TriangleNCT04680052 · OUTCOME
FDG-avid Overall Population: PET-CR Rate by Investigator Assessment, Using the Lugano 2014 Criteria
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 34 months
What was measured
CR was defined as a complete metabolic response at any time after the start of treatment. Per PET, CR criteria: (1) score of 1, 2, or 3 with or without a residual mass on a 5-point scale for lymph nodes and extralymphatic sites; (2) No evidence of FDG-avid disease in bone marrow; and (3) no new lesions. PET 5-point scale: 1 = no uptake above background; 2 = uptake ≤ mediastinum; 3 = uptake \> mediastinum but ≤ liver; 4 = uptake moderately \> liver; 5 = uptake markedly higher than liver and/or new lesions; X = new areas of uptake unlikely to be related to lymphoma. The Overall FDG-avid Set included all randomized participants with a PET scan at Baseline with a resulting Deauville score of 4 or 5.
Analysis population: Overall FDG-avid Set. As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Participants who did not have a post-baseline PET scan were considered to be "not assessed," but were included in the analysis. The 95% confidence intervals were calculated using the Clopper-Pearson method.
Groups in this outcome
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
Participants with FL and MZL were randomized to receive tafasitamab 12 mg/kg IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
FL and MZL: Placebo + Rituximab + Lenalidomide
Participants with FL and MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
| Group | Source count |
|---|---|
| FL and MZL: Tafasitamab + Rituximab + Lenalidomide | 290 |
| FL and MZL: Placebo + Rituximab + Lenalidomide | 293 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| FL and MZL: Tafasitamab + Rituximab + Lenalidomide | 50.7 | Not reported | 44.78 | 56.58 | Not reported |
| FL and MZL: Placebo + Rituximab + Lenalidomide | 41.3 | Not reported | 35.60 | 47.17 | Not reported |
Source statistical analyses
- ci Lower Limit
- 1.06
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.03
- estimate Comment
- The strata information was based on the data obtained from the interactive response technology that was used for randomization.
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0221
- param Type
- Odds Ratio (OR)
- param Value
- 1.5
- statistical Method
- stratified Cochran-Mantel-Haenszel
Complete source fields
- analyses
- ci Lower Limit
- 1.06
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.03
- estimate Comment
- The strata information was based on the data obtained from the interactive response technology that was used for randomization.
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0221
- param Type
- Odds Ratio (OR)
- param Value
- 1.5
- statistical Method
- stratified Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 44.78
- upper Limit
- 56.58
- value
- 50.7
- group Id
- OG001
- lower Limit
- 35.60
- upper Limit
- 47.17
- value
- 41.3
- denoms
- counts
- group Id
- OG000
- value
- 290
- group Id
- OG001
- value
- 293
- units
- Participants
- description
- CR was defined as a complete metabolic response at any time after the start of treatment. Per PET, CR criteria: (1) score of 1, 2, or 3 with or without a residual mass on a 5-point scale for lymph nodes and extralymphatic sites; (2) No evidence of FDG-avid disease in bone marrow; and (3) no new lesions. PET 5-point scale: 1 = no uptake above background; 2 = uptake ≤ mediastinum; 3 = uptake \> mediastinum but ≤ liver; 4 = uptake moderately \> liver; 5 = uptake markedly higher than liver and/or new lesions; X = new areas of uptake unlikely to be related to lymphoma. The Overall FDG-avid Set included all randomized participants with a PET scan at Baseline with a resulting Deauville score of 4 or 5.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with FL and MZL were randomized to receive tafasitamab 12 mg/kg IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
- id
- OG000
- title
- FL and MZL: Tafasitamab + Rituximab + Lenalidomide
- description
- Participants with FL and MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
- id
- OG001
- title
- FL and MZL: Placebo + Rituximab + Lenalidomide
- param Type
- NUMBER
- population Description
- Overall FDG-avid Set. As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Participants who did not have a post-baseline PET scan were considered to be "not assessed," but were included in the analysis. The 95% confidence intervals were calculated using the Clopper-Pearson method.
- reporting Status
- POSTED
- time Frame
- up to approximately 34 months
- title
- FDG-avid Overall Population: PET-CR Rate by Investigator Assessment, Using the Lugano 2014 Criteria
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice