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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
66

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Incidence and Severity of Treatment-emergent Adverse Events (TEAEs)
Time Frame: 6 months approximately
6 months approximately

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
MorphoSys AG

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 11, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 11, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 10, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 11, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 21, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 22, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings