TriangleNCT02927938 · OUTCOME
2 Year Relapse Free Survival (RFS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- 2 years
What was measured
Comparison of 2 year RFS in patient with detectable LSCs in the marrow at the end of consolidation to the 2 year RFS of patients without detectable LSCs. IWG Criteria (Cheson 2003) was utilized to classify relapse, with relapse defined as ≥ 5% blasts in the marrow or peripheral blood, extramedullary disease, or disease presence determined by a physician upon clinical assessment.
Analysis population: The primary efficacy analyses will be conducted on the subset of subjects who were included in the evaluable cohort (HCT or chemo treatment arm) and who also had a successful/interpretable end of consolidation eLSC assay. This excludes subjects in OC1 and 2, as they did not achieve CR to induction or did not have the immunophenotype of interest.
Groups in this outcome
eLSC+ (Evaluable Cohort)
Of the subjects enrolled in the evaluable cohort (either allo HCT or consolidation chemotherapy), those who had leukemia stem cells detected post-consolidation. Note, eLSC indicates the time point after consolidation.
eLSC- (Evaluable Cohort)
Of the subjects enrolled in the evaluable cohort (either allo HCT or consolidation chemotherapy), those who had leukemia stem cells not detected post-consolidation. Note, eLSC indicates the time point after consolidation.
| Group | Source count |
|---|---|
| eLSC+ (Evaluable Cohort) | 0 |
| eLSC- (Evaluable Cohort) | 5 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| eLSC- (Evaluable Cohort) | NA | Not reported | Not reported | Not reported | Study terminated early, with immature outcome data. There was not enough follow up to determine 2-year RFS status for these subjects prior to study termination. |
Complete source fields
- classes
- categories
- measurements
- comment
- Study terminated early, with immature outcome data. There was not enough follow up to determine 2-year RFS status for these subjects prior to study termination.
- group Id
- OG001
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 5
- units
- Participants
- description
- Comparison of 2 year RFS in patient with detectable LSCs in the marrow at the end of consolidation to the 2 year RFS of patients without detectable LSCs. IWG Criteria (Cheson 2003) was utilized to classify relapse, with relapse defined as ≥ 5% blasts in the marrow or peripheral blood, extramedullary disease, or disease presence determined by a physician upon clinical assessment.
- groups
- description
- Of the subjects enrolled in the evaluable cohort (either allo HCT or consolidation chemotherapy), those who had leukemia stem cells detected post-consolidation. Note, eLSC indicates the time point after consolidation.
- id
- OG000
- title
- eLSC+ (Evaluable Cohort)
- description
- Of the subjects enrolled in the evaluable cohort (either allo HCT or consolidation chemotherapy), those who had leukemia stem cells not detected post-consolidation. Note, eLSC indicates the time point after consolidation.
- id
- OG001
- title
- eLSC- (Evaluable Cohort)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The primary efficacy analyses will be conducted on the subset of subjects who were included in the evaluable cohort (HCT or chemo treatment arm) and who also had a successful/interpretable end of consolidation eLSC assay. This excludes subjects in OC1 and 2, as they did not achieve CR to induction or did not have the immunophenotype of interest.
- reporting Status
- POSTED
- time Frame
- 2 years
- title
- 2 Year Relapse Free Survival (RFS)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice