Diffuse Large B Cell LymphomaRE-MIND2NCT04697160

Observational Retrospective Cohort Study of Systemic Therapies for R/R DLBCL

An observational study of Diffuse Large B Cell Lymphoma, run by MorphoSys AG at 165 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diffuse Large B Cell Lymphoma
How many people: 3,573 participants
Where: 165 sitesin 12 countries
Study dates: 1 Apr 2020to 7 May 2021
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients with relapsed or refractory DLBCL

Eligibility Criteria:

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

Patients with central nervous system (CNS) involvement by lymphoma at initial DLBCL diagnosis.
Patients who were treated with CD19-targeted therapy or immunomodulatory drugs (IMiDs) (e.g., thalidomide, LEN) as a frontline DLBCL therapy.
Patients who underwent an allogeneic stem cell transplant.
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:
basal cell carcinoma of the skin
squamous cell carcinoma of the skin
carcinoma in situ of the cervix
carcinoma in situ of the breast
carcinoma in situ of the bladder
incidental histological finding of prostate cancer (Tumor/Node/Metastasis [TNM] stage of T1a or T1b)
Patients who received tafasitamab.

Trial locations and contacts

165 sites in 12 countries.

Country

City, postcode or hospital

165 sites in 12 countries

Germany33 sites

MorphoSys Research Site
Aschaffenburg, 63739
MorphoSys Research Site
Augsburg, 86152
MorphoSys Research Site
Bad Liebenwerda, 04924
MorphoSys Research Site
Cologne, 51103
MorphoSys Research Site
Donauwörth, 86609
MorphoSys Research Site
Dresden, 01127
MorphoSys Research Site
Dresden, 01307
MorphoSys Research Site
Flensburg, 24939
MorphoSys Research Site
Frechen, 50226
MorphoSys Research Site
Freiburg im Breisgau, 79106
MorphoSys Research Site
Göttingen, 37073
MorphoSys Research Site
Halle, 06120
MorphoSys Research Site
Hamburg, 22081
MorphoSys Research Site
Hanover, 30161
MorphoSys Research Site
Hanover, 30171
MorphoSys Research Site
Heidelberg, 69115
MorphoSys Research Site
Heilbronn, 74078
MorphoSys Research Site
Landshut, 84036
MorphoSys Research Site
Lebach, 66822
MorphoSys Research Site
Lübeck, 23538
MorphoSys Research Site
Mainz, 55131
MorphoSys Research Site
Münster, 48149
MorphoSys Research Site
Neustadt, 31535
MorphoSys Research Site
Oldenburg, 26121
MorphoSys Research Site
Oldenburg in Holstein, 23758
MorphoSys Research Site
Potsdam, 14467
MorphoSys Research Site
Ratingen, 40878
MorphoSys Research Site
Saarbrücken, 66113
MorphoSys Research Site
Schorndorf, 73614
MorphoSys Research Site
Stuttgart, 70376
MorphoSys Research Site
Villingen-Schwenningen, 78052
MorphoSys Research Site
Wilhelmshaven, 26389
MorphoSys Research Site
Wolfsburg, 38440

Other trials in Germany

France30 sites

MorphoSys Research Site
Albi, 81000
MorphoSys Research Site
Amiens, 80054
MorphoSys Research Site
Angers, 49100
MorphoSys Research Site
Caen, 14000
MorphoSys Research Site
Carcassonne, 11010
MorphoSys Research Site
Castres, 81108
MorphoSys Research Site
Chambéry, 73000
MorphoSys Research Site
Grenoble, 38043
MorphoSys Research Site
La Roche-sur-Yon, 85925
MorphoSys Research Site
Lille, 59020
MorphoSys Research Site
Montpellier, 34295
MorphoSys Research Site
Narbonne, 11100
MorphoSys Research Site
Nice, 06200
MorphoSys Research Site
Nîmes, 30029
MorphoSys Research Site
Orléans, 45100
MorphoSys Research Site
Paris, 75013
MorphoSys Research Site
Paris, 75015
MorphoSys Research Site
Perpignan, 66000
MorphoSys Research Site
Pessac, 33600
MorphoSys Research Site
Pierre-Bénite, 69495
MorphoSys Research Site
Quimper, 29107
MorphoSys Research Site
Rodez, 12027
MorphoSys Research Site
Rouen, 76031
MorphoSys Research Site
Saint-Brieuc, 22027
MorphoSys Research Site
Saint-Priest-en-Jarez, 42271
MorphoSys Research Site
Saint-Quentin, 02321
MorphoSys Research Site
Toulouse, 31100
MorphoSys Research Site
Tours, 37044
MorphoSys Research Site
Troyes, 10003
MorphoSys Research Site
Vandœuvre-lès-Nancy, 54500

Other trials in France

Italy25 sites

MorphoSys Research Site
Alessandria, 15100
MorphoSys Research Site
Ancona, 60126
MorphoSys Research Site
Aviano, 33081
MorphoSys Research Site
Bergamo, 24127
MorphoSys Research Site
Bologna, 40138
MorphoSys Research Site
Como, 22100
MorphoSys Research Site
Cremona, 26100
MorphoSys Research Site
Florence, 50134
MorphoSys Research Site
Lecce, 73100
MorphoSys Research Site
Milan, 20132
MorphoSys Research Site
Modena, 41124
MorphoSys Research Site
Naples, 80131
MorphoSys Research Site
Palermo, 90146
MorphoSys Research Site
Perugia, 06129
MorphoSys Research Site
Piacenza, 29121
MorphoSys Research Site
Ponderano, 13875
MorphoSys Research Site
Ravenna, 48121
MorphoSys Research Site
Reggio Calabria, 89124
MorphoSys Research Site
Rimini, 47923
MorphoSys Research Site
Roma, 00128
MorphoSys Research Site
Roma, 00161
MorphoSys Research Site
Roma, 00189
MorphoSys Research Site
Terni, 05100
MorphoSys Research Site
Udine, 33100
MorphoSys Research Site
Vicenza, 36100

Other trials in Italy

United States22 sites

MorphoSys Research Site
Ann Arbor, Michigan, 48109
MorphoSys Research Site
Broomfield, Colorado, 80021
MorphoSys Research Site
Charlotte, North Carolina, 28204
MorphoSys Research Site
Chicago, Illinois, 60637
MorphoSys Research Site
Clovis, California, 93611
MorphoSys Research Site
Indianapolis, Indiana, 46260
MorphoSys Research Site
Jackson, Mississippi, 39216
MorphoSys Research Site
Los Angeles, California, 90015
MorphoSys Research Site
Minneapolis, Minnesota, 55455
MorphoSys Research Site
Morristown, New Jersey, 07960
MorphoSys Research Site
Nashville, Tennessee, 37232
MorphoSys Research Site
New York, New York, 10029
MorphoSys Research Site
New York, New York, 10075
MorphoSys Research Site
Orange, California, 92868
MorphoSys Research Site
Portland, Oregon, 97239
MorphoSys Research Site
Rochester, Minnesota, 55905
MorphoSys Research Site
Salt Lake City, Utah, 84112
MorphoSys Research Site
Scottsdale, Arizona, 85258
MorphoSys Research Site
Skokie, Illinois, 60077
MorphoSys Research Site
Spokane, Washington, 99218
MorphoSys Research Site
Torrance, California, 90502
MorphoSys Research Site
Wichita, Kansas, 67214

Other trials in United States

Spain22 sites

MorphoSys Research Site
Badalona, 08916
MorphoSys Research Site
Barcelona, 08035
MorphoSys Research Site
L'Hospitalet de Llobregat, 08908
MorphoSys Research Site
Lugo, 27003
MorphoSys Research Site
Madrid, 28006
MorphoSys Research Site
Madrid, 28007
MorphoSys Research Site
Madrid, 28023
MorphoSys Research Site
Madrid, 28040
MorphoSys Research Site
Madrid, 28050
MorphoSys Research Site
Majadahonda, 28222
MorphoSys Research Site
Palma de Mallorca, 07120
MorphoSys Research Site
Palma de Mallorca, 07198
MorphoSys Research Site
Pamplona, 31008
MorphoSys Research Site
Pozuelo de Alarcón, 28223
MorphoSys Research Site
Sabadell, 08208
MorphoSys Research Site
Salamanca, 37007
MorphoSys Research Site
Santander, 39008
MorphoSys Research Site
Seville, 41013
MorphoSys Research Site
Valencia, 46015
MorphoSys Research Site
Valencia, 46026
MorphoSys Research Site
Valladolid, 47003
MorphoSys Research Site
Valladolid, 47012

Other trials in Spain

Australia9 sites

MorphoSys Research Site
Adelaide, 5000
MorphoSys Research Site
Benowa, 4217
MorphoSys Research Site
Concord, 2139
MorphoSys Research Site
Darlinghurst, 2010
MorphoSys Research Site
East Melbourne, 3002
MorphoSys Research Site
Fitzroy, 3065
MorphoSys Research Site
Frankston, 3099
MorphoSys Research Site
Kingswood, 2747
MorphoSys Research Site
Nedlands, 6009

Other trials in Australia

Austria6 sites

MorphoSys Research Site
Leoben, 8700
MorphoSys Research Site
Linz, 4021
MorphoSys Research Site
Salzburg, 5020
MorphoSys Research Site
Sankt Pölten, 3100
MorphoSys Research Site
Vienna, 1090
MorphoSys Research Site
Wels, 4600

Other trials in Austria

South Korea6 sites

MorphoSys Research Site
Busan, 49201
MorphoSys Research Site
Busan, 49241
MorphoSys Research Site
Seoul, 3080
MorphoSys Research Site
Seoul, 5505
MorphoSys Research Site
Seoul
MorphoSys Research Site
Ulsan, 44033

Other trials in South Korea

United Kingdom6 sites

MorphoSys Research Site
Brighton, BN2
MorphoSys Research Site
Manchester, M20
MorphoSys Research Site
Sunderland, SR4
MorphoSys Research Site
Taunton, TA1
MorphoSys Research Site
Truro, TR1
MorphoSys Research Site
Westcliff-on-Sea, SS0

Other trials in United Kingdom

Taiwan3 sites

MorphoSys Research Site
Taichung, 40705
MorphoSys Research Site
Tainan, 71004
MorphoSys Research Site
Taipei, 100

Other trials in Taiwan

Canada2 sites

MorphoSys Research Site
Edmonton, T6G
MorphoSys Research Site
Montreal, H1T

Other trials in Canada

Denmark1 site

MorphoSys Research Site
Aalborg, 9100

Other trials in Denmark

About this study

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

Read the 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.

Conditions: Diffuse Large B Cell Lymphoma
Medical subject headings: Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04697160
Study group	Role	What they receive
Patients who received systemic therapies for R/R DLBCL		Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall Survival (OS)
Measured: through study completion, an average of 1 year

Secondary outcomes (8)

Overall/Objective Response Rate (ORR)
Measured: through study completion, an average of 1 year
Complete Response Rate (CR)
Measured: through study completion, an average of 1 year
Duration of Response (DoR)
Measured: through study completion, an average of 1 year
Event Free Survival (EFS)
Measured: through study completion, an average of 1 year
Progression Free Survival (PFS)
Measured: through study completion, an average of 1 year
Time to next treatment (TTNT)
Measured: through study completion, an average of 1 year
Treatment discontinuation rate due to adverse events
Measured: through study completion, an average of 1 year
Duration of treatment exposure
Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 20207 May 2021

First posted6 Jan 2021
Study start1 Apr 2020
Primary completion7 May 2021
Study completion7 May 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Diffuse Large B Cell LymphomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 3,573 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04697160
Sponsor's protocol ID: MOR208C213
Acronym: RE-MIND2
Status last verified: Oct 2021
First submitted: 23 Dec 2020
Last updated: 20 Oct 2021
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Nowakowski GS, Yoon DH, Mondello P, Joffe E, Peters A, Fleury I, Greil R, Ku M, Marks R, Kim K, Zinzani PL, Trotman J, Sabatelli L, Waltl EE, Winderlich M, Sporchia A, Kurukulasuriya NC, Cordoba R, Hess G, Salles G. RE-MIND2: comparative effectiveness of tafasitamab plus lenalidomide versus polatuzumab vedotin/bendamustine/rituximab (pola-BR), CAR-T therapies, and lenalidomide/rituximab (R2) based on real-world data in patients with relapsed/refractory diffuse large B-cell lymphoma. Ann Hematol. 2023 Jul;102(7):1773-1787. doi: 10.1007/s00277-023-05196-4. Epub 2023 May 12.
PubMed 37171597
Nowakowski GS, Yoon DH, Peters A, Mondello P, Joffe E, Fleury I, Greil R, Ku M, Marks R, Kim K, Zinzani PL, Trotman J, Huang D, Waltl EE, Winderlich M, Kurukulasuriya NC, Ambarkhane S, Hess G, Salles G. Improved Efficacy of Tafasitamab plus Lenalidomide versus Systemic Therapies for Relapsed/Refractory DLBCL: RE-MIND2, an Observational Retrospective Matched Cohort Study. Clin Cancer Res. 2022 Sep 15;28(18):4003-4017. doi: 10.1158/1078-0432.CCR-21-3648.
PubMed 35674661

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diffuse Large B Cell Lymphoma trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04697160
Acronym / sponsor ID: RE-MIND2 / MOR208C213
Conditions: Diffuse Large B Cell Lymphoma
Study type: Observational
Recruitment status: Completed
Enrolment: 3,573 participants (actual)
Lead sponsor: MorphoSys AGIndustry (pharma, biotech, devices)
Study start: 1 Apr 2020 (actual)
Primary completion: 7 May 2021 (actual)
Study completion: 7 May 2021 (actual)
First posted: 6 Jan 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
Patients who received systemic therapies for R/R DLBCL	–	–

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with relapsed or refractory DLBCL

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Overall Survival (OS)
Time frame: through study completion, an average of 1 year

8 secondary outcomes

Overall/Objective Response Rate (ORR)
Time frame: through study completion, an average of 1 year
Complete Response Rate (CR)
Time frame: through study completion, an average of 1 year
Duration of Response (DoR)
Time frame: through study completion, an average of 1 year
Event Free Survival (EFS)
Time frame: through study completion, an average of 1 year
Progression Free Survival (PFS)
Time frame: through study completion, an average of 1 year
Time to next treatment (TTNT)
Time frame: 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
Duration of treatment exposure
Time frame: through study completion, an average of 1 year

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2021.
Derived from this study: PubMed 37171597Nowakowski GS, Yoon DH, Mondello P, Joffe E, Peters A, Fleury I, Greil R, Ku M, Marks R, Kim K, Zinzani PL, Trotman J, Sabatelli L, Waltl EE, Winderlich M, Sporchia A, Kurukulasuriya NC, Cordoba R, Hess G, Salles G. RE-MIND2: comparative effectiveness of tafasitamab plus lenalidomide versus polatuzumab vedotin/bendamustine/rituximab (pola-BR), CAR-T therapies, and lenalidomide/rituximab (R2) based on real-world data in patients with relapsed/refractory diffuse large B-cell lymphoma. Ann Hematol. 2023 Jul;102(7):1773-1787. doi: 10.1007/s00277-023-05196-4. Epub 2023 May 12.
Derived from this study: PubMed 35674661Nowakowski GS, Yoon DH, Peters A, Mondello P, Joffe E, Fleury I, Greil R, Ku M, Marks R, Kim K, Zinzani PL, Trotman J, Huang D, Waltl EE, Winderlich M, Kurukulasuriya NC, Ambarkhane S, Hess G, Salles G. Improved Efficacy of Tafasitamab plus Lenalidomide versus Systemic Therapies for Relapsed/Refractory DLBCL: RE-MIND2, an Observational Retrospective Matched Cohort Study. Clin Cancer Res. 2022 Sep 15;28(18):4003-4017. doi: 10.1158/1078-0432.CCR-21-3648.

Related trials for Diffuse Large B Cell Lymphoma

Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
Not yet recruitingPhase 2
The CARDIOPROTECT Trial
Diffuse Large B-cell Lymphoma (DLBCL), Cardiotoxicity
Not yet recruitingPhase 2
QLS4131 Plus Isa-V-CHOP in Newly Diagnosed, HIV-Negative PBL: A Single-Center, Single-Arm, Phase II Study
Plasmablastic Lymphoma
RecruitingPhase 2
Testing the Effectiveness of a Combination Targeted Therapy (ViPOR) for Patients With Relapsed and/or Refractory Aggressive B-cell Lymphoma
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Eva Waltl study director

MorphoSys AG

165 sites in 12 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Diffuse Large B Cell Lymphoma, run by MorphoSys AG at 165 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 165 sites in Germany, France, Italy, United States, Spain and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04697160, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2021.