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NCT02399085 · OUTCOME

Time to Next Treatment (TTNT)

Open Label Study to Evaluate the Safety and Efficacy of Lenalidomide With MOR00208 in Patients With R-R DLBCL · Source last updated 2023-10-23

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 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled

What was measured

Kaplan-Meier analysis of TTNT in FAS population. TTNT is defined as the time from the first administration of any study drug to the institution of next anti-neoplastic therapy (for any reason including disease progression, treatment toxicity and participant preference) or death of any cause, whatever comes first.

Analysis population: FAS: The FAS includes all participants who received at least one dose of MOR00208 and one dose of LEN. This means that both study drugs must have been applied 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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Tafasitamab (MOR00208) + Lenalidomide (LEN)55

Reported measurements

Approximately 4.5 years after first participant enrolled

Analysis denominator · Participants

GroupSource count
Tafasitamab (MOR00208) + Lenalidomide (LEN)51
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Tafasitamab (MOR00208) + Lenalidomide (LEN)12.1Not reported7.324.7Not reported
Approximately 6.5 years after first participant enrolled

Analysis denominator · Participants

GroupSource count
Tafasitamab (MOR00208) + Lenalidomide (LEN)55
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Tafasitamab (MOR00208) + Lenalidomide (LEN)12.5Not reported7.328Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.3
        upper Limit
        24.7
        value
        12.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        51
      units
      Participants
    title
    Approximately 4.5 years after first participant enrolled
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.3
        upper Limit
        28
        value
        12.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        55
      units
      Participants
    title
    Approximately 6.5 years after first participant enrolled
denoms
  1. counts
    1. group Id
      OG000
      value
      55
    units
    Participants
description
Kaplan-Meier analysis of TTNT in FAS population. TTNT is defined as the time from the first administration of any study drug to the institution of next anti-neoplastic therapy (for any reason including disease progression, treatment toxicity and participant preference) or death of any cause, whatever comes first.
dispersion Type
95% Confidence Interval
groups
  1. 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 includes all participants who received at least one dose of MOR00208 and one dose of LEN. This means that both study drugs must have been applied at least once. Inclusive of participants with available data.
reporting Status
POSTED
time Frame
Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled
title
Time to Next Treatment (TTNT)
type
SECONDARY
unit Of Measure
Months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice