TriangleNCT01564784 · OUTCOME
Duration of Remission (DoR) for Participants Who Achieved CR/CRi (Per Investigator Assessment)
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
- Up to 2 years from randomization
What was measured
DoR was defined as time from date of first response in responders (CR/CRi per Investigator assessment) to date of PFS event (i.e. death, progressive disease \[objective progression, relapse from CR/CRi or treatment discontinuation due to global deterioration of health status\] or starting new induction therapy or post-therapy stem cell transplant \[SCT\] without achieving CR/CRi). Responders without PFS events were censored at the last valid disease assessment including follow-up.
Analysis population: Participants in the ITT218 population who achieved CR/CRi
Groups in this outcome
Inotuzumab Ozogamicin
Participants were treated with inotuzumab ozogamicin at a starting dose of 1.8 mg/m\^2 (according to body surface area) per cycle with a divided-dose regimen using 3 weekly administrations. Participants received 0.8 mg/m\^2/cycle on Week 1 (Day 1), followed by 0.5 mg/m\^2 on Week 2 (Day 8) and Week 3 (Day 15) of a 21-day cycle, and administered as an intravenous infusion over 60 minutes. For participants who achieved a CR or CRi, or to allow recovery from toxicity, the length of Cycle 1 could be extended up to 28 days (ie, 1 week treatment-free interval starting on Day 21). For participants who achieved CR or CRi, the inotuzumab ozogamicin dose administered on Week 1 was reduced to 0.5 mg/m\^2 (for a total cycle dose of 1.5 mg/m\^2/cycle) for Cycles 2 through 6 (maximum number of cycles permitted). For Cycles 2 through 6, the cycle length was 28 days for all participants (regardless of remission status).
Defined Investigator's Choice of Chemotherapy
Participants received fludarabine, cytarabine, granulocyte-colony stimulating factor (FLAG), mitoxantrone + cytarabine (MXN/Ara-C), or high-dose cytarabine (HIDAC), according to the Investigator's choice.
| Group | Source count |
|---|---|
| Inotuzumab Ozogamicin | 85 |
| Defined Investigator's Choice of Chemotherapy | 32 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Inotuzumab Ozogamicin | 5.4 | Not reported | 4.3 | 8.0 | Not reported |
| Defined Investigator's Choice of Chemotherapy | 3.5 | Not reported | 2.2 | 6.6 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.297
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.809
- estimate Comment
- Stratified HR, i.e., based on analysis stratified by randomization stratification factors.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0021
- param Type
- Hazard Ratio (HR)
- param Value
- 0.490
- statistical Method
- 1-sided stratified log-rank p-value
Complete source fields
- analyses
- ci Lower Limit
- 0.297
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.809
- estimate Comment
- Stratified HR, i.e., based on analysis stratified by randomization stratification factors.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0021
- param Type
- Hazard Ratio (HR)
- param Value
- 0.490
- statistical Method
- 1-sided stratified log-rank p-value
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.3
- upper Limit
- 8.0
- value
- 5.4
- group Id
- OG001
- lower Limit
- 2.2
- upper Limit
- 6.6
- value
- 3.5
- denoms
- counts
- group Id
- OG000
- value
- 85
- group Id
- OG001
- value
- 32
- units
- Participants
- description
- DoR was defined as time from date of first response in responders (CR/CRi per Investigator assessment) to date of PFS event (i.e. death, progressive disease \[objective progression, relapse from CR/CRi or treatment discontinuation due to global deterioration of health status\] or starting new induction therapy or post-therapy stem cell transplant \[SCT\] without achieving CR/CRi). Responders without PFS events were censored at the last valid disease assessment including follow-up.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants were treated with inotuzumab ozogamicin at a starting dose of 1.8 mg/m\^2 (according to body surface area) per cycle with a divided-dose regimen using 3 weekly administrations. Participants received 0.8 mg/m\^2/cycle on Week 1 (Day 1), followed by 0.5 mg/m\^2 on Week 2 (Day 8) and Week 3 (Day 15) of a 21-day cycle, and administered as an intravenous infusion over 60 minutes. For participants who achieved a CR or CRi, or to allow recovery from toxicity, the length of Cycle 1 could be extended up to 28 days (ie, 1 week treatment-free interval starting on Day 21). For participants who achieved CR or CRi, the inotuzumab ozogamicin dose administered on Week 1 was reduced to 0.5 mg/m\^2 (for a total cycle dose of 1.5 mg/m\^2/cycle) for Cycles 2 through 6 (maximum number of cycles permitted). For Cycles 2 through 6, the cycle length was 28 days for all participants (regardless of remission status).
- id
- OG000
- title
- Inotuzumab Ozogamicin
- description
- Participants received fludarabine, cytarabine, granulocyte-colony stimulating factor (FLAG), mitoxantrone + cytarabine (MXN/Ara-C), or high-dose cytarabine (HIDAC), according to the Investigator's choice.
- id
- OG001
- title
- Defined Investigator's Choice of Chemotherapy
- param Type
- MEDIAN
- population Description
- Participants in the ITT218 population who achieved CR/CRi
- reporting Status
- POSTED
- time Frame
- Up to 2 years from randomization
- title
- Duration of Remission (DoR) for Participants Who Achieved CR/CRi (Per Investigator Assessment)
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice