TriangleNCT02003222 · OUTCOME
RFS Among of Those Who Are MRD+ at Randomization and Then Convert to MRD- After 2 Cycles of Blinatumomab to Those Patients Who Are MRD- at Randomization and Remain MRD- After 2 Cycles of Blinatumomab or Consolidation Chemotherapy
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
- Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years
What was measured
RFS was defined as time from end of 2 cycles of blinatumomab to relapse or to death without documentation of relapse. Patients without events were censored at the date of last disease assessment. Relapse/Persistent Disease Persistent disease/Relapse following complete remission (CR)/complete remission incomplete (CRi) is defined as: * Reappearance or persistence of blasts in the blood * Presence of \> 5% blasts, not attributable to another cause (e.g., bone marrow regeneration). * In the case of isolated CNS relapse such as a positive cytospin examination of CSF, please consult with Study Chair. Perform bone marrow biopsy (if not already done) to confirm presence or lack of medullary relapse.
Analysis population: Patients with MRD data at the end of 2 cycles of blinatumomab were included in the analysis.
Groups in this outcome
MRD+ Then Convert to MRD-
Patients who are MRD positive (MRD+) at randomization/registration and then convert to MRD negative (MRD-) after 2 cycles of blinatumomab or consolidation chemotherapy. .
MRD- Then Remain MRD-
Patients who are MRD negative (MRD-) at randomization/registration and then remain MRD negative (MRD-) after 2 cycles of blinatumomab or consolidation chemotherapy. .
| Group | Source count |
|---|---|
| MRD+ Then Convert to MRD- | 28 |
| MRD- Then Remain MRD- | 89 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MRD+ Then Convert to MRD- | NA | Not reported | NA | NA | Median RFS not reached The 95% confidence intervals were not calculable because an insufficient number of participants reached the event at the final time point for assessment. |
| MRD- Then Remain MRD- | NA | Not reported | 38.9 | NA | Median RFS not reached The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment. |
Source statistical analyses
- ci Lower Limit
- 0.22
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.65
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.67
- param Type
- Hazard Ratio (HR)
- param Value
- 0.77
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.22
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.65
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.67
- param Type
- Hazard Ratio (HR)
- param Value
- 0.77
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- Median RFS not reached The 95% confidence intervals were not calculable because an insufficient number of participants reached the event at the final time point for assessment.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Median RFS not reached The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
- group Id
- OG001
- lower Limit
- 38.9
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 28
- group Id
- OG001
- value
- 89
- units
- Participants
- description
- RFS was defined as time from end of 2 cycles of blinatumomab to relapse or to death without documentation of relapse. Patients without events were censored at the date of last disease assessment. Relapse/Persistent Disease Persistent disease/Relapse following complete remission (CR)/complete remission incomplete (CRi) is defined as: * Reappearance or persistence of blasts in the blood * Presence of \> 5% blasts, not attributable to another cause (e.g., bone marrow regeneration). * In the case of isolated CNS relapse such as a positive cytospin examination of CSF, please consult with Study Chair. Perform bone marrow biopsy (if not already done) to confirm presence or lack of medullary relapse.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients who are MRD positive (MRD+) at randomization/registration and then convert to MRD negative (MRD-) after 2 cycles of blinatumomab or consolidation chemotherapy. .
- id
- OG000
- title
- MRD+ Then Convert to MRD-
- description
- Patients who are MRD negative (MRD-) at randomization/registration and then remain MRD negative (MRD-) after 2 cycles of blinatumomab or consolidation chemotherapy. .
- id
- OG001
- title
- MRD- Then Remain MRD-
- param Type
- MEDIAN
- population Description
- Patients with MRD data at the end of 2 cycles of blinatumomab were included in the analysis.
- reporting Status
- POSTED
- time Frame
- Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years
- title
- RFS Among of Those Who Are MRD+ at Randomization and Then Convert to MRD- After 2 Cycles of Blinatumomab to Those Patients Who Are MRD- at Randomization and Remain MRD- After 2 Cycles of Blinatumomab or Consolidation Chemotherapy
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice