Open Label Study to Evaluate the Safety and Efficacy of Lenalidomide With MOR00208 in Patients With R-R DLBCL

NCT02399085 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: MOR208C2032014-004688-19
• Study Type: interventional
• Target: 81
• Locations: 10 countries
• Sites: 57

Brief Summary

This is a Phase II, Single-Arm, Open-Label, Multicentre Study to Evaluate the Safety and Efficacy of Lenalidomide Combined with MOR00208 in Participants with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R-R DLBCL).

Conditions

Diffuse Large B-cell Lymphoma

Keywords

DLBCL; Efficacy; MOR00208; Tafasitamab; lenalidomide

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Best Objective Response Rate (ORR)

  ORR = complete response \[CR\] + partial response \[PR\]; Independent Radiology/Clinical Review Committee (IRC) Evaluation. ORR after MOR00208 and Lenalidomide combination therapy assessed by the IRC evaluation. ORR was defined as the number of participants of the total number of participants treated with MOR00208 + LEN with CR or PR as best response achieved at any time during the study.

  Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled

Secondary Outcomes (15)

• Duration of Response (DoR) by IRC Evaluation

  Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled

• DoR by Investigator (INV) Evaluation

  Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled

• Progression-free Survival (PFS) by IRC Evaluation

  Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled

• PFS by INV Evaluation

  Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled

• Overall Survival (OS)

  Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled

Study Arms (1)

Tafasitamab (MOR00208) + lenalidomide (LEN)

EXPERIMENTAL

MOR00208: MOR00208 was administered via IV infusion at a dose of 12 mg/kg. For the first three cycles (Cycles 1 to 3) of the study each cycle consisted of a MOR00208 infusion on Day 1, Day 8, Day 15 and Day 22 of the cycle. Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter MOR00208 was administered on a bi-weekly (every 14 days) basis with infusions on Day 1 and Day 15 of each 28-day cycle. LEN: Participants self-administered a starting dose of 25 mg oral LEN daily on Days 1-21 of each cycle, for up to 12 cycles in total. LEN dose could be modified in a de-escalating fashion or discontinued based upon clinical and laboratory findings. On days when both study drugs were given together, LEN was administered prior to MOR00208.

Drug: Tafasitamab; Drug: Lenalidomide

Interventions

Tafasitamab DRUG

12 mg/kg

Also known as: MOR00208

Tafasitamab (MOR00208) + lenalidomide (LEN)

Lenalidomide DRUG

25 mg

Also known as: LEN, Revlimid®

Tafasitamab (MOR00208) + lenalidomide (LEN)

Eligibility Criteria

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

You may qualify if:

• Age \>18 years
• Histologically confirmed diagnosis of DLBCL
• Tumour tissue for central pathology review and correlative studies had to be provided.
• Participants must had:
• relapsed and/or refractory disease
• at least one bidimensionally measurable, PET positive disease site (transverse diameter of ≥1.5 cm and perpendicular diameter of ≥1.0 cm at baseline)
• received at least one, but no more than three previous systemic regimens for the treatment of DLBCL and one therapy line must had included a CD20-targeted therapy
• Eastern Cooperative Oncology Group 0 to 2
• Participants were not considered in the opinion of the investigator eligible, or participants unwilling to undergo intensive salvage therapy including ASCT
• Participants had to meet the following laboratory criteria at screening:
• absolute neutrophil count ≥1.5 × 10˄9/L
• platelet count ≥90 × 10˄9/L
• total serum bilirubin ≤2.5 × ULN or ≤5 × ULN in cases of Glibert's Syndrome or liver involvement by lymphoma
• alanine transaminase, aspartate aminotransferase and alkaline phosphatase ≤3 × ULN or \<5 × ULN in cases of liver involvement
• serum creatinine clearance ≥60 mL/minute

You may not qualify if:

• Participants who had:
• other histological type of lymphoma
• primary refractory DLBCL
• a history of "double/triple hit" genetics
• Participants who had, within 14 days prior to Day 1 dosing:
• not discontinued CD20-targeted therapy, chemotherapy, radiotherapy, investigational anticancer therapy or other lymphoma specific therapy
• underwent major surgery or suffered from significant traumatic injury
• received live vaccines.
• required parenteral antimicrobial therapy for active, intercurrent infections
• Participants who:
• had, in the opinion of the investigator, not recovered sufficiently from the adverse toxic effects of prior therapies
• were previously treated with CD19-targeted therapy or immunomodulatory drugs (IMiDs)® (e.g., thalidomide, LEN)
• had a history of hypersensitivity to compounds of similar biological or chemical composition to MOR00208, IMiDs® and/or the excipients contained in the study drug formulations
• had undergone ASCT within the period ≤ 3 months prior to the signing of the Informed Consent Form. Patients who had a more distant history of ASCT had to exhibit full haematological recovery before enrolment into the study
• had undergone previous allogenic stem cell transplantation

Sponsors & Collaborators

• MorphoSys AG: lead

Study Sites (57)

CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center

Bakersfield, California, 93309, United States

Location

UCLA - David Geffen School of Medicine

Los Angeles, California, 90095, United States

Location

Cancer Care - Torrance Memorial Physician Network

Redondo Beach, California, 90277, United States

Location

Central Coast Medical Oncology Corporation

Santa Maria, California, 93454, United States

Location

St. Mary's Hospital And Regional Medical Center

Grand Junction, Colorado, 81501, United States

Location

Norwalk Hospital

Norwalk, Connecticut, 06856, United States

Location

St. Joseph Mercy Hospital Cancer Care Center

Ypsilanti, Michigan, 48179, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Charleston Hematology Oncology Associates

Charleston, South Carolina, 29414, United States

Location

Tyler Hematology-Oncology

Tyler, Texas, 75701, United States

Location

ZNA Middelheim dep Klinische studies Hematologie

Antwerp, 2020, Belgium

Location

AZ Groeninge-Campus Maria's Voorzienigheid

Kortrijk, 8500, Belgium

Location

Centre Hospitalier Universitaire (CHU) de Liege

Liège, 4000, Belgium

Location

Clinique Universitaire de Mont Godinne

Yvoir, 5530, Belgium

Location

University Hospital Olomouc Hematoonkologicka klinika

Olomouc, 779 00, Czechia

Location

CHU De Clermont Ferrand - Hopital Estaing Service Hematologie Clinique Et Thrapie Cellulaire

Clermont-Ferrand, 63000, France

Location

Centre Hospitalier Universitaire (CHU) De Limoges Hopital Dupuytren

Limoges, 87042, France

Location

Centre Hospitalier Lyon-Sud (CHLS)

Lyon, 69495, France

Location

Hopital Universitaire Necker Enfants Malades Service de Hematologie Adultes

Paris, 75015, France

Location

Universitatsklinikum Essen, Abteilung Haematologie

Essen, 45147, Germany

Location

Krankenhaus Nordwest GmbH - Institut Fuer Klinisch-Onkologische Forschung (IKF)

Frankfurt, 60488, Germany

Location

Klinikum Grosshadern-Klinikum Der Ludwig-Maximilian Universitaet Muenchen

Munich, 81337, Germany

Location

Klinikum Nuernberg Nord Medizinische Klinik 5 Hamatologie

Nuremberg, 90419, Germany

Location

Universitaetsklinikum Wuerzburg

Würzburg, 97080, Germany

Location

Semmelweis Egyetem I. Sz. Belgyogyaszati Klinika-Semmelweis University

Budapest, 1038, Hungary

Location

National Institute of Oncology Hematological Department

Budapest, 1122, Hungary

Location

DEKK, Belgyogyaszati Klinika

Debrecen, 4032, Hungary

Location

Somogy Megyei Kaposi Mor Oktato Korhaz (Kaposi Mor County Hospital)

