TriangleNCT02113982 · OUTCOME
CR Rate in First-line BPDCN (Stage 3, Pivotal Cohort)
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
- at pre-defined treatment cycle intervals from randomization up to disease progression, up to 3.5 years
What was measured
Complete response (CR) rate, defined as the percentage who achieved CR+ CR(clinical) with minimal residual skin abnormality (CRc) after treatment with Tagraxofusp. CR criteria according to Cheson BD et al, The International Harmonization Project on Lymphoma. Revised response criteria for malignant lymphoma. J Clin Oncol 2007;25:579-586: Marrow: normalization of blast percentage (≤5%). Peripheral blood: normalization of neutrophil count (≥ 1,000/µL) and platelet count (≥ 100,000/µL) - absence of leukemic blasts Skin: 100% clearance of all skin lesions from baseline; no new lesions in patients without lesions at baseline Nodal masses: regression to normal size on CT Spleen, liver: not palpable, nodules disappeared CRc criteria: all the above except for skin: marked clearance of all skin lesions from baseline; residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed)
Analysis population: Pre-defined efficacy primary end point assessed in Stage 3, standalone, pivotal efficacy cohort of only patients with first-line BPDCN exposed to 12 μg/kg/day were enrolled.
Groups in this outcome
First-line BPDCN
First-line blastic plasmacytoid dendritic cell neoplasm (BPDCN) patients enrolled in stage 3
| Group | Source count |
|---|---|
| First-line BPDCN | 13 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| First-line BPDCN | 53.8 | Not reported | 25.1 | 80.8 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 25.1
- upper Limit
- 80.8
- value
- 53.8
- denoms
- counts
- group Id
- OG000
- value
- 13
- units
- Participants
- description
- Complete response (CR) rate, defined as the percentage who achieved CR+ CR(clinical) with minimal residual skin abnormality (CRc) after treatment with Tagraxofusp. CR criteria according to Cheson BD et al, The International Harmonization Project on Lymphoma. Revised response criteria for malignant lymphoma. J Clin Oncol 2007;25:579-586: Marrow: normalization of blast percentage (≤5%). Peripheral blood: normalization of neutrophil count (≥ 1,000/µL) and platelet count (≥ 100,000/µL) - absence of leukemic blasts Skin: 100% clearance of all skin lesions from baseline; no new lesions in patients without lesions at baseline Nodal masses: regression to normal size on CT Spleen, liver: not palpable, nodules disappeared CRc criteria: all the above except for skin: marked clearance of all skin lesions from baseline; residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed)
- dispersion Type
- 95% Confidence Interval
- groups
- description
- First-line blastic plasmacytoid dendritic cell neoplasm (BPDCN) patients enrolled in stage 3
- id
- OG000
- title
- First-line BPDCN
- param Type
- NUMBER
- population Description
- Pre-defined efficacy primary end point assessed in Stage 3, standalone, pivotal efficacy cohort of only patients with first-line BPDCN exposed to 12 μg/kg/day were enrolled.
- reporting Status
- POSTED
- time Frame
- at pre-defined treatment cycle intervals from randomization up to disease progression, up to 3.5 years
- title
- CR Rate in First-line BPDCN (Stage 3, Pivotal Cohort)
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice