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RE-MIND2: Observational Retrospective Cohort Study of Systemic Therapies for R/R DLBCL

Sponsor
MorphoSys AG (Industry)
Overall Status
Completed
CT.gov ID
NCT04697160
Collaborator
(none)
3,573
Enrollment
166
Locations
13.2
Actual Duration (Months)
21.5
Patients Per Site
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To compare the efficacy outcomes of the L-MIND cohort with the effectiveness in a matched patient population treated with systemic NCCN/ESMO guideline listed regimens administered in routine clinical care.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This retrospective observational cohort study aims to generate a historical control consisting of R/R DLBCL patients who received currently guideline recommended therapies.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    3573 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    An Observational Retrospective Cohort Study of Systemic Therapies for Relapsed or Refractory Diffuse Large B Cell Lymphoma (R/R DLBCL), to Compare Outcomes to Those From Tafasitamab + Lenalidomide in the L-MIND Study
    Actual Study Start Date :
    Apr 1, 2020
    Actual Primary Completion Date :
    May 7, 2021
    Actual Study Completion Date :
    May 7, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    Patients who received systemic therapies for R/R DLBCL

    Outcome Measures

    Primary Outcome Measures

    1. Overall Survival (OS) [through study completion, an average of 1 year]

    Secondary Outcome Measures

    1. Overall/Objective Response Rate (ORR) [through study completion, an average of 1 year]

    2. Complete Response Rate (CR) [through study completion, an average of 1 year]

    3. Duration of Response (DoR) [through study completion, an average of 1 year]

    4. Event Free Survival (EFS) [through study completion, an average of 1 year]

    5. Progression Free Survival (PFS) [through study completion, an average of 1 year]

    6. Time to next treatment (TTNT) [through study completion, an average of 1 year]

    7. Treatment discontinuation rate due to adverse events [through study completion, an average of 1 year]

    8. Duration of treatment exposure [through study completion, an average of 1 year]

    Eligibility Criteria

    Criteria

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

    1. Age ≥ 18 years at the initial DLBCL diagnosis.

    2. One of the following histologically confirmed diagnosis: DLBCL not otherwise specified (NOS); T-cell/histiocyte rich large B-cell lymphoma (THRLBCL); Epstein-Barr virus (EBV) positive DLBCL of the elderly (EBV-positive DLBCL), Grade 3b Follicular Lymphoma (FL), Composite lymphoma with a DLBCL component with a subsequent DLBCL relapse, according to the Revised European American Lymphoma/World Health Organization (REAL/WHO) classification. Additionally, patients with the evidence of histological transformation to DLBCL from an earlier diagnosis of low grade lymphoma (i.e., an indolent pathology such as FL, marginal zone lymphoma, chronic lymphocytic leukemia) into DLBCL with a subsequent DLBCL relapse are also eligible.

    3. Relapsed or refractory DLBCL and received at least 2 systemic regimens for the treatment of DLBCL, including at least 1 anti-CD20 containing therapy.

    Non-Eligibility Criteria:

    1. Patients with central nervous system (CNS) involvement by lymphoma at initial DLBCL diagnosis.

    2. Patients who were treated with CD19-targeted therapy or immunomodulatory drugs (IMiDs) (e.g., thalidomide, LEN) as a frontline DLBCL therapy.

    3. Patients who underwent an allogeneic stem cell transplant.

    4. Patients who had a prior history of malignancies other than DLBCL, unless the patient has been free of the disease for ≥5 years prior to inclusion.

    Note: Patients with the following malignancies within the 5 years period are still eligible:

    1. basal cell carcinoma of the skin

    2. squamous cell carcinoma of the skin

    3. carcinoma in situ of the cervix

    4. carcinoma in situ of the breast

    5. carcinoma in situ of the bladder

    6. incidental histological finding of prostate cancer (Tumor/Node/Metastasis [TNM] stage of T1a or T1b)

