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Diffuse Large B-cell LymphomaPhase 1NCT04134936

Phase Ib Study to Assess Safety and Preliminary Efficacy of Tafasitamab or Tafasitamab Plus Lenalidomide in Addition to R-CHOP in Patients With Newly Diagnosed DLBCL

A Phase 1 study testing Tafasitamab and Tafasitamab plus lenalidomide in people with Diffuse Large B-cell Lymphoma, run by MorphoSys AG at 70 sites in 9 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 an open-label, randomized, multicentre study to evaluate safety and preliminary efficacy of the human anti-CD19 antibody Tafasitamab in addition to R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone) or Tafasitamab and Lenalidomide in addition to R-CHOP in adult patients with newly… 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 Tafasitamab plus lenalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
70 sitesin 9 countries
Study dates
11 Dec 2019to 10 Aug 2022
Phase
Phase 1
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, not otherwise specified (NOS)
  3. Tumor tissue for retrospective central pathology review and correlative studies must be provided.
  4. At least one bidimensionally measurable, PET positive disease site (greatest transverse diameter of ≥1.5 cm, greatest perpendicular diameter of ≥1.0 cm)
  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  6. International Prognostic Index (IPI) status of 2 to 5
  7. Appropriate candidate for R-CHOP
  8. Left ventricular ejection fraction (LVEF) of ≥50% assessed by echocardiography or cardiac multi-gated acquisition (MUGA) scan
  9. Adequate hematologic, liver and renal function
  10. Females of childbearing potential (FCBP) must:
  • not be pregnant
  • refrain from breast feeding and donating oocyte
  • agree to ongoing pregnancy testing
  • commit to continued abstinence from heterosexual intercourse, or agree to use and be able to comply with the use of double-barrier contraception
  1. Males must:
  • use an effective barrier method of contraception if sexually active with FCBP
  • refrain from donating sperm
  1. In the opinion of investigator, the patient must be able and willing to receive adequate prophylaxis and/or therapy for thromboembolic events

Major Exclusion Criteria:

  1. Any other histological type of lymphoma according to World Health Organization (WHO) 2016 classification of lymphoid neoplasms, known double- or triple-hit lymphoma
  2. Transformed non-Hodgkin lymphoma (NHL) and/or evidence of composite lymphoma
  3. History of radiation therapy to ≥25% of the bone marrow or history of anthracycline therapy
  4. History of prior non-hematologic malignancy except for the following:
  • Malignancy treated with curative intent and with no evidence of active disease present for more than 2 years before screening
  • Adequately treated lentigo maligna melanoma without current evidence of disease or adequately controlled non-melanomatous skin cancer
  • Adequately treated carcinoma in situ without current evidence of disease
  1. History of myocardial infarction ≤6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening arrhythmias
  2. Patients with:
  • positive test results for active hepatitis B and C
  • known seropositive for or history of active viral infection with human immunodeficiency virus (HIV)
  • known active bacterial, viral, fungal, mycobacterial, or other infection at screening
  • known central nervous system (CNS) lymphoma involvement
  • history or evidence of clinically significant cardiovascular, CNS and/or other systemic disease that would in the investigator opinion preclude participation in the study

Trial locations and contacts

70 sites in 9 countries.

70 sites in 9 countries

United States23 sites

  • MorphoSys Research Site

    Anaheim, California, 92801

  • MorphoSys Research Site

    Ann Arbor, Michigan, 48109-5864

  • MorphoSys Research Site

    Aurora, Colorado, 80012

  • MorphoSys Research Site

    Austin, Texas, 78705

  • MorphoSys Research Site

    Charleston, South Carolina, 29425

  • MorphoSys Research Site

    Cincinnati, Ohio, 45236

  • MorphoSys Research Site

    Cleveland, Ohio, 44106

  • MorphoSys Research Site

    Covington, Louisiana, 70433

  • MorphoSys Research Site

    Dallas, Texas, 75246

  • MorphoSys Research Site

    Duarte, California, 91010

  • MorphoSys Research Site

    Encinitas, California, 92024

  • MorphoSys Research Site

    Eugene, Oregon, 97401

  • MorphoSys Research Site

    Houston, Texas, 77030

  • MorphoSys Research Site

    Louisville, Kentucky, 40207

  • MorphoSys Research Site

    New Haven, Connecticut, 06520

  • MorphoSys Research Site

    Rochester, Minnesota, 55905

  • MorphoSys Research Site

    Rockville, Maryland, 20850

  • MorphoSys Research Site

    San Antonio, Texas, 78240

  • MorphoSys Research Site

    Tucson, Arizona, 85711

  • MorphoSys Research Site

    Tyler, Texas, 75702

  • MorphoSys Research Site

    Urbana, Illinois, 61801

  • MorphoSys Research Site

    Vancouver, Washington, 98684

  • MorphoSys Research Site

    Washington D.C., District of Columbia, 20037

Other trials in United States

Germany12 sites

  • MorphoSys Research Site

    Aachen, 52074

  • MorphoSys Research Site

    Augsburg, 86156

  • MorphoSys Research Site

    Bonn, 53127

  • MorphoSys Research Site

    Dortmund, 44137

  • MorphoSys Research Site

    Giessen, 35391

  • MorphoSys Research Site

    Göttingen, 37075

  • MorphoSys Research Site

    Halle, 6120

  • MorphoSys Research Site

    München, 80634

  • MorphoSys Research Site

    München, 81377

  • MorphoSys Research Site

    Mutlangen, 73557

  • MorphoSys Research Site

    Nuremberg, 90419

  • MorphoSys Research Site

    Würzburg, 97080

Other trials in Germany

Austria7 sites

  • MorphoSys Research Site

    Graz, A-8036

  • MorphoSys Research Site

    Innsbruck, 6020

  • MorphoSys Research Site

    Linz, 4010

  • 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

Spain7 sites

  • MorphoSys Research Site

    Barcelona

  • MorphoSys Research Site

    Cáceres

  • MorphoSys Research Site

    Girona

  • MorphoSys Research Site

    Madrid

  • MorphoSys Research Site

    Sabadell

  • MorphoSys Research Site

    Seville

  • MorphoSys Research Site

    Vitoria-Gasteiz

Other trials in Spain

Belgium6 sites

  • MorphoSys Research Site

    Antwerp, 2060

  • MorphoSys Research Site

    Antwerp, 2610

  • MorphoSys Research Site

    Brussels, 1090

  • MorphoSys Research Site

    Ghent, 9000

  • MorphoSys Research Site

    Roeselare, 8800

  • MorphoSys Research Site

    Yvoir, 5530

Other trials in Belgium

Czechia5 sites

  • MorphoSys Research Site

    Hradec Králové, 50005

  • MorphoSys Research Site

    Ostrava, 708 52

  • MorphoSys Research Site

    Prague, 100 34

  • MorphoSys Research Site

    Prague, 12808

  • MorphoSys Research Site

    Prague, 15006

Other trials in Czechia

France4 sites

  • MorphoSys Research Site

    Bordeaux

  • MorphoSys Research Site

    Brest

  • MorphoSys Research Site

    Nantes

  • MorphoSys Research Site

    Pierre-Bénite

Other trials in France

Portugal4 sites

  • MorphoSys Research Site

    Lisbon, 1099-023

  • MorphoSys Research Site

    Lisbon, 1400-038

  • MorphoSys Research Site

    Porto, 4200-072

  • MorphoSys Research Site

    Porto, 4200-319

Other trials in Portugal

Italy2 sites

  • MorphoSys Research Site

    Bologna

  • MorphoSys Research Site

    Ravenna

Other trials in Italy

About this study

Official title: A Phase Ib, Open-label, Randomized Study to Assess Safety and Preliminary Efficacy of Tafasitamab in Addition to R-CHOP or Tafasitamab Plus Lenalidomide in Addition to R-CHOP in Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL) - First-MIND

This is an open-label, randomized, multicentre study to evaluate safety and preliminary efficacy of the human anti-CD19 antibody Tafasitamab in addition to R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone) or Tafasitamab and Lenalidomide in addition to R-CHOP in adult patients with newly diagnosed, previously untreated Diffuse Large B-cell Lymphoma (DLBCL).

