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NCT02399085 · OUTCOME

Number of Participants Who Developed Anti-MOR00208 Antibodies

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Baseline, Up to a maximum of 23 cycles.

What was measured

The Anti-MOR00208 Antibodies were investigated by quantifying serum drug levels at baseline and after repeated intravenous (IV) administrations planned for up to 24 treatment cycles using sparse sampling. Anti-MOR00208 antibody sample (pre-dose only) were taken in odd numbered additional treatment cycles only (e.g., treatment Cycles 13, 15,17, 19, 21,23).

Analysis population: Immunogenicity analysis set (IAS): The IAS included participants who had at least one anti-MOR00208 antibody assessment.

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)81

Reported measurements

Source class 1

Yes (Treatment-emergent ADAs)

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tafasitamab (MOR00208) + Lenalidomide (LEN)0Not reportedNot reportedNot reportedNot reported

No (Negative baseline and post baseline results)

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tafasitamab (MOR00208) + Lenalidomide (LEN)72Not reportedNot reportedNot reportedNot reported

Not evaluable (Positive baseline results)

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tafasitamab (MOR00208) + Lenalidomide (LEN)2Not reportedNot reportedNot reportedNot reported

Missing (No post baseline results available)

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tafasitamab (MOR00208) + Lenalidomide (LEN)7Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      title
      Yes (Treatment-emergent ADAs)
    2. measurements
      1. group Id
        OG000
        value
        72
      title
      No (Negative baseline and post baseline results)
    3. measurements
      1. group Id
        OG000
        value
        2
      title
      Not evaluable (Positive baseline results)
    4. measurements
      1. group Id
        OG000
        value
        7
      title
      Missing (No post baseline results available)
denoms
  1. counts
    1. group Id
      OG000
      value
      81
    units
    Participants
description
The Anti-MOR00208 Antibodies were investigated by quantifying serum drug levels at baseline and after repeated intravenous (IV) administrations planned for up to 24 treatment cycles using sparse sampling. Anti-MOR00208 antibody sample (pre-dose only) were taken in odd numbered additional treatment cycles only (e.g., treatment Cycles 13, 15,17, 19, 21,23).
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
COUNT_OF_PARTICIPANTS
population Description
Immunogenicity analysis set (IAS): The IAS included participants who had at least one anti-MOR00208 antibody assessment.
reporting Status
POSTED
time Frame
Baseline, Up to a maximum of 23 cycles.
title
Number of Participants Who Developed Anti-MOR00208 Antibodies
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice