TriangleNCT04680052 · OUTCOME
FL Population: Progression-free Survival (PFS) by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented Disease Progression (PD), or Death From Any Cause, Whichever Occurred First
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 approximately 34 months
What was measured
PD, positron emission tomography (PET): score 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) for lymph node/extra lymphatic sites with increase in intensity of Baseline uptake and/or new fluorodeoxyglucose (FDG)-avid foci consistent with lymphoma at interim/end-of-treatment assessment; new/recurrent FDG-avid foci in bone marrow; new FDG-avid foci consistent with lymphoma versus other etiology in new lesions. PD, computed tomography (CT): abnormal individual node/lesion with longest diameter (LDi ) \>1.5 centimeters (cm) and increase by ≥50% from the product of the perpendicular diameters (PPD) nadir and increase in LDi or shortest diameter (SDi) from nadir; new/clear progression of preexisting nontarget lesions; new/recurrent splenomegaly and bone marrow involvement; regrowth of previously resolved lesions. New node \>1.5 cm in any axis. New extranodal site \>1.0 cm in any axis; if \<1.0 cm, presence is unequivocal and attributable to lymphoma.
Analysis population: Follicular Lymphoma (FL) Full Analysis Set: all randomized participants with FL. The 2-sided 95% confidence intervals were calculated using the method of Brookmeyer and Crowley with log-log transformation. Censored participants were included in the analysis.
Groups in this outcome
FL: Tafasitamab + Rituximab + Lenalidomide
Participants with follicular lymphoma (FL) were randomized to receive tafasitamab 12 milligrams per kilogram (mg/kg) intravenously (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 once daily (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/meters squared (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: Placebo + Rituximab + Lenalidomide
Participants with FL 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.
MZL: Tafasitamab + Rituximab + Lenalidomide
Participants with marginal zone lymphoma (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.
MZL: Placebo + Rituximab + Lenalidomide
Participants with 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: Tafasitamab + Rituximab + Lenalidomide | 273 |
| FL: Placebo + Rituximab + Lenalidomide | 275 |
| MZL: Tafasitamab + Rituximab + Lenalidomide | 0 |
| MZL: Placebo + Rituximab + Lenalidomide | 0 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| FL: Tafasitamab + Rituximab + Lenalidomide | 22.37 | Not reported | 19.22 | NA | The upper limit of the confidence interval was not estimable because too few participants had disease progression or died. |
| FL: Placebo + Rituximab + Lenalidomide | 13.93 | Not reported | 11.53 | 16.39 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
- group Id
- OG000
- lower Limit
- 19.22
- upper Limit
- NA
- value
- 22.37
- group Id
- OG001
- lower Limit
- 11.53
- upper Limit
- 16.39
- value
- 13.93
- denoms
- counts
- group Id
- OG000
- value
- 273
- group Id
- OG001
- value
- 275
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- units
- Participants
- description
- PD, positron emission tomography (PET): score 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) for lymph node/extra lymphatic sites with increase in intensity of Baseline uptake and/or new fluorodeoxyglucose (FDG)-avid foci consistent with lymphoma at interim/end-of-treatment assessment; new/recurrent FDG-avid foci in bone marrow; new FDG-avid foci consistent with lymphoma versus other etiology in new lesions. PD, computed tomography (CT): abnormal individual node/lesion with longest diameter (LDi ) \>1.5 centimeters (cm) and increase by ≥50% from the product of the perpendicular diameters (PPD) nadir and increase in LDi or shortest diameter (SDi) from nadir; new/clear progression of preexisting nontarget lesions; new/recurrent splenomegaly and bone marrow involvement; regrowth of previously resolved lesions. New node \>1.5 cm in any axis. New extranodal site \>1.0 cm in any axis; if \<1.0 cm, presence is unequivocal and attributable to lymphoma.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with follicular lymphoma (FL) were randomized to receive tafasitamab 12 milligrams per kilogram (mg/kg) intravenously (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 once daily (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/meters squared (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: Tafasitamab + Rituximab + Lenalidomide
- description
- Participants with FL 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: Placebo + Rituximab + Lenalidomide
- description
- Participants with marginal zone lymphoma (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
- OG002
- title
- MZL: Tafasitamab + Rituximab + Lenalidomide
- description
- Participants with 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
- OG003
- title
- MZL: Placebo + Rituximab + Lenalidomide
- param Type
- MEDIAN
- population Description
- Follicular Lymphoma (FL) Full Analysis Set: all randomized participants with FL. The 2-sided 95% confidence intervals were calculated using the method of Brookmeyer and Crowley with log-log transformation. Censored participants were included in the analysis.
- reporting Status
- POSTED
- time Frame
- up to approximately 34 months
- title
- FL Population: Progression-free Survival (PFS) by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented Disease Progression (PD), or Death From Any Cause, Whichever Occurred First
- type
- PRIMARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice