TriangleNCT01207388 · OUTCOME
Duration of Complete MRD Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Until the data cut-off date of 05 August 2015; median time on study was 18.3 months.
What was measured
The duration of MRD response was analyzed as the time from onset of MRD negativity until MRD or hematological relapse or date of last confirmation of negative MRD status. Participants who received chemotherapy or HSCT after treatment with blinatumomab, before hematological or extramedullary relapse were censored at the start of chemotherapy or HSCT, respectively. MRD relapse is defined as the reappearance of individual rearrangements of Ig- or TCR-genes ≥ lower limit of quantification (LLOQ) for at least 1 individual marker measured by an assay with a sensitivity of minimum 10\^-4. Hematological relapse is defined as the unequivocal detection of \> 5% leukemia cells in bone marrow as measured by cytological or microscopic assessment, presence of circulating leukemia blasts, or extramedullary leukemia.
Analysis population: Full analysis set participants who were in hematological complete remission at treatment start, excluding Philadelphia-positive participants, who had an MRD complete response at cycle 1
Groups in this outcome
Blinatumomab
Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment.
| Group | Source count |
|---|---|
| Blinatumomab | 85 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Blinatumomab | 45.0 | Not reported | 6.5 | 45.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6.5
- upper Limit
- 45.0
- value
- 45.0
- denoms
- counts
- group Id
- OG000
- value
- 85
- units
- Participants
- description
- The duration of MRD response was analyzed as the time from onset of MRD negativity until MRD or hematological relapse or date of last confirmation of negative MRD status. Participants who received chemotherapy or HSCT after treatment with blinatumomab, before hematological or extramedullary relapse were censored at the start of chemotherapy or HSCT, respectively. MRD relapse is defined as the reappearance of individual rearrangements of Ig- or TCR-genes ≥ lower limit of quantification (LLOQ) for at least 1 individual marker measured by an assay with a sensitivity of minimum 10\^-4. Hematological relapse is defined as the unequivocal detection of \> 5% leukemia cells in bone marrow as measured by cytological or microscopic assessment, presence of circulating leukemia blasts, or extramedullary leukemia.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment.
- id
- OG000
- title
- Blinatumomab
- param Type
- MEDIAN
- population Description
- Full analysis set participants who were in hematological complete remission at treatment start, excluding Philadelphia-positive participants, who had an MRD complete response at cycle 1
- reporting Status
- POSTED
- time Frame
- Until the data cut-off date of 05 August 2015; median time on study was 18.3 months.
- title
- Duration of Complete MRD Response
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice