TriangleNCT01564784 · OUTCOME
Percentage of Participants Achieving MRD Negativity (Based on Central Laboratory Analysis) in Participants Achieving a CR/CRi (Per EAC Assessment)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of Participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to approximately 4 weeks (EoT) from last dose of study drug
What was measured
MRD analysis was performed at least once in participants with prior assessment of CR or CRi. Bone marrow aspirates, collected at screening and during the study, were sent to the central laboratory and analyzed using multiparametric flow cytometry. The antibody combinations were designed to maximize discrimination between normal and abnormal cells of B-cell lineage and similar maturational stage and included antibodies detecting cluster of differentiation (CD) 9, CD10, CD13, CD19, CD20, CD33, CD34, CD38, CD45, CD58, CD66c, and CD123. A peripheral blood sample was provided if a participant had an inadequate bone marrow aspirate at screening. MRD negativity was considered to have been achieved if the lowest value of MRD from the first date of CR/CRi to EoT was \<1 × 10\^-4 blasts/nucleated cells.
Analysis population: Participants in the ITT218 population achieving CR/CRi (per EAC Assessment)
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 | 88 |
| Defined Investigator's Choice of Chemotherapy | 32 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Inotuzumab Ozogamicin | 78.4 | Not reported | 68.4 | 86.5 | Not reported |
| Defined Investigator's Choice of Chemotherapy | 28.1 | Not reported | 13.7 | 46.7 | Not reported |
Source statistical analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0001
- statistical Comment
- If any cell count is \<5, p-value was based on Fisher's exact test
- statistical Method
- 1-sided p-value based on Chi-Square test
Complete source fields
- analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0001
- statistical Comment
- If any cell count is \<5, p-value was based on Fisher's exact test
- statistical Method
- 1-sided p-value based on Chi-Square test
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 68.4
- upper Limit
- 86.5
- value
- 78.4
- group Id
- OG001
- lower Limit
- 13.7
- upper Limit
- 46.7
- value
- 28.1
- denoms
- counts
- group Id
- OG000
- value
- 88
- group Id
- OG001
- value
- 32
- units
- Participants
- description
- MRD analysis was performed at least once in participants with prior assessment of CR or CRi. Bone marrow aspirates, collected at screening and during the study, were sent to the central laboratory and analyzed using multiparametric flow cytometry. The antibody combinations were designed to maximize discrimination between normal and abnormal cells of B-cell lineage and similar maturational stage and included antibodies detecting cluster of differentiation (CD) 9, CD10, CD13, CD19, CD20, CD33, CD34, CD38, CD45, CD58, CD66c, and CD123. A peripheral blood sample was provided if a participant had an inadequate bone marrow aspirate at screening. MRD negativity was considered to have been achieved if the lowest value of MRD from the first date of CR/CRi to EoT was \<1 × 10\^-4 blasts/nucleated cells.
- 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
- NUMBER
- population Description
- Participants in the ITT218 population achieving CR/CRi (per EAC Assessment)
- reporting Status
- POSTED
- time Frame
- Up to approximately 4 weeks (EoT) from last dose of study drug
- title
- Percentage of Participants Achieving MRD Negativity (Based on Central Laboratory Analysis) in Participants Achieving a CR/CRi (Per EAC Assessment)
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
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Preserved source evidence · Not medical advice