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RE-MIND: Lenalidomide Monotherapy in R/R DLBCL

Sponsor
MorphoSys AG (Industry)
Overall Status
Completed
CT.gov ID
NCT04150328
Collaborator
(none)
490
Enrollment
57
Locations
16.5
Actual Duration (Months)
8.6
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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)

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    490 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    An Observational Retrospective Cohort Study of Lenalidomide Monotherapy in Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL) to Generate a Historical Control for Clinical Trial MOR208C203 (RE-MIND)
    Actual Study Start Date :
    Apr 12, 2019
    Actual Primary Completion Date :
    Aug 25, 2019
    Actual Study Completion Date :
    Aug 25, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Best overall/objective response rate (ORR) [Through study completion, an average of 9 months]

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

    Secondary Outcome Measures

    1. Overall survival [Through study completion, an average of 9 months]

      Time from treatment start until death from any cause

    2. Complete response rate [Through study completion, an average of 9 months]

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

    3. Disease control rate [Through study completion, an average of 9 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 MorphoSys Research Site Rochester Minnesota United States 55905
    2 MorphoSys Research Site Saint Louis Missouri United States 63110
    3 MorphoSys Research Site Manhasset New York United States 11030
    4 MorphoSys Research Site New York New York United States 10013
    5 MorphoSys Research Site Rochester New York United States 14642
    6 MorphoSys Research Site Dublin Ohio United States 43017
    7 MorphoSys Research Site Charleston South Carolina United States 29425
    8 MorphoSys Research Site Greenville South Carolina United States 29615
    9 MorphoSys Research Site Bordeaux France 76038
    10 MorphoSys Research Site Le Mans France 72037
    11 MorphoSys Research Site Lille France 59037
    12 MorphoSys Research Site Lyon France 69495
    13 MorphoSys Research Site Paris France 75010
    14 MorphoSys Research Site Paris France 75743
    15 MorphoSys Research Site Poitiers France 86000
    16 MorphoSys Research Site Pontoise France 95300
    17 MorphoSys Research Site Rouen France 76038
    18 MorphoSys Research Site Toulouse France 31059
    19 MorphoSys Research Site Tours France 37044
    20 MorphoSys Research Site Aviano Italy 33081
    21 MorphoSys Research Site Bergamo Italy 24127
    22 MorphoSys Research Site Bologna Italy 40138
    23 MorphoSys Research Site Brescia Italy 25123
    24 MorphoSys Research Site Como Italy 22100
    25 MorphoSys Research Site Cuneo Italy 12100
    26 MorphoSys Research Site Firenze Italy 50134
    27 MorphoSys Research Site Meldola Italy 47014
    28 MorphoSys Research Site Milano Italy 20132
    29 MorphoSys Research Site Milano Italy 20141
    30 MorphoSys Research Site Milano Italy 20162
    31 MorphoSys Research Site Modena Italy 41124
    32 MorphoSys Research Site Napoli Italy 80131_2
    33 MorphoSys Research Site Napoli Italy 80131
    34 MorphoSys Research State Novara Italy 28100
    35 MorphoSys Research Site Padova Italy 35128
    36 MorphoSys Research Site Parma Italy 43126
    37 MorphoSys Research Site Pavia Italy 27100
    38 MorphoSys Research Site Perugia Italy 06129
    39 MorphoSys Research Site Piacenza Italy 29121
    40 MorphoSys Research Site Ponderano Italy 13875
    41 MorphoSys Research Site Ravenna Italy 48121
    42 MorphoSys Research Site Reggio Emilia Italy 42132
    43 MorphoSys Research Site Rimini Italy 47923
    44 MorphoSys Research Site Roma Italy 00128
    45 MorphoSys Research Site Roma Italy 00161
    46 MorphoSys Research Site Roma Italy 00189
    47 MorphoSys Research Site Salerno Italy 84131
    48 MorphoSys Research Site San Giovanni Rotondo Italy 71013
    49 MorphoSys Research Site Torino Italy 10126_2
    50 MorphoSys Research Site Torino Italy 10126
    51 MorphoSys Research Site Torino Italy 10128
    52 MorphoSys Research Site Udine Italy 33100
    53 MorphoSys Research Site Verona Italy 37100
    54 MorphoSys Research Site Vicenza Italy 36100
    55 MorphoSys Research Site Barcelona Spain 08003
    56 MorphoSys Research Site Madrid Spain 28041
    57 MorphoSys Research Site Salamanca Spain 37007

    Sponsors and Collaborators

    • MorphoSys AG

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    MorphoSys AG
    ClinicalTrials.gov Identifier:
    NCT04150328
    Other Study ID Numbers:
    • MOR208C206
    First Posted:
    Nov 4, 2019
    Last Update Posted:
    Aug 24, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, B-Cell
    Lymphoma, Large B-Cell, Diffuse

    Study Results

    No Results Posted as of Aug 24, 2022