TriangleNCT03386513 · OUTCOME
Composite Complete Remission/Response (CCR) Rate As Assessed by Investigator in Frontline De Novo Blastic Plasmacytoid Dendritic Cell Neoplasm (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
CCR rate was defined as percentage of participants with complete remission/response (CR) and clinical complete remission (CRc). CR was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/microliter \[μL\]) and platelet count (≥ 100,000/μL); absence of leukemic blasts; 100% clearance of all skin lesions from baseline; no new lesions in participants without lesions at baseline; nodal masses regression to normal size on computed tomography (CT); and spleen and liver not palpable and nodules disappeared. CRc was defined as 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.
Analysis population: Modified Intent-to-treat (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' = Frontline de novo BPDCN participants. Per protocol, this endpoint evaluated only Frontline De Novo BPDCN Participants, all of whom were in arm Schedule A: IMGN632 0.045 mg/kg.
Groups in this outcome
Frontline De Novo 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 |
|---|---|
| Frontline De Novo BPDCN Participants - Schedule A: IMGN632 0.045 mg/kg | 22 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Frontline De Novo BPDCN Participants - Schedule A: IMGN632 0.045 mg/kg | 72.7 | Not reported | 49.78 | 89.27 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 49.78
- upper Limit
- 89.27
- value
- 72.7
- denoms
- counts
- group Id
- OG000
- value
- 22
- units
- Participants
- description
- CCR rate was defined as percentage of participants with complete remission/response (CR) and clinical complete remission (CRc). CR was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/microliter \[μL\]) and platelet count (≥ 100,000/μL); absence of leukemic blasts; 100% clearance of all skin lesions from baseline; no new lesions in participants without lesions at baseline; nodal masses regression to normal size on computed tomography (CT); and spleen and liver not palpable and nodules disappeared. CRc was defined as 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.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received IMGN632 via IV infusion on Day 1 of each 21-day cycle.
- id
- OG000
- title
- Frontline De Novo BPDCN Participants - Schedule A: IMGN632 0.045 mg/kg
- param Type
- NUMBER
- population Description
- Modified Intent-to-treat (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' = Frontline de novo BPDCN participants. Per protocol, this endpoint evaluated only Frontline De Novo BPDCN Participants, all of whom were in arm Schedule A: IMGN632 0.045 mg/kg.
- reporting Status
- POSTED
- time Frame
- Up to approximately 81 months
- title
- Composite Complete Remission/Response (CCR) Rate As Assessed by Investigator in Frontline De Novo Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) Participants
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice