TriangleNCT03386513 · OUTCOME
Duration of CR+CRc+CRh 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
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to approximately 81 months
What was measured
Duration of CR+CRc+CRh was defined as time from first response to time of relapse or death from any cause, whichever came first. CR: normalization of blast percentage (≤5%); normalization of neutrophil count (≥1000/μL) and platelet count (≥100,000/μL); absence of leukemic blasts; 100% clearance of all skin lesions from baseline; no new lesions; nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared. CRc: normalization of blast percentage (≤5%); normalization of neutrophil count (≥1000/μL) and 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. CRh: normalization of neutrophil count (≥ 500/μL) and platelet count (≥ 50,000/μL); other criteria same as defined for CRc.
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 with CR, CRc, and CRh. Per protocol, this endpoint evaluated only total R/R BPDCN participants with CR, CRc, and CRh, all of whom were in arm Schedule A: IMGN632 0.045 mg/kg.
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 | 5 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Total R/R BPDCN Participants - Schedule A: IMGN632 0.045 mg/kg | 9.20 | Not reported | 0.789 | NA | Data could not be calculated due to insufficient number of events. |
Complete source fields
- classes
- categories
- measurements
- comment
- Data could not be calculated due to insufficient number of events.
- group Id
- OG000
- lower Limit
- 0.789
- upper Limit
- NA
- value
- 9.20
- denoms
- counts
- group Id
- OG000
- value
- 5
- units
- Participants
- description
- Duration of CR+CRc+CRh was defined as time from first response to time of relapse or death from any cause, whichever came first. CR: normalization of blast percentage (≤5%); normalization of neutrophil count (≥1000/μL) and platelet count (≥100,000/μL); absence of leukemic blasts; 100% clearance of all skin lesions from baseline; no new lesions; nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared. CRc: normalization of blast percentage (≤5%); normalization of neutrophil count (≥1000/μL) and 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. CRh: normalization of neutrophil count (≥ 500/μL) and platelet count (≥ 50,000/μL); other criteria same as defined for CRc.
- 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 with CR, CRc, and CRh. Per protocol, this endpoint evaluated only total R/R BPDCN participants with CR, CRc, and CRh, all of whom were in arm Schedule A: IMGN632 0.045 mg/kg.
- reporting Status
- POSTED
- time Frame
- Up to approximately 81 months
- title
- Duration of CR+CRc+CRh As Assessed by Investigator in Total R/R BPDCN Participants
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice