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CompletedNCT04150328RE-MINDUpdated Aug 24, 2022

Lenalidomide Monotherapy in R/R DLBCL

An observational study in Diffuse Large B Cell Lymphoma, sponsored by MorphoSys AG. Completed at 57 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-24.

Sponsored by MorphoSys AG · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
490
Ages
18 Years and older
Sex
All
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Study summary

This observational study is designed to characterise the effectiveness of lenalidomide monotherapy in the treatment of R/R DLBCL and to compare the results with the efficacy outcomes of a tafasitamab-lenalidomide combination therapy in the clinical trial MOR208C203 (L-MIND)

Read the detailed description

Tafasitamab (MOR00208) is currently in development for the treatment of R/R DLBCL. An ongoing, single-arm, phase II, open label, multicenter study (MOR208C203) is evaluating the efficacy and safety of tafasitamab combined with lenalidomide in patients with R/R DLBCL. In order to establish a lenalidomide monotherapy as a control cohort, this observational study aims to collect retrospective lenalidomide monotherapy data from real-world-evidence and to compare it with the tafasitamab-lenalidomide combination therapy.

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Conditions studied

03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 490 is above the median of 136 across 625 observational studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

MorphoSys AG is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

R/R DLBCL patients not eligible for HDC followed by ASCT who were treated with lenalidomide monotherapy

Inclusion criteria

  • Histologically confirmed diagnosis of DLBCL
  • Relapsed/refractory to at least one previous systemic therapy for DLBCL
  • Received at least one, but no more than three previous systemic regimens for the treatment of DLBCL, including at least one anti-CD20 containing therapy
  • Received lenalidomide monotherapy for R/R DLBCL while being considered not eligible for an ASCT

Exclusion criteria

Exclusion Criteria:

  • CNS involvement by lymphoma
  • Patients who received lenalidomide in combination with another anti-lymphoma therapy (including radiation)
  • Previously treated with anti-CD19-targeted therapy or immunomodulatory drugs
  • Patients who previously underwent allogeneic SCT
  • Known simultaneous detection of MYC and BCL2 or BCL6 translocation according to FISH
  • Patients with a history of other malignancies within 5 years prior to lenalidomide treatment start
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
490 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Best overall/objective response rate (ORR)

    Proportion of patients with complete response (CR) or partial response (PR) as best response achieved at any time during the study

    Time frame: Through study completion, an average of 9 months

Secondary outcomes

  1. Overall survival

    Time from treatment start until death from any cause

    Time frame: Through study completion, an average of 9 months

  2. Complete response rate

    Proportion of patients having CR based on the best objective response achieved at any time during the study

    Time frame: Through study completion, an average of 9 months

  3. Disease control rate

    Proportion of patients having CR, PR or stable disease (SD) based on the best objective response achieved at any time during the study

    Time frame: Through study completion, an average of 9 months

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Study locations

57 sites
  • MorphoSys Research Site
    Rochester, Minnesota 55905, United States
  • MorphoSys Research Site
    Saint Louis, Missouri 63110, United States
  • MorphoSys Research Site
    Manhasset, New York 11030, United States
  • MorphoSys Research Site
    New York, New York 10013, United States
  • MorphoSys Research Site
    Rochester, New York 14642, United States
  • MorphoSys Research Site
    Dublin, Ohio 43017, United States
  • MorphoSys Research Site
    Charleston, South Carolina 29425, United States
  • MorphoSys Research Site
    Greenville, South Carolina 29615, United States
  • MorphoSys Research Site
    Bordeaux, 76038, France
  • MorphoSys Research Site
    Le Mans, 72037, France
  • MorphoSys Research Site
    Lille, 59037, France
  • MorphoSys Research Site
    Lyon, 69495, France
  • MorphoSys Research Site
    Paris, 75010, France
  • MorphoSys Research Site
    Paris, 75743, France
  • MorphoSys Research Site
    Poitiers, 86000, France
  • MorphoSys Research Site
    Pontoise, 95300, France
  • MorphoSys Research Site
    Rouen, 76038, France
  • MorphoSys Research Site
    Toulouse, 31059, France
  • MorphoSys Research Site
    Tours, 37044, France
  • MorphoSys Research Site
    Aviano, 33081, Italy
  • MorphoSys Research Site
    Bergamo, 24127, Italy
  • MorphoSys Research Site
    Bologna, 40138, Italy
  • MorphoSys Research Site
    Brescia, 25123, Italy
  • MorphoSys Research Site
    Como, 22100, Italy
  • MorphoSys Research Site
    Cuneo, 12100, Italy
  • MorphoSys Research Site
    Firenze, 50134, Italy
  • MorphoSys Research Site
    Meldola, 47014, Italy
  • MorphoSys Research Site
    Milano, 20132, Italy
  • MorphoSys Research Site
    Milano, 20141, Italy
  • MorphoSys Research Site
    Milano, 20162, Italy
  • MorphoSys Research Site
    Modena, 41124, Italy
  • MorphoSys Research Site
    Napoli, 80131_2, Italy
  • MorphoSys Research Site
    Napoli, 80131, Italy
  • MorphoSys Research State
    Novara, 28100, Italy
  • MorphoSys Research Site
    Padova, 35128, Italy
  • MorphoSys Research Site
    Parma, 43126, Italy
  • MorphoSys Research Site
    Pavia, 27100, Italy
  • MorphoSys Research Site
    Perugia, 06129, Italy
  • MorphoSys Research Site
    Piacenza, 29121, Italy
  • MorphoSys Research Site
    Ponderano, 13875, Italy
  • MorphoSys Research Site
    Ravenna, 48121, Italy
  • MorphoSys Research Site
    Reggio Emilia, 42132, Italy
  • MorphoSys Research Site
    Rimini, 47923, Italy
  • MorphoSys Research Site
    Roma, 00128, Italy
  • MorphoSys Research Site
    Roma, 00161, Italy
  • MorphoSys Research Site
    Roma, 00189, Italy
  • MorphoSys Research Site
    Salerno, 84131, Italy
  • MorphoSys Research Site
    San Giovanni Rotondo, 71013, Italy
  • MorphoSys Research Site
    Torino, 10126_2, Italy
  • MorphoSys Research Site
    Torino, 10126, Italy
  • MorphoSys Research Site
    Torino, 10128, Italy
  • MorphoSys Research Site
    Udine, 33100, Italy
  • MorphoSys Research Site
    Verona, 37100, Italy
  • MorphoSys Research Site
    Vicenza, 36100, Italy
  • MorphoSys Research Site
    Barcelona, 08003, Spain
  • MorphoSys Research Site
    Madrid, 28041, Spain
  • MorphoSys Research Site
    Salamanca, 37007, Spain
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 24, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04150328
Lead sponsor
MorphoSys AG
Responsible party
Sponsor
First posted
Nov 4, 2019
Start date
Apr 12, 2019
Primary completion
Aug 25, 2019
Completion
Aug 25, 2020
Last update
Aug 24, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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