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

NCT04697160 | Completed

• 1 other identifier: MOR208C213
• Study Type: observational
• Target: 3,573
• Locations: 11 countries
• Sites: 156

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.

Conditions

Diffuse Large B Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  through study completion, an average of 1 year

Secondary Outcomes (8)

• Overall/Objective Response Rate (ORR)

  through study completion, an average of 1 year

• Complete Response Rate (CR)

  through study completion, an average of 1 year

• Duration of Response (DoR)

  through study completion, an average of 1 year

• Event Free Survival (EFS)

  through study completion, an average of 1 year

• Progression Free Survival (PFS)

  through study completion, an average of 1 year

Study Arms (1)

Patients who received systemic therapies for R/R DLBCL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with relapsed or refractory DLBCL

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• MorphoSys AG: lead

Study Sites (165)

MorphoSys Research Site

Scottsdale, Arizona, 85258, United States

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Clovis, California, 93611, United States

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Los Angeles, California, 90015, United States

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Orange, California, 92868, United States

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Torrance, California, 90502, United States

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Broomfield, Colorado, 80021, United States

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Chicago, Illinois, 60637, United States

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Skokie, Illinois, 60077, United States

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Indianapolis, Indiana, 46260, United States

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Wichita, Kansas, 67214, United States

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Ann Arbor, Michigan, 48109, United States

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Minneapolis, Minnesota, 55455, United States

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Rochester, Minnesota, 55905, United States

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Jackson, Mississippi, 39216, United States

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Morristown, New Jersey, 07960, United States

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New York, New York, 10029, United States

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New York, New York, 10075, United States

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Charlotte, North Carolina, 28204, United States

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Portland, Oregon, 97239, United States

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Nashville, Tennessee, 37232, United States

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Salt Lake City, Utah, 84112, United States

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Spokane, Washington, 99218, United States

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Adelaide, 5000, Australia

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Benowa, 4217, Australia

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Concord, 2139, Australia

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Darlinghurst, 2010, Australia

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East Melbourne, 3002, Australia

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Fitzroy, 3065, Australia

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Frankston, 3099, Australia

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Kingswood, 2747, Australia

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Nedlands, 6009, Australia

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Leoben, 8700, Austria

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Linz, 4021, Austria

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Salzburg, 5020, Austria

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Sankt Pölten, 3100, Austria

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Vienna, 1090, Austria

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Wels, 4600, Austria

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Edmonton, T6G, Canada

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Montreal, H1T, Canada

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Aalborg, 9100, Denmark

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Albi, 81000, France

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Amiens, 80054, France

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Angers, 49100, France

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Caen, 14000, France

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Carcassonne, 11010, France

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Castres, 81108, France

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Chambéry, 73000, France

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Grenoble, 38043, France

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La Roche-sur-Yon, 85925, France

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Lille, 59020, France

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Montpellier, 34295, France

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Narbonne, 11100, France

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Nice, 06200, France

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Nîmes, 30029, France

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Orléans, 45100, France

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Paris, 75013, France

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Paris, 75015, France

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Perpignan, 66000, France

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Pessac, 33600, France

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Pierre-Bénite, 69495, France

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Quimper, 29107, France

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Rodez, 12027, France

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Rouen, 76031, France

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Saint-Brieuc, 22027, France

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Saint-Priest-en-Jarez, 42271, France

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Saint-Quentin, 02321, France

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Toulouse, 31100, France

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Tours, 37044, France

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Troyes, 10003, France

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Vandœuvre-lès-Nancy, 54500, France

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Aschaffenburg, 63739, Germany

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Augsburg, 86152, Germany

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Bad Liebenwerda, 04924, Germany

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Cologne, 51103, Germany

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Donauwörth, 86609, Germany

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Dresden, 01127, Germany

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Dresden, 01307, Germany

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Flensburg, 24939, Germany

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Frechen, 50226, Germany

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Freiburg im Breisgau, 79106, Germany

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Göttingen, 37073, Germany

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Halle, 06120, Germany

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Hamburg, 22081, Germany

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Hanover, 30161, Germany

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Hanover, 30171, Germany

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Heidelberg, 69115, Germany

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Heilbronn, 74078, Germany

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Landshut, 84036, Germany

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Lebach, 66822, Germany

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Lübeck, 23538, Germany

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Mainz, 55131, Germany

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Münster, 48149, Germany

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Neustadt, 31535, Germany

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Oldenburg, 26121, Germany

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Oldenburg in Holstein, 23758, Germany

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Potsdam, 14467, Germany

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Ratingen, 40878, Germany

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Saarbrücken, 66113, Germany

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Schorndorf, 73614, Germany

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Stuttgart, 70376, Germany

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Villingen-Schwenningen, 78052, Germany

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Wilhelmshaven, 26389, Germany

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Wolfsburg, 38440, Germany

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Alessandria, 15100, Italy

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Ancona, 60126, Italy

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Aviano, 33081, Italy

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Bergamo, 24127, Italy

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Bologna, 40138, Italy

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Como, 22100, Italy

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Cremona, 26100, Italy

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Florence, 50134, Italy

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Lecce, 73100, Italy

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Milan, 20132, Italy

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Modena, 41124, Italy

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Napoli, 80131, Italy

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Palermo, 90146, Italy

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Perugia, 06129, Italy

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Piacenza, 29121, Italy

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Ponderano, 13875, Italy

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Ravenna, 48121, Italy

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Reggio Calabria, 89124, Italy

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Rimini, 47923, Italy

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Roma, 00128, Italy

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Roma, 00161, Italy

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Roma, 00189, Italy

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Terni, 05100, Italy

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Udine, 33100, Italy

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Vicenza, 36100, Italy

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Busan, 49201, South Korea

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Busan, 49241, South Korea

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Seoul, 3080, South Korea

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Seoul, 5505, South Korea

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Seoul, South Korea

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Ulsan, 44033, South Korea

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Badalona, 08916, Spain

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Barcelona, 08035, Spain

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L'Hospitalet de Llobregat, 08908, Spain

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Lugo, 27003, Spain

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Madrid, 28006, Spain

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Madrid, 28007, Spain

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Madrid, 28023, Spain

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Madrid, 28040, Spain

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Madrid, 28050, Spain

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Majadahonda, 28222, Spain

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Palma de Mallorca, 07120, Spain

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Palma de Mallorca, 07198, Spain

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Pamplona, 31008, Spain

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Pozuelo de Alarcón, 28223, Spain

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Sabadell, 08208, Spain

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Salamanca, 37007, Spain

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Santander, 39008, Spain

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Seville, 41013, Spain

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Valencia, 46015, Spain

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Valencia, 46026, Spain

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Valladolid, 47003, Spain

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Valladolid, 47012, Spain

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Taichung, 40705, Taiwan

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Tainan, 71004, Taiwan

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Taipei, 100, Taiwan

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Brighton, BN2, United Kingdom

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Manchester, M20, United Kingdom

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Sunderland, SR4, United Kingdom

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Taunton, TA1, United Kingdom

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Truro, TR1, United Kingdom

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Westcliff-on-Sea, SS0, United Kingdom

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Related Publications (2)

• 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.

  PMID: 37171597 DERIVED

• 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.

  PMID: 35674661 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Eva Waltl

  MorphoSys AG

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2020
• First Posted: January 6, 2021
• Study Start: April 1, 2020
• Primary Completion: May 7, 2021
• Study Completion: May 7, 2021
• Last Updated: October 20, 2021

Record last verified: 2021-10

Locations

AU (6); IT (25); KR (6); US (22); ES (22); CA (2); GB (6); TW (3); FR (30); DE (33); DK (1)