Being tested
Tafasitamab, Tafasitamab plus lenalidomide
Keywords
DLBCL, CD19, monoclonal antibody, tafasitamab, lenalidomide, MOR208, MOR00208
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

    Six 21-day cycles of tafasitamab (12 mg/kg intravenously, on Day 1, 8 and 15) in addition to R-CHOP

  • Tafasitamab plus lenalidomideDrug

    Six 21-day cycles of tafasitamab (12 mg/kg intravenously, on Day 1, 8 and 15) plus lenalidomide (starting dose 25 mg orally, on Day 1-10) in addition to R-CHOP

Study groups in NCT04134936
Study groupRoleWhat they receive
Arm AExperimentalTafasitamab in addition to R-CHOP
Receives: Drug: Tafasitamab
Arm BExperimentalTafasitamab plus lenalidomide in addition to R-CHOP
Receives: Drug: Tafasitamab plus lenalidomide

What is being measured

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

  1. Incidence and Severity of Treatment-emergent Adverse Events (TEAEs)

    Measured: 6 months approximately

Secondary outcomes (10)

  1. Objective Response Rate (ORR) at the End of Treatment (EOT)

    The ORR at EOT was defined as the proportion of patients with Complete Response (CR) or Partial response (PR) based on the response achieved at the EOT Visit/early treatment discontinuation visit.

    Measured: 6 months approximately

  2. Metabolic, PET-negative Complete Response (CR) Rate at the End of Treatment

    Measured: 6 months approximately

  3. Incidence and Severity of Adverse Events (AEs) in the Follow-up (FU) Period

    Measured: 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events

  4. Best Objective Response Rate (ORR) Until the End of Study (EOS)

    The best ORR was defined as the proportion of patients with Complete Response (CR) or Partial Response (PR) as the best response until the EOS.

    Measured: 24 months approximately

  5. Metabolic, PET-negative Complete Response (CR) Rate Until the End of Study

    Measured: 24 months approximately

  6. Progression-free Survival (PFS) at 12 and 24 Months

    As many patients had their data censored, due to completing the study without disease progression or death due to any cause, the probability of PFS (%) was used.

    Measured: 24 months approximately

  7. Event-free Survival (EFS) at 12 and 24 Months

    As many patients had their data censored, due to completing the study without disease progression, death due to any cause, or the start of a new anti-lymphoma treatment, the probability of EFS (%) was used.

    Measured: 24 months approximately

  8. Time to Next Anti-lymphoma Treatment (TTNT)

    As many patients had their data censored, due to completing the study without needing to receive another anti-lymphoma treatment, the Probability of TTNT (%) was used. Time to next anti-lymphoma treatment survival % estimate was the estimated probability that a patient remained TTNT-free up to the specified point in time.

    Measured: 24 months approximately

  9. Overall Survival at 12 and 24 Months

    As many patients had their data censored, due to completing the study without death from any cause, the probability of OS (%) was used.

    Measured: 24 months approximately

  10. Anti-tafasitamab Antibodies Formation

    Measured: 12 months approximately

Timeline

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

  1. First posted22 Oct 2019
  2. Study start11 Dec 2019
  3. Primary completion11 Feb 2021
  4. Study completion10 Aug 2022

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04134936
Sponsor's protocol ID
MOR208C107
Status last verified
Oct 2024
First submitted
11 Oct 2019
Last updated
16 Oct 2024
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Roschewski M, Kurtz DM, Westin JR, Lynch RC, Gopal AK, Alig SK, Sworder BJ, Cherng HJ, Kuffer C, Blair D, Brown K, Goldstein JS, Schultz A, Close S, Chabon JJ, Diehn M, Wilson WH, Alizadeh AA. Remission Assessment by Circulating Tumor DNA in Large B-Cell Lymphoma. J Clin Oncol. 2025 Dec;43(34):3652-3661. doi: 10.1200/JCO-25-01534. Epub 2025 Aug 13.

    PubMed 40802906

  • Belada D, Kopeckova K, Bergua Burgues JM, Stevens D, Andre M, Persona EP, Pichler P, Staber PB, Trneny M, Duell J, Waldron-Lynch M, Wagner S, Mukhopadhyay A, Dirnberger-Hertweck M, Burke JM, Nowakowski GS. Safety and efficacy of tafasitamab with or without lenalidomide added to first-line R-CHOP for DLBCL: the phase 1b First-MIND study. Blood. 2023 Oct 19;142(16):1348-1358. doi: 10.1182/blood.2023020637.

    PubMed 37369099

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Tafasitamab and Tafasitamab plus lenalidomide in people with Diffuse Large B-cell Lymphoma, run by MorphoSys AG at 70 sites in 9 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 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 70 sites in United States, Germany, Austria, Spain, Belgium and 4 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 16 Oct 2024). 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?

Incidence and Severity of Treatment-emergent Adverse Events (TEAEs) (time frame: 6 months approximately). 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 NCT04134936, 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 16 Oct 2024.

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