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

NCT ID: NCT04697160

Last Updated: 2021-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3573 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-01

Study Completion Date

2021-05-07

Brief Summary

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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.

Detailed Description

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

Conditions

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Diffuse Large B Cell Lymphoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients who received systemic therapies for R/R DLBCL

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MorphoSys AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eva Waltl

Role: STUDY_DIRECTOR

MorphoSys AG

Locations

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Scottsdale, Arizona, United States

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Clovis, California, United States

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Los Angeles, California, United States

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Orange, California, United States

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Torrance, California, United States

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Broomfield, Colorado, United States

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Chicago, Illinois, United States

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Skokie, Illinois, United States

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Indianapolis, Indiana, United States

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Wichita, Kansas, United States

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Ann Arbor, Michigan, United States

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Minneapolis, Minnesota, United States

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Rochester, Minnesota, United States

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Jackson, Mississippi, United States

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Morristown, New Jersey, United States

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New York, New York, United States

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New York, New York, United States

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Charlotte, North Carolina, United States

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Portland, Oregon, United States

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Nashville, Tennessee, United States

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Salt Lake City, Utah, United States

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Spokane, Washington, United States

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Adelaide, , Australia

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Benowa, , Australia

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Concord, , Australia

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Darlinghurst, , Australia

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East Melbourne, , Australia

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Fitzroy, , Australia

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Frankston, , Australia

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Kingswood, , Australia

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Nedlands, , Australia

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Leoben, , Austria

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Linz, , Austria

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Salzburg, , Austria

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Sankt Pölten, , Austria

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Vienna, , Austria

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Wels, , Austria

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Edmonton, , Canada

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Montreal, , Canada

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Aalborg, , Denmark

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Albi, , France

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Amiens, , France

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Angers, , France

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Caen, , France

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Carcassonne, , France

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Castres, , France

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Chambéry, , France

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Grenoble, , France

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La Roche-sur-Yon, , France

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Lille, , France

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Montpellier, , France

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Narbonne, , France

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Nice, , France

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Nîmes, , France

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Orléans, , France

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Paris, , France

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Paris, , France

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Perpignan, , France

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Pessac, , France

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Pierre-Bénite, , France

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Quimper, , France

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Rodez, , France

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Rouen, , France

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Saint-Brieuc, , France

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Saint-Priest-en-Jarez, , France

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Saint-Quentin, , France

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Toulouse, , France

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Tours, , France

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Troyes, , France

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Vandœuvre-lès-Nancy, , France

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Aschaffenburg, , Germany

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Augsburg, , Germany

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Bad Liebenwerda, , Germany

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Cologne, , Germany

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Donauwörth, , Germany

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Dresden, , Germany

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Dresden, , Germany

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Flensburg, , Germany

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Frechen, , Germany

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Freiburg im Breisgau, , Germany

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Göttingen, , Germany

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Halle, , Germany

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Hamburg, , Germany

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Hanover, , Germany

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Hanover, , Germany

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Heidelberg, , Germany

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Heilbronn, , Germany

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Landshut, , Germany

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Lebach, , Germany

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Lübeck, , Germany

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Mainz, , Germany

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Münster, , Germany

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Neustadt, , Germany

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Oldenburg, , Germany

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Oldenburg in Holstein, , Germany

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Potsdam, , Germany

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Ratingen, , Germany

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Saarbrücken, , Germany

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Schorndorf, , Germany

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Stuttgart, , Germany

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Villingen-Schwenningen, , Germany

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Wilhelmshaven, , Germany

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Wolfsburg, , Germany

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Alessandria, , Italy

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Ancona, , Italy

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Aviano, , Italy

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Bergamo, , Italy

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Bologna, , Italy

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Como, , Italy

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Cremona, , Italy

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Florence, , Italy

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Lecce, , Italy

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Milan, , Italy

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Modena, , Italy

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Napoli, , Italy

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Palermo, , Italy

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Perugia, , Italy

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Piacenza, , Italy

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Ponderano, , Italy

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Ravenna, , Italy

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Reggio Calabria, , Italy

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Rimini, , Italy

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Roma, , Italy

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Roma, , Italy

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Roma, , Italy

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Terni, , Italy

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Udine, , Italy

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Vicenza, , Italy

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Busan, , South Korea

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Busan, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Ulsan, , South Korea

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Badalona, , Spain

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Barcelona, , Spain

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L'Hospitalet de Llobregat, , Spain

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Lugo, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Majadahonda, , Spain

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Palma de Mallorca, , Spain

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Palma de Mallorca, , Spain

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Pamplona, , Spain

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Pozuelo de Alarcón, , Spain

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Sabadell, , Spain

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Salamanca, , Spain

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Santander, , Spain

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Seville, , Spain

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Valencia, , Spain

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Valencia, , Spain

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Valladolid, , Spain

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Valladolid, , Spain

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Taichung, , Taiwan

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Tainan City, , Taiwan

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Taipei, , Taiwan

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Brighton, , United Kingdom

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Manchester, , United Kingdom

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Sunderland, , United Kingdom

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Taunton, , United Kingdom

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Truro, , United Kingdom

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Westcliff-on-Sea, , United Kingdom

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Countries

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United States Australia Austria Canada Denmark France Germany Italy South Korea Spain Taiwan United Kingdom

References

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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.

Reference Type DERIVED
PMID: 37171597 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35674661 (View on PubMed)

Related Links

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Other Identifiers

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MOR208C213

Identifier Type: -

Identifier Source: org_study_id