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

October 11, 2024 updated by: MorphoSys AG

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, A-8036
        • MorphoSys Research Site
      • Innsbruck, Austria, 6020
        • MorphoSys Research Site
      • Linz, Austria, 4010
        • MorphoSys Research Site
      • Salzburg, Austria, 5020
        • MorphoSys Research Site
      • St. Poelten, Austria, 3100
        • MorphoSys Research Site
      • Vienna, Austria, 1090
        • MorphoSys Research Site
      • Wels, Austria, 4600
        • MorphoSys Research Site
  • Belgium
      • Antwerpen, Belgium, 2060
        • MorphoSys Research Site
      • Antwerpen, Belgium, 2610
        • MorphoSys Research Site
      • Brussel, Belgium, 1090
        • MorphoSys Research Site
      • Gent, Belgium, 9000
        • MorphoSys Research Site
      • Roeselare, Belgium, 8800
        • MorphoSys Research Site
      • Yvoir, Belgium, 5530
        • MorphoSys Research Site
  • Czechia
      • Hradec Králové, Czechia, 50005
        • MorphoSys Research Site
      • Ostrava, Czechia, 708 52
        • MorphoSys Research Site
      • Prague, Czechia, 100 34
        • MorphoSys Research Site
      • Prague, Czechia, 12808
        • MorphoSys Research Site
      • Prague, Czechia, 15006
        • MorphoSys Research Site
  • France
      • Bordeaux 33076, France
        • MorphoSys Research Site
      • Brest 29609, France
        • MorphoSys Research Site
      • Nantes 44093, France
        • MorphoSys Research Site
      • Pierre Benite 69310, France
        • MorphoSys Research Site
  • Germany
      • Aachen, Germany, 52074
        • MorphoSys Research Site
      • Augsburg, Germany, 86156
        • MorphoSys Research Site
      • Bonn, Germany, 53127
        • MorphoSys Research Site
      • Dortmund, Germany, 44137
        • MorphoSys Research Site
      • Gießen, Germany, 35391
        • MorphoSys Research Site
      • Göttingen, Germany, 37075
        • MorphoSys Research Site
      • Halle, Germany, 6120
        • MorphoSys Research Site
      • Mutlangen, Germany, 73557
        • MorphoSys Research Site
      • München, Germany, 80634
        • MorphoSys Research Site
      • München, Germany, 81377
        • MorphoSys Research Site
      • Nürnberg, Germany, 90419
        • MorphoSys Research Site
      • Würzburg, Germany, 97080
        • MorphoSys Research Site
  • Italy
      • Bologna 40138, Italy
        • MorphoSys Research Site
      • Ravenna 48100, Italy
        • MorphoSys Research Site
  • Portugal
      • Lisboa, Portugal, 1099-023
        • MorphoSys Research Site
      • Lisbon, Portugal, 1400-038
        • MorphoSys Research Site
      • Porto, Portugal, 4200-072
        • MorphoSys Research Site
      • Porto, Portugal, 4200-319
        • MorphoSys Research Site
  • Spain
      • Barcelona 8003, Spain
        • MorphoSys Research Site
      • Caceres 10003, Spain
        • MorphoSys Research Site
      • Girona 17007, Spain
        • MorphoSys Research Site
      • Madrid 28041, Spain
        • MorphoSys Research Site
      • Sabadell 8208, Spain
        • MorphoSys Research Site
      • Sevilla 41013, Spain
        • MorphoSys Research Site
      • Vitoria-Gasteiz 1009, Spain
        • MorphoSys Research Site
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85711
        • MorphoSys Research Site
    • California
      • Anaheim, California, United States, 92801
        • MorphoSys Research Site
      • Duarte, California, United States, 91010
        • MorphoSys Research Site
      • Encinitas, California, United States, 92024
        • MorphoSys Research Site
    • Colorado
      • Aurora, Colorado, United States, 80012
        • MorphoSys Research Site
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • MorphoSys Research Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • MorphoSys Research Site
    • Illinois
      • Urbana, Illinois, United States, 61801
        • MorphoSys Research Site
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • MorphoSys Research Site
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • MorphoSys Research Site
    • Maryland
      • Rockville, Maryland, United States, 20850
        • MorphoSys Research Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-5864
        • MorphoSys Research Site
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • MorphoSys Research Site
    • Ohio
      • Cincinnati, Ohio, United States, 45236
        • MorphoSys Research Site
      • Cleveland, Ohio, United States, 44106
        • MorphoSys Research Site
    • Oregon
      • Eugene, Oregon, United States, 97401
        • MorphoSys Research Site
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • MorphoSys Research Site
    • Texas
      • Austin, Texas, United States, 78705
        • MorphoSys Research Site
      • Dallas, Texas, United States, 75246
        • MorphoSys Research Site
      • Houston, Texas, United States, 77030
        • MorphoSys Research Site
      • San Antonio, Texas, United States, 78240
        • MorphoSys Research Site
      • Tyler, Texas, United States, 75702
        • MorphoSys Research Site
    • Washington
      • Vancouver, Washington, United States, 98684
        • MorphoSys Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

  11. Males must:

    • use an effective barrier method of contraception if sexually active with FCBP
    • refrain from donating sperm
  12. 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
  5. History of myocardial infarction ≤6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening arrhythmias

  6. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
Tafasitamab in addition to R-CHOP
Drug: Tafasitamab
Six 21-day cycles of tafasitamab (12 mg/kg intravenously, on Day 1, 8 and 15) in addition to R-CHOP
Experimental: Arm B
Tafasitamab plus lenalidomide in addition to R-CHOP
Drug: Tafasitamab plus lenalidomide
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence and Severity of Treatment-emergent Adverse Events (TEAEs)
Time Frame: 6 months approximately
6 months approximately

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR) at the End of Treatment (EOT)
Time Frame: 6 months approximately
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.
6 months approximately
Metabolic, PET-negative Complete Response (CR) Rate at the End of Treatment
Time Frame: 6 months approximately
6 months approximately
Incidence and Severity of Adverse Events (AEs) in the Follow-up (FU) Period
Time Frame: 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events
18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events
Best Objective Response Rate (ORR) Until the End of Study (EOS)
Time Frame: 24 months approximately
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.
24 months approximately
Metabolic, PET-negative Complete Response (CR) Rate Until the End of Study
Time Frame: 24 months approximately
24 months approximately
Progression-free Survival (PFS) at 12 and 24 Months
Time Frame: 24 months approximately
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.
24 months approximately
Event-free Survival (EFS) at 12 and 24 Months
Time Frame: 24 months approximately
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.
24 months approximately
Time to Next Anti-lymphoma Treatment (TTNT)
Time Frame: 24 months approximately
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.
24 months approximately
Overall Survival at 12 and 24 Months
Time Frame: 24 months approximately
As many patients had their data censored, due to completing the study without death from any cause, the probability of OS (%) was used.
24 months approximately
Anti-tafasitamab Antibodies Formation
Time Frame: 12 months approximately
12 months approximately

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MorphoSys AG

Investigators

  • Study Director: Pia Kloepfer, MD, MorphoSys AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 11, 2019

Primary Completion (Actual)

February 11, 2021

Study Completion (Actual)

August 10, 2022

Study Registration Dates

First Submitted

October 11, 2019

First Submitted That Met QC Criteria

October 21, 2019

First Posted (Actual)

October 22, 2019

Study Record Updates

Last Update Posted (Actual)

October 16, 2024

Last Update Submitted That Met QC Criteria

October 11, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOR208C107

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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