    7. Patients who received tafasitamab.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 MorphoSys Research Site Scottsdale Arizona United States 85258
    2 MorphoSys Research Site Clovis California United States 93611
    3 MorphoSys Research Site Los Angeles California United States 90015
    4 MorphoSys Research Site Orange California United States 92868
    5 MorphoSys Research Site Torrance California United States 90502
    6 MorphoSys Research Site Broomfield Colorado United States 80021
    7 MorphoSys Research Site Chicago Illinois United States 60637
    8 MorphoSys Research Site Skokie Illinois United States 60077
    9 MorphoSys Research Site Indianapolis Indiana United States 46260
    10 MorphoSys Research Site Wichita Kansas United States 67214
    11 MorphoSys Research Site Ann Arbor Michigan United States 48109
    12 MorphoSys Research Site Minneapolis Minnesota United States 55455
    13 MorphoSys Research Site Rochester Minnesota United States 55905
    14 MorphoSys Research Site Jackson Mississippi United States 39216
    15 MorphoSys Research Site Morristown New Jersey United States 07960
    16 MorphoSys Research Site New York New York United States 10029
    17 MorphoSys Research Site New York New York United States 10075
    18 MorphoSys Research Site Charlotte North Carolina United States 28204
    19 MorphoSys Research Site Portland Oregon United States 97239
    20 MorphoSys Research Site Nashville Tennessee United States 37232
    21 MorphoSys Research Site Salt Lake City Utah United States 84112
    22 MorphoSys Research Site Spokane Washington United States 99218
    23 MorphoSys Research Site Adelaide Australia 5000
    24 MorphoSys Research Site Benowa Australia 4217
    25 MorphoSys Research Site Concord Australia 2139
    26 MorphoSys Research Site Darlinghurst Australia 2010
    27 MorphoSys Research Site East Melbourne Australia 3002
    28 MorphoSys Research Site Fitzroy Australia 3065
    29 MorphoSys Research Site Frankston Australia 3099
    30 MorphoSys Research Site Kingswood Australia 2747
    31 MorphoSys Research Site Nedlands Australia 6009
    32 MorphoSys Research Site Leoben Austria 8700
    33 MorphoSys Research Site Linz Austria 4021
    34 MorphoSys Research Site Salzburg Austria 5020
    35 MorphoSys Research Site Sankt Pölten Austria 3100
    36 MorphoSys Research Site Wels Austria 4600
    37 MorphoSys Research Site Wien Austria 1090
    38 MorphoSys Research Site Edmonton Canada T6G
    39 MorphoSys Research Site Montréal Canada H1T
    40 MorphoSys Research Site Aalborg Denmark 9100
    41 MorphoSys Research Site Albi France 81000
    42 MorphoSys Research Site Amiens France 80054
    43 MorphoSys Research Site Angers France 49100
    44 MorphoSys Research Site Caen France 14000
    45 MorphoSys Research Site Carcassonne France 11010
    46 MorphoSys Research Site Castres France 81108
    47 MorphoSys Research Site Chambéry France 73000
    48 MorphoSys Research Site Grenoble France 38043
    49 MorphoSys Research Site La Roche-sur-Yon France 85925
    50 MorphoSys Research Site Lille France 59020
    51 MorphoSys Research Site Montpellier France 34295
    52 MorphoSys Research Site Narbonne France 11100
    53 MorphoSys Research Site Nice France 06200
    54 MorphoSys Research Site Nîmes France 30029
    55 MorphoSys Research Site Orléans France 45100
    56 MorphoSys Research Site Paris France 75013
    57 MorphoSys Research Site Paris France 75015
    58 MorphoSys Research Site Perpignan France 66000
    59 MorphoSys Research Site Pessac France 33600
    60 MorphoSys Research Site Pierre-Bénite France 69495
    61 MorphoSys Research Site Quimper France 29107
    62 MorphoSys Research Site Rodez France 12027
    63 MorphoSys Research Site Rouen France 76031
    64 MorphoSys Research Site Saint-Brieuc France 22027
    65 MorphoSys Research Site Saint-Priest-en-Jarez France 42271
    66 MorphoSys Research Site Saint-Quentin France 02321
    67 MorphoSys Research Site Toulouse France 31100
    68 MorphoSys Research Site Tours France 37044
    69 MorphoSys Research Site Troyes France 10003
    70 MorphoSys Research Site Vandœuvre-lès-Nancy France 54500
    71 MorphoSys Research Site Aschaffenburg Germany 63739
    72 MorphoSys Research Site Augsburg Germany 86152
    73 MorphoSys Research Site Bad Liebenwerda Germany 04924
    74 MorphoSys Research Site Donauwörth Germany 86609
    75 MorphoSys Research Site Dresden Germany 01127
    76 MorphoSys Research Site Dresden Germany 01307
    77 MorphoSys Research Site Flensburg Germany 24939
    78 MorphoSys Research Site Frechen Germany 50226
    79 MorphoSys Research Site Freiburg im Breisgau Germany 79106
    80 MorphoSys Research Site Göttingen Germany 37073
    81 MorphoSys Research Site Halle Germany 06120
    82 MorphoSys Research Site Hamburg Germany 22081
    83 MorphoSys Research Site Hannover Germany 30161
    84 MorphoSys Research Site Hannover Germany 30171
