TriangleNCT02399085 · OUTCOME
TTP by INV Evaluation
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
- Approximately 2.5 years after first participant enrolled
What was measured
TTP is defined as the time from the first administration of any study drug until documented DLBCL progression or death as a result of lymphoma.
Analysis population: FAS: The FAS included all participants who received at least one dose of MOR00208 and at least one dose of LEN. This meant that both study drugs had to be administered at least once. Inclusive of participants with available data.
Groups in this outcome
Tafasitamab (MOR00208) + Lenalidomide (LEN)
MOR00208: MOR00208 was administered via IV infusion at a dose of 12 mg/kg. For the first three cycles (Cycles 1 to 3) of the study each cycle consisted of a MOR00208 infusion on Day 1, Day 8, Day 15 and Day 22 of the cycle. Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter MOR00208 was administered on a bi-weekly (every 14 days) basis with infusions on Day 1 and Day 15 of each 28-day cycle. LEN: Participants self-administered a starting dose of 25 mg oral LEN daily on Days 1-21 of each cycle, for up to 12 cycles in total. LEN dose could be modified in a de-escalating fashion or discontinued based upon clinical and laboratory findings. On days when both study drugs were given together, LEN was administered prior to MOR00208.
| Group | Source count |
|---|---|
| Tafasitamab (MOR00208) + Lenalidomide (LEN) | 40 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Tafasitamab (MOR00208) + Lenalidomide (LEN) | 14.1 | Not reported | 6.3 | NA | Not available. Upper limit not reached due to insufficient number of events at later stages of follow-up. |
Complete source fields
- classes
- categories
- measurements
- comment
- Not available. Upper limit not reached due to insufficient number of events at later stages of follow-up.
- group Id
- OG000
- lower Limit
- 6.3
- upper Limit
- NA
- value
- 14.1
- denoms
- counts
- group Id
- OG000
- value
- 40
- units
- Participants
- description
- TTP is defined as the time from the first administration of any study drug until documented DLBCL progression or death as a result of lymphoma.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- MOR00208: MOR00208 was administered via IV infusion at a dose of 12 mg/kg. For the first three cycles (Cycles 1 to 3) of the study each cycle consisted of a MOR00208 infusion on Day 1, Day 8, Day 15 and Day 22 of the cycle. Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter MOR00208 was administered on a bi-weekly (every 14 days) basis with infusions on Day 1 and Day 15 of each 28-day cycle. LEN: Participants self-administered a starting dose of 25 mg oral LEN daily on Days 1-21 of each cycle, for up to 12 cycles in total. LEN dose could be modified in a de-escalating fashion or discontinued based upon clinical and laboratory findings. On days when both study drugs were given together, LEN was administered prior to MOR00208.
- id
- OG000
- title
- Tafasitamab (MOR00208) + Lenalidomide (LEN)
- param Type
- MEDIAN
- population Description
- FAS: The FAS included all participants who received at least one dose of MOR00208 and at least one dose of LEN. This meant that both study drugs had to be administered at least once. Inclusive of participants with available data.
- reporting Status
- POSTED
- time Frame
- Approximately 2.5 years after first participant enrolled
- title
- TTP by INV Evaluation
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice