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Diffuse Large B-cell LymphomaPhase 2L-MINDNCT02399085

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

A Phase 2 study testing Tafasitamab and Lenalidomide in people with Diffuse Large B-cell Lymphoma, run by MorphoSys AG at 57 sites in 10 countries.

Completed

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

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diffuse Large B-cell Lymphoma
What is being tested?
Tafasitamab and Lenalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
81 participants
Where
57 sitesin 10 countries
Study dates
29 Mar 2016to 19 Apr 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Major Inclusion Criteria:

  1. Age >18 years
  2. Histologically confirmed diagnosis of DLBCL
  3. Tumour tissue for central pathology review and correlative studies had to be provided.
  4. 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
  1. Participants were not considered in the opinion of the investigator eligible, or participants unwilling to undergo intensive salvage therapy including ASCT
  2. 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
  1. Females of childbearing potential (FCBP) must:
  • not be pregnant
  • refrain from breastfeeding and donating blood or oocytes
  • agreed to ongoing pregnancy testing
  • committed to continued abstinence from heterosexual intercourse, or agree to use and be able to comply with the use of double-barrier contraception
  1. Males (if sexually active with a FCBP) had to
  • use an effective barrier method of contraception
  • refrain from donating blood or sperm
  1. In the opinion of the investigator the participants had to:
  • be able and willing to receive adequate prophylaxis and/or therapy for thromboembolic events
  • be able to understand, give written informed consent and comply with all study-related procedures, medication use, and evaluations
  • had no history of noncompliance in relation to medical regimens or not be considered potentially unreliable and/or uncooperative
  • be able to understand the reason for complying with the special conditions of the pregnancy prevention risk management plan and gave written acknowledgement of this.

Major Exclusion Criteria:

  1. Participants who had:
  • other histological type of lymphoma
  • primary refractory DLBCL
  • a history of "double/triple hit" genetics
  1. 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
  1. 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
  • had a history of deep venous thrombosis/embolism, threatening thromboembolism or known thrombophilia or were at a high risk for a thromboembolic event in the opinion of the investigator and who were not willing/able to take venous thromboembolic event prophylaxis during the entire treatment period
  • concurrently used other anti-cancer or experimental treatments
  1. Prior history of malignancies other than DLBCL, unless the participant had been free of the disease for ≥5 years prior to screening.
  2. Participants with:
  • positive hepatitis B and/or C serology.
  • known seropositivity for or history of active viral infection with human immunodeficiency virus (HIV)
  • CNS lymphoma involvement
  • history or evidence of clinically significant cardiovascular, CNS and/or other systemic disease that would in the investigator's opinion preclude participation in the study or compromised the participant's ability to give informed consent.

Trial locations and contacts

57 sites in 10 countries.

57 sites in 10 countries

United States10 sites

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

    Bakersfield, California, 93309

  • Charleston Hematology Oncology Associates

    Charleston, South Carolina, 29414

  • Ohio State University Medical Center

    Columbus, Ohio, 43210

  • St. Mary's Hospital And Regional Medical Center

    Grand Junction, Colorado, 81501

  • UCLA - David Geffen School of Medicine

    Los Angeles, California, 90095

  • Norwalk Hospital

    Norwalk, Connecticut, 06856

  • Cancer Care - Torrance Memorial Physician Network

    Redondo Beach, California, 90277

  • Central Coast Medical Oncology Corporation

    Santa Maria, California, 93454

  • Tyler Hematology-Oncology

    Tyler, Texas, 75701

  • St. Joseph Mercy Hospital Cancer Care Center

    Ypsilanti, Michigan, 48179

Other trials in United States

Italy9 sites

  • Azienda Ospedaliera Univerisitaria Policlinico Consorziale Di Bari UOC Ematologia con Trapianto

    Bari, 70124

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

    Bologna, 40138

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

    Florence, 50134

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

    Modena, 41124

  • AOU Maggiore della Cartia

    Novara, 28100

  • A .O. S. Maria della Misericordia

    Perugia, 6132

  • Tor Vergata University Department Of Hematology

    Roma, 00133

  • Az Ospedaliera Santa Maria Facolta di Medicina e Chirurgia

    Terni, 5100

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

    Torino, 10126

Other trials in Italy

Poland8 sites

  • Pratia MCM Krakow

    Krakow, 30-510

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSWiA z Warmimsko

    Olsztyn, 10228

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

    Opole, 45061

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

    Poznan, 60631

  • Szpital Wojewodzki Nr 1 im. Fryderyka Chopina w Rzeszowie

    Rzeszów, 35055

  • MTZ Clinical Research Sp. z o.o

    Warsaw, 02106

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

    Warsaw, 02781

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

    Warsaw, 02781

Other trials in Poland

Spain8 sites

  • Hospital Universitari Germans Trias i Pujol (HUGTP)

    Badalona, 08916

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Institut Catala D'Oncologia-Hospital Duran Y Reynals

    Barcelona, 08097

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

    Madrid, 28040

  • Hospital Universitario Puerta de Hierro de Majadahonda

    Madrid, 28222

  • Complejo Hospitalario de Navarra (CHN)

    Pamplona, 31008

  • Hospital Universitario Quiron Salud Madrid

    Pozuelo de Alarcón, 28223

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

    Seville, 41013

Other trials in Spain

Germany5 sites

  • Universitatsklinikum Essen, Abteilung Haematologie

    Essen, 45147

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

    Frankfurt, 60488

  • Klinikum Grosshadern-Klinikum Der Ludwig-Maximilian Universitaet Muenchen

    Munich, 81337

  • Klinikum Nuernberg Nord Medizinische Klinik 5 Hamatologie

    Nuremberg, 90419

  • Universitaetsklinikum Wuerzburg

    Würzburg, 97080

Other trials in Germany

Belgium4 sites

  • ZNA Middelheim dep Klinische studies Hematologie

    Antwerp, 2020

  • AZ Groeninge-Campus Maria's Voorzienigheid

    Kortrijk, 8500

  • Centre Hospitalier Universitaire (CHU) de Liege

    Liège, 4000

  • Clinique Universitaire de Mont Godinne

    Yvoir, 5530

Other trials in Belgium

France4 sites

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

    Clermont-Ferrand, 63000

  • Centre Hospitalier Universitaire (CHU) De Limoges Hopital Dupuytren

    Limoges, 87042

  • Centre Hospitalier Lyon-Sud (CHLS)

    Lyon, 69495

  • Hopital Universitaire Necker Enfants Malades Service de Hematologie Adultes

    Paris, 75015

Other trials in France

Hungary4 sites

  • Semmelweis Egyetem I. Sz. Belgyogyaszati Klinika-Semmelweis University

    Budapest, 1038

  • National Institute of Oncology Hematological Department

    Budapest, 1122

  • DEKK, Belgyogyaszati Klinika

    Debrecen, 4032

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

    Kaposvár, 7400

Other trials in Hungary

United Kingdom4 sites

  • The Royal Bournemouth & Christchurch Hospitals

    Bournemouth, BH77DW

  • Royal Liverpool University Hospital - Liverpool University Hospitals NHS Foundation Trust

    Liverpool, L7 8XP

  • Sarah Cannon Research Institute

    London, W1G 6AD

  • The Newcastle Hospitals NHS Foundation Trust

    Newcastle, NE7 7DN

Other trials in United Kingdom

Czechia1 site

  • University Hospital Olomouc Hematoonkologicka klinika

    Olomouc, 779 00

Other trials in Czechia

About this study

Official title: A Phase II, Single-Arm, Open-Label, Multicentre Study to Evaluate the Safety and Efficacy of Lenalidomide Combined With MOR00208 in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R-R DLBCL)

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).

Read the detailed description

The aim of this single-arm, multicentre, open-label Phase II study is to evaluate the Lenalidomide (LEN) combined with Tafasitamab (MOR00208) in adult participants with DLBCL who had relapsed after or were refractory to at least one, but no more than three previous systemic regimens administered for the treatment of their DLBCL and who were not candidates for high-dose chemotherapy and subsequent Autologous stem cell transplants and were thus considered to have exhausted their therapeutic options. One prior therapy line had to include an anti-CD20 targeted therapy (e.g., rituximab [RTX]).

MOR00208 and LEN were administered for up to 12 cycles (28 days each), followed by MOR00208 monotherapy until progression, in participants with at least stable disease or a better response.

Being tested
Tafasitamab, Lenalidomide
Keywords
DLBCL, Efficacy, MOR00208, Tafasitamab, lenalidomide
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.

  • TafasitamabDrug

    Also called MOR00208

    12 mg/kg

  • LenalidomideDrug

    Also called LEN, Revlimid®

    25 mg

Study groups in NCT02399085
Study groupRoleWhat they receive
Tafasitamab (MOR00208) + lenalidomide (LEN)ExperimentalMOR00208: 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.
Receives: Drug: Tafasitamab; Drug: Lenalidomide

What is being measured

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

  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.

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

Secondary outcomes (15)

  1. Duration of Response (DoR) by IRC Evaluation

    DoR [months] = (date of assessment of tumor progression or death - date of assessment of first documented response of (CR or PR) + 1)/30.4375.

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

  2. DoR by Investigator (INV) Evaluation

    DoR [months] = (date of assessment of tumour progression or death - date of assessment of first documented response of (CR or PR) + 1)/30.4375.

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

  3. Progression-free Survival (PFS) by IRC Evaluation

    PFS time was defined as the time (in months) from the date of the first administration of any study drug to the date of tumor progression or death from any cause.

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

  4. PFS by INV Evaluation

    PFS time was defined as the time (in months) from the date of the first administration of any study drug to the date of tumor progression or death from any cause.

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

  5. Overall Survival (OS)

    OS was defined as the time from the date of the first administration of any study drug until death from any cause (documented by the date of death).

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

  6. Disease Control Rate (DCR) by IRC Evaluation

    DCR = CR + PR + SD (Stable disease); IRC Evaluation DCR was defined as the number of participants having CR, PR or SD based on the best objective response achieved at any time during the study.

    Measured: Approximately 2.5 years after first participant enrolled

  7. DCR by INV Evaluation

    DCR = CR + PR + SD (Stable disease); IRC Evaluation DCR was defined as the number of participants having CR, PR or SD based on the best objective response achieved at any time during the study.

    Measured: Approximately 2.5 years after first participant enrolled

  8. Time to Progression (TTP) by IRC Evaluation

    TTP is defined as the time from the first administration of any study drug until documented DLBCL progression or death as a result of lymphoma.

    Measured: Approximately 2.5 years after first participant enrolled

  9. TTP by INV Evaluation

    TTP is defined as the time from the first administration of any study drug until documented DLBCL progression or death as a result of lymphoma.

    Measured: Approximately 2.5 years after first participant enrolled

  10. Time to Next Treatment (TTNT)

    Kaplan-Meier analysis of TTNT in FAS population. TTNT is defined as the time from the first administration of any study drug to the institution of next anti-neoplastic therapy (for any reason including disease progression, treatment toxicity and participant preference) or death of any cause, whatever comes first.

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

  11. Event-free Survival (EFS) by IRC Evaluation

    EFS is defined as the time (in months) from the date of the first administration of any study drug to the date of tumour progression, first initiation of a new non-study anti-neoplastic therapy or death from any cause whichever comes first.

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

  12. Serum Drug Levels of MOR00208

    The pharmacokinetics (PK) profile of MOR00208 was investigated by quantifying serum drug levels at baseline and after repeated IV administrations for up to 24 treatment cycles using sparse sampling.

    MOR00208 PK sample was taken pre-dose and 1 hour ± 10 min after the end of MOR00208 infusion for Cycle 1 to Cycle 23. MOR00208 PK sample (pre-dose only) were taken in odd numbered additional treatment cycles only (e.g., treatment Cycles 13, 15,17, 19, 21, 23).

    Measured: Cycle 1 Days 1, 4, 15 predose and 1 hr post-dose; Cycle 2 Days 1, 15 predose and 1 hr post-dose; Cycle 3 Days 1, 15 predose and 1 hr post-dose; Cycles 4, 5, 6, 7, 9, 11,13, 15, 17, 19, 21, 23 Day 1 predose; End of Treatment

  13. Number of Participants Who Developed Anti-MOR00208 Antibodies

    The Anti-MOR00208 Antibodies were investigated by quantifying serum drug levels at baseline and after repeated intravenous (IV) administrations planned for up to 24 treatment cycles using sparse sampling. Anti-MOR00208 antibody sample (pre-dose only) were taken in odd numbered additional treatment cycles only (e.g., treatment Cycles 13, 15,17, 19, 21,23).

    Measured: Baseline, Up to a maximum of 23 cycles.

  14. Number of Participants That Experienced Treatment-emergent Adverse Events (TEAEs)

    TEAEs are defined as any adverse event reported in the following time interval (including the lower and upper limits): date of first administration of study treatment; date of last administration of study treatment + 30 days, or if they are considered to be related to the study drug.

    Measured: Approximately 6.5 years after first participant enrolled

  15. Severity of Treatment-emergent Adverse Events (TEAEs)

    Number of participants with Severity of TEAEs during MOR00208 and LEN combination therapy.

    Measured: Approximately 6.5 years after first participant enrolled

Timeline

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

  1. First posted26 Mar 2015 (estimated)
  2. Study start29 Mar 2016
  3. Primary completion14 Nov 2022
  4. Study completion19 Apr 2023

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
81 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02399085
Sponsor's protocol ID
MOR208C203
Other IDs
2014-004688-19, 2014
Acronym
L-MIND
Status last verified
Sep 2023
First submitted
13 Mar 2015
Last updated
23 Oct 2023
Data monitoring committee
No
FDA-regulated drug
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 32511983

  • 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.

    PubMed 34196165

  • 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.

    PubMed 34779360

  • 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.

    PubMed 37646664

  • 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.

    PubMed 35861632

  • 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

  • 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.

    PubMed 34433649

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tafasitamab and Lenalidomide in people with Diffuse Large B-cell Lymphoma, run by MorphoSys AG at 57 sites in 10 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 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 57 sites in United States, Italy, Poland, Spain, Germany and 5 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Best Objective Response Rate (ORR) (time frame: Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled). 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 NCT02399085, which also lists 7 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 23 Oct 2023.

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