total R/R BPDCN Participants
- 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