TriangleNCT00549848 · OUTCOME
Proportion of Participants With Minimal Residual Disease (MRD) on the 15th Day of Remission Induction ≥ 5%
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
- Middle of remission induction, Day 15 in Total XVI and Day 19 in Total XV
What was measured
To study whether intensifying induction, including fractionated cyclophosphamide and thioguanine, in patients with day 15 MRD ≥ 5% will result in improved leukemia cytoreduction in this subgroup compared to therapy followed in the TOTXV protocol.
Analysis population: The analysis will compare the proportion of TOTXV patients who had Day-19 MRD≥5% with the proportion of patients on TOTXVI with Day-15 MRD≥5%.
Groups in this outcome
TOTXVI PEG 3500
Patients randomized on the first day of continuation phase to receive 3500 units/m\^2 dose of PEG-asparaginase
TOTXVI PEG 2500
Patients randomized on the first day of continuation phase to receive 2,500 units/m\^2 dose of PEG-asparaginase
TOTXVI Not Randomized
Patients who came off study prior to randomization
All Eligible Patients in TOTXV
Eligible Patients in TOTXV
| Group | Source count |
|---|---|
| TOTXVI PEG 3500 | 203 |
| TOTXVI PEG 2500 | 206 |
| TOTXVI Not Randomized | 183 |
| All Eligible Patients in TOTXV | 488 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| TOTXVI PEG 3500 | 22 | Not reported | Not reported | Not reported | Not reported |
| TOTXVI PEG 2500 | 26 | Not reported | Not reported | Not reported | Not reported |
| TOTXVI Not Randomized | 31 | Not reported | Not reported | Not reported | Not reported |
| All Eligible Patients in TOTXV | 55 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 22
- group Id
- OG001
- value
- 26
- group Id
- OG002
- value
- 31
- group Id
- OG003
- value
- 55
- denoms
- counts
- group Id
- OG000
- value
- 203
- group Id
- OG001
- value
- 206
- group Id
- OG002
- value
- 183
- group Id
- OG003
- value
- 488
- units
- Participants
- description
- To study whether intensifying induction, including fractionated cyclophosphamide and thioguanine, in patients with day 15 MRD ≥ 5% will result in improved leukemia cytoreduction in this subgroup compared to therapy followed in the TOTXV protocol.
- groups
- description
- Patients randomized on the first day of continuation phase to receive 3500 units/m\^2 dose of PEG-asparaginase
- id
- OG000
- title
- TOTXVI PEG 3500
- description
- Patients randomized on the first day of continuation phase to receive 2,500 units/m\^2 dose of PEG-asparaginase
- id
- OG001
- title
- TOTXVI PEG 2500
- description
- Patients who came off study prior to randomization
- id
- OG002
- title
- TOTXVI Not Randomized
- description
- Eligible Patients in TOTXV
- id
- OG003
- title
- All Eligible Patients in TOTXV
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The analysis will compare the proportion of TOTXV patients who had Day-19 MRD≥5% with the proportion of patients on TOTXVI with Day-15 MRD≥5%.
- reporting Status
- POSTED
- time Frame
- Middle of remission induction, Day 15 in Total XVI and Day 19 in Total XV
- title
- Proportion of Participants With Minimal Residual Disease (MRD) on the 15th Day of Remission Induction ≥ 5%
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice