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

October 12, 2021 updated by: MorphoSys AG

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3573

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Adelaide, Australia, 5000
        • MorphoSys Research Site
      • Benowa, Australia, 4217
        • MorphoSys Research Site
      • Concord, Australia, 2139
        • MorphoSys Research Site
      • Darlinghurst, Australia, 2010
        • MorphoSys Research Site
      • East Melbourne, Australia, 3002
        • MorphoSys Research Site
      • Fitzroy, Australia, 3065
        • MorphoSys Research Site
      • Frankston, Australia, 3099
        • MorphoSys Research Site
      • Kingswood, Australia, 2747
        • MorphoSys Research Site
      • Nedlands, Australia, 6009
        • MorphoSys Research Site
  • Austria
      • Leoben, Austria, 8700
        • MorphoSys Research Site
      • Linz, Austria, 4021
        • MorphoSys Research Site
      • Salzburg, Austria, 5020
        • MorphoSys Research Site
      • Sankt Pölten, Austria, 3100
        • MorphoSys Research Site
      • Wels, Austria, 4600
        • MorphoSys Research Site
      • Wien, Austria, 1090
        • MorphoSys Research Site
  • Canada
      • Edmonton, Canada, T6G
        • MorphoSys Research Site
      • Montréal, Canada, H1T
        • MorphoSys Research Site
  • Denmark
      • Aalborg, Denmark, 9100
        • MorphoSys Research Site
  • France
      • Albi, France, 81000
        • MorphoSys Research Site
      • Amiens, France, 80054
        • MorphoSys Research Site
      • Angers, France, 49100
        • MorphoSys Research Site
      • Caen, France, 14000
        • MorphoSys Research Site
      • Carcassonne, France, 11010
        • MorphoSys Research Site
      • Castres, France, 81108
        • MorphoSys Research Site
      • Chambéry, France, 73000
        • MorphoSys Research Site
      • Grenoble, France, 38043
        • MorphoSys Research Site
      • La Roche-sur-Yon, France, 85925
        • MorphoSys Research Site
      • Lille, France, 59020
        • MorphoSys Research Site
      • Montpellier, France, 34295
        • MorphoSys Research Site
      • Narbonne, France, 11100
        • MorphoSys Research Site
      • Nice, France, 06200
        • MorphoSys Research Site
      • Nîmes, France, 30029
        • MorphoSys Research Site
      • Orléans, France, 45100
        • MorphoSys Research Site
      • Paris, France, 75015
        • MorphoSys Research Site
      • Paris, France, 75013
        • MorphoSys Research Site
      • Perpignan, France, 66000
        • MorphoSys Research Site
      • Pessac, France, 33600
        • MorphoSys Research Site
      • Pierre-Bénite, France, 69495
        • MorphoSys Research Site
      • Quimper, France, 29107
        • MorphoSys Research Site
      • Rodez, France, 12027
        • MorphoSys Research Site
      • Rouen, France, 76031
        • MorphoSys Research Site
      • Saint-Brieuc, France, 22027
        • MorphoSys Research Site
      • Saint-Priest-en-Jarez, France, 42271
        • MorphoSys Research Site
      • Saint-Quentin, France, 02321
        • MorphoSys Research Site
      • Toulouse, France, 31100
        • MorphoSys Research Site
      • Tours, France, 37044
        • MorphoSys Research Site
      • Troyes, France, 10003
        • MorphoSys Research Site
      • Vandœuvre-lès-Nancy, France, 54500
        • MorphoSys Research Site
  • Germany
      • Aschaffenburg, Germany, 63739
        • MorphoSys Research Site
      • Augsburg, Germany, 86152
        • MorphoSys Research Site
      • Bad Liebenwerda, Germany, 04924
        • MorphoSys Research Site
      • Donauwörth, Germany, 86609
        • MorphoSys Research Site
      • Dresden, Germany, 01127
        • MorphoSys Research Site
      • Dresden, Germany, 01307
        • MorphoSys Research Site
      • Flensburg, Germany, 24939
        • MorphoSys Research Site
      • Frechen, Germany, 50226
        • MorphoSys Research Site
      • Freiburg im Breisgau, Germany, 79106
        • MorphoSys Research Site
      • Göttingen, Germany, 37073
        • MorphoSys Research Site
      • Halle, Germany, 06120
        • MorphoSys Research Site
      • Hamburg, Germany, 22081
        • MorphoSys Research Site
      • Hannover, Germany, 30161
        • MorphoSys Research Site
      • Hannover, Germany, 30171
        • MorphoSys Research Site
      • Heidelberg, Germany, 69115
        • MorphoSys Research Site
      • Heilbronn, Germany, 74078
        • MorphoSys Research Site
      • Köln, Germany, 51103
        • MorphoSys Research Site
      • Landshut, Germany, 84036
        • MorphoSys Research Site
      • Lebach, Germany, 66822
        • MorphoSys Research Site
      • Lübeck, Germany, 23538
        • MorphoSys Research Site
      • Mainz, Germany, 55131
        • MorphoSys Research Site
      • Münster, Germany, 48149
        • MorphoSys Research Site
      • Neustadt, Germany, 31535
        • MorphoSys Research Site
      • Oldenburg, Germany, 26121
        • MorphoSys Research Site
      • Oldenburg In Holstein, Germany, 23758
        • MorphoSys Research Site
      • Potsdam, Germany, 14467
        • MorphoSys Research Site
      • Ratingen, Germany, 40878
        • MorphoSys Research Site
      • Saarbrücken, Germany, 66113
        • MorphoSys Research Site
      • Schorndorf, Germany, 73614
        • MorphoSys Research Site
      • Stuttgart, Germany, 70376
        • MorphoSys Research Site
      • Villingen Schwenningen, Germany, 78052
        • MorphoSys Research Site
      • Villingen-Schwenningen, Germany, 78052
        • MorphoSys Research Site
      • Wilhelmshaven, Germany, 26389
        • MorphoSys Research Site
      • Wolfsburg, Germany, 38440
        • MorphoSys Research Site
  • Italy
      • Alessandria, Italy, 15100
        • MorphoSys Research Site
      • Ancona, Italy, 60126
        • MorphoSys Research Site
      • Aviano, Italy, 33081
        • MorphoSys Research Site
      • Bergamo, Italy, 24127
        • MorphoSys Research Site
      • Bologna, Italy, 40138
        • MorphoSys Research Site
      • Como, Italy, 22100
        • MorphoSys Research Site
      • Cremona, Italy, 26100
        • MorphoSys Research Site
      • Firenze, Italy, 50134
        • MorphoSys Research Site
      • Lecce, Italy, 73100
        • MorphoSys Research Site
      • Milano, Italy, 20132
        • MorphoSys Research Site
      • Modena, Italy, 41124
        • MorphoSys Research Site
      • Napoli, Italy, 80131
        • MorphoSys Research Site
      • Palermo, Italy, 90146
        • MorphoSys Research Site
      • Perugia, Italy, 06129
        • MorphoSys Research Site
      • Piacenza, Italy, 29121
        • MorphoSys Research Site
      • Ponderano, Italy, 13875
        • MorphoSys Research Site
      • Ravenna, Italy, 48121
        • MorphoSys Research Site
      • Reggio Calabria, Italy, 89124
        • MorphoSys Research Site
      • Rimini, Italy, 47923
        • MorphoSys Research Site
      • Roma, Italy, 00128
        • MorphoSys Research Site
      • Roma, Italy, 00161
        • MorphoSys Research Site
      • Roma, Italy, 00189
        • MorphoSys Research Site
      • Terni, Italy, 05100
        • MorphoSys Research Site
      • Udine, Italy, 33100
        • MorphoSys Research Site
      • Vicenza, Italy, 36100
        • MorphoSys Research Site
  • Korea, Republic of
      • Busan, Korea, Republic of, 49201
        • MorphoSys Research Site
      • Busan, Korea, Republic of, 49241
        • MorphoSys Research Site
      • Seoul, Korea, Republic of, 3080
        • MorphoSys Research Site
      • Seoul, Korea, Republic of, 5505
        • MorphoSys Research Site
      • Seoul, Korea, Republic of
        • MorphoSys Research Site
      • Ulsan, Korea, Republic of, 44033
        • MorphoSys Research Site
  • Spain
      • Badalona, Spain, 08916
        • MorphoSys Research Site
      • Barcelona, Spain, 08035
        • MorphoSys Research Site
      • Hospitalet de Llobregat, Spain, 08908
        • MorphoSys Research Site
      • Lugo, Spain, 27003
        • MorphoSys Research Site
      • Madrid, Spain, 28040
        • MorphoSys Research Site
      • Madrid, Spain, 28007
        • MorphoSys Research Site
      • Madrid, Spain, 28023
        • MorphoSys Research Site
      • Madrid, Spain, 28050
        • MorphoSys Research Site
      • Madrid, Spain, 28006
        • MorphoSys Research Site
      • Majadahonda, Spain, 28222
        • MorphoSys Research Site
      • Palma De Mallorca, Spain, 07120
        • MorphoSys Research Site
      • Palma De Mallorca, Spain, 07198
        • MorphoSys Research Site
      • Pamplona, Spain, 31008
        • MorphoSys Research Site
      • Pozuelo De Alarcón, Spain, 28223
        • MorphoSys Research Site
      • Sabadell, Spain, 08208
        • MorphoSys Research Site
      • Salamanca, Spain, 37007
        • MorphoSys Research Site
      • Santander, Spain, 39008
        • MorphoSys Research Site
      • Sevilla, Spain, 41013
        • MorphoSys Research Site
      • Valencia, Spain, 46015
        • MorphoSys Research Site
      • Valencia, Spain, 46026
        • MorphoSys Research Site
      • Valladolid, Spain, 47003
        • MorphoSys Research Site
      • Valladolid, Spain, 47012
        • MorphoSys Research Site
  • Taiwan
      • Taichung, Taiwan, 40705
        • MorphoSys Research Site
      • Tainan, Taiwan, 71004
        • MorphoSys Research Site
      • Taipei city, Taiwan, 100
        • MorphoSys Research Site
  • United Kingdom
      • Brighton, United Kingdom, BN2
        • MorphoSys Research Site
      • Manchester, United Kingdom, M20
        • MorphoSys Research Site
      • Sunderland, United Kingdom, SR4
        • MorphoSys Research Site
      • Taunton, United Kingdom, TA1
        • MorphoSys Research Site
      • Truro, United Kingdom, TR1
        • MorphoSys Research Site
      • Westcliff-on-Sea, United Kingdom, SS0
        • MorphoSys Research Site
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • MorphoSys Research Site
    • California
      • Clovis, California, United States, 93611
        • MorphoSys Research Site
      • Los Angeles, California, United States, 90015
        • MorphoSys Research Site
      • Orange, California, United States, 92868
        • MorphoSys Research Site
      • Torrance, California, United States, 90502
        • MorphoSys Research Site
    • Colorado
      • Broomfield, Colorado, United States, 80021
        • MorphoSys Research Site
    • Illinois
      • Chicago, Illinois, United States, 60637
        • MorphoSys Research Site
      • Skokie, Illinois, United States, 60077
        • MorphoSys Research Site
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • MorphoSys Research Site
    • Kansas
      • Wichita, Kansas, United States, 67214
        • MorphoSys Research Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • MorphoSys Research Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • MorphoSys Research Site
      • Rochester, Minnesota, United States, 55905
        • MorphoSys Research Site
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • MorphoSys Research Site
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • MorphoSys Research Site
    • New York
      • New York, New York, United States, 10029
        • MorphoSys Research Site
      • New York, New York, United States, 10075
        • MorphoSys Research Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • MorphoSys Research Site
    • Oregon
      • Portland, Oregon, United States, 97239
        • MorphoSys Research Site
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • MorphoSys Research Site
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • MorphoSys Research Site
    • Washington
      • Spokane, Washington, United States, 99218
        • MorphoSys Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with relapsed or refractory DLBCL

Description

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)
  5. Patients who received tafasitamab.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Patients who received systemic therapies for R/R DLBCL

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Overall/Objective Response Rate (ORR)
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Complete Response Rate (CR)
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Duration of Response (DoR)
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Event Free Survival (EFS)
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Progression Free Survival (PFS)
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Time to next treatment (TTNT)
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Treatment discontinuation rate due to adverse events
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Duration of treatment exposure
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
MorphoSys AG

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Eva Waltl, MorphoSys AG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 7, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 7, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 23, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 6, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 20, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 12, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MOR208C213

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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