    85 MorphoSys Research Site Heidelberg Germany 69115
    86 MorphoSys Research Site Heilbronn Germany 74078
    87 MorphoSys Research Site Köln Germany 51103
    88 MorphoSys Research Site Landshut Germany 84036
    89 MorphoSys Research Site Lebach Germany 66822
    90 MorphoSys Research Site Lübeck Germany 23538
    91 MorphoSys Research Site Mainz Germany 55131
    92 MorphoSys Research Site Münster Germany 48149
    93 MorphoSys Research Site Neustadt Germany 31535
    94 MorphoSys Research Site Oldenburg In Holstein Germany 23758
    95 MorphoSys Research Site Oldenburg Germany 26121
    96 MorphoSys Research Site Potsdam Germany 14467
    97 MorphoSys Research Site Ratingen Germany 40878
    98 MorphoSys Research Site Saarbrücken Germany 66113
    99 MorphoSys Research Site Schorndorf Germany 73614
    100 MorphoSys Research Site Stuttgart Germany 70376
    101 MorphoSys Research Site Villingen Schwenningen Germany 78052
    102 MorphoSys Research Site Villingen-Schwenningen Germany 78052
    103 MorphoSys Research Site Wilhelmshaven Germany 26389
    104 MorphoSys Research Site Wolfsburg Germany 38440
    105 MorphoSys Research Site Alessandria Italy 15100
    106 MorphoSys Research Site Ancona Italy 60126
    107 MorphoSys Research Site Aviano Italy 33081
    108 MorphoSys Research Site Bergamo Italy 24127
    109 MorphoSys Research Site Bologna Italy 40138
    110 MorphoSys Research Site Como Italy 22100
    111 MorphoSys Research Site Cremona Italy 26100
    112 MorphoSys Research Site Firenze Italy 50134
    113 MorphoSys Research Site Lecce Italy 73100
    114 MorphoSys Research Site Milano Italy 20132
    115 MorphoSys Research Site Modena Italy 41124
    116 MorphoSys Research Site Napoli Italy 80131
    117 MorphoSys Research Site Palermo Italy 90146
    118 MorphoSys Research Site Perugia Italy 06129
    119 MorphoSys Research Site Piacenza Italy 29121
    120 MorphoSys Research Site Ponderano Italy 13875
    121 MorphoSys Research Site Ravenna Italy 48121
    122 MorphoSys Research Site Reggio Calabria Italy 89124
    123 MorphoSys Research Site Rimini Italy 47923
    124 MorphoSys Research Site Roma Italy 00128
    125 MorphoSys Research Site Roma Italy 00161
    126 MorphoSys Research Site Roma Italy 00189
    127 MorphoSys Research Site Terni Italy 05100
    128 MorphoSys Research Site Udine Italy 33100
    129 MorphoSys Research Site Vicenza Italy 36100
    130 MorphoSys Research Site Busan Korea, Republic of 49201
    131 MorphoSys Research Site Busan Korea, Republic of 49241
    132 MorphoSys Research Site Seoul Korea, Republic of 3080
    133 MorphoSys Research Site Seoul Korea, Republic of 5505
    134 MorphoSys Research Site Seoul Korea, Republic of
    135 MorphoSys Research Site Ulsan Korea, Republic of 44033
    136 MorphoSys Research Site Badalona Spain 08916
    137 MorphoSys Research Site Barcelona Spain 08035
    138 MorphoSys Research Site Hospitalet de Llobregat Spain 08908
    139 MorphoSys Research Site Lugo Spain 27003
    140 MorphoSys Research Site Madrid Spain 28006
    141 MorphoSys Research Site Madrid Spain 28007
    142 MorphoSys Research Site Madrid Spain 28023
    143 MorphoSys Research Site Madrid Spain 28040
    144 MorphoSys Research Site Madrid Spain 28050
    145 MorphoSys Research Site Majadahonda Spain 28222
    146 MorphoSys Research Site Palma De Mallorca Spain 07120
    147 MorphoSys Research Site Palma De Mallorca Spain 07198
    148 MorphoSys Research Site Pamplona Spain 31008
    149 MorphoSys Research Site Pozuelo De Alarcón Spain 28223
    150 MorphoSys Research Site Sabadell Spain 08208
    151 MorphoSys Research Site Salamanca Spain 37007
    152 MorphoSys Research Site Santander Spain 39008
    153 MorphoSys Research Site Sevilla Spain 41013
    154 MorphoSys Research Site Valencia Spain 46015
    155 MorphoSys Research Site Valencia Spain 46026
    156 MorphoSys Research Site Valladolid Spain 47003
    157 MorphoSys Research Site Valladolid Spain 47012
    158 MorphoSys Research Site Taichung Taiwan 40705
    159 MorphoSys Research Site Tainan Taiwan 71004
    160 MorphoSys Research Site Taipei city Taiwan 100
    161 MorphoSys Research Site Brighton United Kingdom BN2
    162 MorphoSys Research Site Manchester United Kingdom M20
    163 MorphoSys Research Site Sunderland United Kingdom SR4
    164 MorphoSys Research Site Taunton United Kingdom TA1
    165 MorphoSys Research Site Truro United Kingdom TR1
    166 MorphoSys Research Site Westcliff-on-Sea United Kingdom SS0

    Sponsors and Collaborators

    • MorphoSys AG

    Investigators

    • Study Director: Eva Waltl, MorphoSys AG

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    MorphoSys AG
    ClinicalTrials.gov Identifier:
    NCT04697160
    Other Study ID Numbers:
    • MOR208C213
    First Posted:
    Jan 6, 2021
    Last Update Posted:
    Oct 20, 2021
    Last Verified:
    Oct 1, 2021
    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 Oct 20, 2021