Kaposvár, 7400, Hungary

Location

Azienda Ospedaliera Univerisitaria Policlinico Consorziale Di Bari UOC Ematologia con Trapianto

Bari, 70124, Italy

Location

Ist.Ematologia E Oncologia Medica L.E A.Seragnoli Azienda Ospedaliero-Universitaria, Policlinico S.Orsola-Malpighi

Bologna, 40138, Italy

Location

Azienda Ospedaliero Universitaria Careggi-S.O.D. Patologia Medica

Florence, 50134, Italy

Location

Azienda Ospedaliero - Universitaria Policlinico di Modena Dip di Medicina Diagnostica, Clinica e di Sanità Pubblica

Modena, 41124, Italy

Location

AOU Maggiore della Cartia

Novara, 28100, Italy

Location

A .O. S. Maria della Misericordia

Perugia, 6132, Italy

Location

Tor Vergata University Department Of Hematology

Roma, 00133, Italy

Location

Az Ospedaliera Santa Maria Facolta di Medicina e Chirurgia

Terni, 5100, Italy

Location

A.O.U. Citta della Salute e della Scienza di Torino

Torino, 10126, Italy

Location

Pratia MCM Krakow

Krakow, 30-510, Poland

Location

Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSWiA z Warmimsko

Olsztyn, 10228, Poland

Location

Szpital Wojewodzk I w Opolu SP ZOZ Oddzial Hematologii i Onkologii Hematologicznej

Opole, 45061, Poland

Location

Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych w Poznaniu im. prof. Ludwika Bierkowskiego

Poznan, 60631, Poland

Location

Szpital Wojewodzki Nr 1 im. Fryderyka Chopina w Rzeszowie

Rzeszów, 35055, Poland

Location

MTZ Clinical Research Sp. z o.o

Warsaw, 02106, Poland

Location

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy Klinika Nowotworow Ukladu Chlonnego Ul.

Warsaw, 02781, Poland

Location

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

Warsaw, 02781, Poland

Location

Hospital Universitari Germans Trias i Pujol (HUGTP)

Badalona, 08916, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Institut Catala D'Oncologia-Hospital Duran Y Reynals

Barcelona, 08097, Spain

Location

Hospital Universitario Fundacion Jimenez Diaz Servicio de Hematologia Unidad de Linformas Oncohealth Institute

Madrid, 28040, Spain

Location

Hospital Universitario Puerta de Hierro de Majadahonda

Madrid, 28222, Spain

Location

Complejo Hospitalario de Navarra (CHN)

Pamplona, 31008, Spain

Location

Hospital Universitario Quiron Salud Madrid

Pozuelo de Alarcón, 28223, Spain

Location

Hospital Universitario Virgen del Rocio, Hospital de la Mujer Servicio de Hematologia

Seville, 41013, Spain

Location

The Royal Bournemouth & Christchurch Hospitals

Bournemouth, BH77DW, United Kingdom

Location

Royal Liverpool University Hospital - Liverpool University Hospitals NHS Foundation Trust

Liverpool, L7 8XP, United Kingdom

Location

Sarah Cannon Research Institute

London, W1G 6AD, United Kingdom

Location

The Newcastle Hospitals NHS Foundation Trust

Newcastle, NE7 7DN, United Kingdom

Location

Related Publications (7)

• Salles G, Duell J, Gonzalez Barca E, Tournilhac O, Jurczak W, Liberati AM, Nagy Z, Obr A, Gaidano G, Andre M, Kalakonda N, Dreyling M, Weirather J, Dirnberger-Hertweck M, Ambarkhane S, Fingerle-Rowson G, Maddocks K. Tafasitamab plus lenalidomide in relapsed or refractory diffuse large B-cell lymphoma (L-MIND): a multicentre, prospective, single-arm, phase 2 study. Lancet Oncol. 2020 Jul;21(7):978-988. doi: 10.1016/S1470-2045(20)30225-4. Epub 2020 Jun 5.

  PMID: 32511983 RESULT

• Duell J, Maddocks KJ, Gonzalez-Barca E, Jurczak W, Liberati AM, De Vos S, Nagy Z, Obr A, Gaidano G, Abrisqueta P, Kalakonda N, Andre M, Dreyling M, Menne T, Tournilhac O, Augustin M, Rosenwald A, Dirnberger-Hertweck M, Weirather J, Ambarkhane S, Salles G. Long-term outcomes from the Phase II L-MIND study of tafasitamab (MOR208) plus lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma. Haematologica. 2021 Sep 1;106(9):2417-2426. doi: 10.3324/haematol.2020.275958.

  PMID: 34196165 RESULT

• Duell J, Obr A, Augustin M, Endell J, Liu H, Geiger S, Silverman IM, Ambarkhane S, Rosenwald A. CD19 expression is maintained in DLBCL patients after treatment with tafasitamab plus lenalidomide in the L-MIND study. Leuk Lymphoma. 2022 Feb;63(2):468-472. doi: 10.1080/10428194.2021.1986219. Epub 2021 Nov 15. No abstract available.

  PMID: 34779360 RESULT

• Duell J, Abrisqueta P, Andre M, Gaidano G, Gonzales-Barca E, Jurczak W, Kalakonda N, Liberati AM, Maddocks KJ, Menne T, Nagy Z, Tournilhac O, Kuffer C, Bakuli A, Amin A, Gurbanov K, Salles G. Tafasitamab for patients with relapsed or refractory diffuse large B-cell lymphoma: final 5-year efficacy and safety findings in the phase II L-MIND study. Haematologica. 2024 Feb 1;109(2):553-566. doi: 10.3324/haematol.2023.283480.

  PMID: 37646664 DERIVED

• Cherng HJ, Westin JR. Broadening the MIND: Tafasitamab and Lenalidomide versus Synthetic Controls. Clin Cancer Res. 2022 Sep 15;28(18):3908-3910. doi: 10.1158/1078-0432.CCR-22-1626.

  PMID: 35861632 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

• Zinzani PL, Rodgers T, Marino D, Frezzato M, Barbui AM, Castellino C, Meli E, Fowler NH, Salles G, Feinberg B, Kurukulasuriya NC, Tillmanns S, Parche S, Dey D, Fingerle-Rowson G, Ambarkhane S, Winderlich M, Nowakowski GS. RE-MIND: Comparing Tafasitamab + Lenalidomide (L-MIND) with a Real-world Lenalidomide Monotherapy Cohort in Relapsed or Refractory Diffuse Large B-cell Lymphoma. Clin Cancer Res. 2021 Nov 15;27(22):6124-6134. doi: 10.1158/1078-0432.CCR-21-1471. Epub 2021 Aug 25.

  PMID: 34433649 DERIVED

Related Links

• CD19 expression is maintained in DLBCL patients after treatment with tafasitamab plus lenalidomide in the L-MIND study
• Tafasitamab plus lenalidomide in relapsed or refractory diffuse large B-cell lymphoma (L-MIND): a multicentre, prospective, single-arm, phase 2 study
• Long-term outcomes from the Phase II L-MIND study of tafasitamab (MOR208) plus lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

tafasitamab; Lenalidomide

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

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Lisa Walz
• Organization: MorphoSys AG

Lisa.Walz@morphosys.com

+49 89 89927 26240

Study Officials

• Johannes Duell, MD

  MorphoSys AG

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2015
• First Posted: March 26, 2015
• Study Start: March 29, 2016
• Primary Completion: November 14, 2022
• Study Completion: April 19, 2023
• Last Updated: October 23, 2023
• Results First Posted: February 5, 2020

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (4); CZ (1); ES (8); GB (4); FR (4); DE (5); US (10); PL (8); HU (4); IT (9)