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

NCT04134936 | Completed Phase 1 Results FDA Drug

• 1 other identifier: MOR208C107
• Study Type: interventional
• Target: 66
• Locations: 9 countries
• Sites: 70

Brief 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 diagnosed, previously untreated Diffuse Large B-cell Lymphoma (DLBCL).

Conditions

Diffuse Large B-cell Lymphoma

Keywords

DLBCL; CD19; monoclonal antibody; tafasitamab; lenalidomide; MOR208; MOR00208

Outcome Measures

Primary Outcomes (1)

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

  6 months approximately

Secondary Outcomes (10)

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

  6 months approximately

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

  6 months approximately

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

  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)

  24 months approximately

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

  24 months approximately

Study Arms (2)

Arm A

EXPERIMENTAL

Tafasitamab in addition to R-CHOP

Drug: Tafasitamab

Arm B

EXPERIMENTAL

Tafasitamab plus lenalidomide in addition to R-CHOP

Drug: Tafasitamab plus lenalidomide

Interventions

Tafasitamab DRUG

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

Arm A

Tafasitamab plus lenalidomide DRUG

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

Arm B

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, not otherwise specified (NOS)
• Tumor tissue for retrospective central pathology review and correlative studies must be provided.
• At least one bidimensionally measurable, PET positive disease site (greatest transverse diameter of ≥1.5 cm, greatest perpendicular diameter of ≥1.0 cm)
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
• International Prognostic Index (IPI) status of 2 to 5
• Appropriate candidate for R-CHOP
• Left ventricular ejection fraction (LVEF) of ≥50% assessed by echocardiography or cardiac multi-gated acquisition (MUGA) scan
• Adequate hematologic, liver and renal function
• 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
• Males must:

You may not qualify if:

• Any other histological type of lymphoma according to World Health Organization (WHO) 2016 classification of lymphoid neoplasms, known double- or triple-hit lymphoma
• Transformed non-Hodgkin lymphoma (NHL) and/or evidence of composite lymphoma
• History of radiation therapy to ≥25% of the bone marrow or history of anthracycline therapy
• 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
• History of myocardial infarction ≤6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening arrhythmias
• 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

Sponsors & Collaborators

• MorphoSys AG: lead

Study Sites (70)

MorphoSys Research Site

Tucson, Arizona, 85711, United States

Location

MorphoSys Research Site

Anaheim, California, 92801, United States

Location

MorphoSys Research Site

Duarte, California, 91010, United States

Location

MorphoSys Research Site

Encinitas, California, 92024, United States

Location

MorphoSys Research Site

Aurora, Colorado, 80012, United States

Location

MorphoSys Research Site

New Haven, Connecticut, 06520, United States

Location

MorphoSys Research Site

Washington D.C., District of Columbia, 20037, United States

Location

MorphoSys Research Site

Urbana, Illinois, 61801, United States

Location

MorphoSys Research Site

Louisville, Kentucky, 40207, United States

Location

MorphoSys Research Site

Covington, Louisiana, 70433, United States

Location

MorphoSys Research Site

Rockville, Maryland, 20850, United States

Location

MorphoSys Research Site

Ann Arbor, Michigan, 48109-5864, United States

Location

MorphoSys Research Site

Rochester, Minnesota, 55905, United States

Location

MorphoSys Research Site

Cincinnati, Ohio, 45236, United States

Location

MorphoSys Research Site

Cleveland, Ohio, 44106, United States

Location

MorphoSys Research Site

Eugene, Oregon, 97401, United States

Location

MorphoSys Research Site

Charleston, South Carolina, 29425, United States

Location

MorphoSys Research Site

Austin, Texas, 78705, United States

Location

MorphoSys Research Site

Dallas, Texas, 75246, United States

Location

MorphoSys Research Site

Houston, Texas, 77030, United States

Location

MorphoSys Research Site

San Antonio, Texas, 78240, United States

Location

MorphoSys Research Site

Tyler, Texas, 75702, United States

Location

MorphoSys Research Site

Vancouver, Washington, 98684, United States

Location

MorphoSys Research Site

Graz, A-8036, Austria

Location

MorphoSys Research Site

Innsbruck, 6020, Austria

Location

MorphoSys Research Site

Linz, 4010, Austria

Location

MorphoSys Research Site

Salzburg, 5020, Austria

Location

MorphoSys Research Site

Sankt Pölten, 3100, Austria

Location

MorphoSys Research Site

Vienna, 1090, Austria

Location

MorphoSys Research Site

Wels, 4600, Austria

Location

MorphoSys Research Site

Antwerp, 2060, Belgium

Location

MorphoSys Research Site

Antwerp, 2610, Belgium

Location

MorphoSys Research Site

Brussels, 1090, Belgium

Location

MorphoSys Research Site

Ghent, 9000, Belgium

Location

MorphoSys Research Site

Roeselare, 8800, Belgium

Location

MorphoSys Research Site

Yvoir, 5530, Belgium

Location

MorphoSys Research Site

Hradec Králové, 50005, Czechia

Location

MorphoSys Research Site

Ostrava, 708 52, Czechia

Location

MorphoSys Research Site

Prague, 100 34, Czechia

Location

MorphoSys Research Site

Prague, 12808, Czechia

Location

MorphoSys Research Site

Prague, 15006, Czechia

Location

MorphoSys Research Site

Bordeaux, France

Location

MorphoSys Research Site

Brest, France

Location

MorphoSys Research Site

Nantes, France

Location

MorphoSys Research Site

Pierre-Bénite, France

Location

MorphoSys Research Site

Aachen, 52074, Germany

Location

MorphoSys Research Site

Augsburg, 86156, Germany

Location

MorphoSys Research Site

Bonn, 53127, Germany

Location

MorphoSys Research Site

Dortmund, 44137, Germany

Location

MorphoSys Research Site

Giessen, 35391, Germany

Location

MorphoSys Research Site

Göttingen, 37075, Germany

Location

MorphoSys Research Site

Halle, 6120, Germany

Location

MorphoSys Research Site

Mutlangen, 73557, Germany

Location

MorphoSys Research Site

München, 80634, Germany

Location

MorphoSys Research Site

München, 81377, Germany

Location

MorphoSys Research Site

Nuremberg, 90419, Germany

Location

MorphoSys Research Site

Würzburg, 97080, Germany

Location

MorphoSys Research Site

Bologna, Italy

Location

MorphoSys Research Site

Ravenna, Italy

Location

MorphoSys Research Site

Lisbon, 1099-023, Portugal

Location

MorphoSys Research Site

Lisbon, 1400-038, Portugal

Location

MorphoSys Research Site

Porto, 4200-072, Portugal

Location

MorphoSys Research Site

Porto, 4200-319, Portugal

Location

MorphoSys Research Site

Barcelona, Spain

Location

MorphoSys Research Site

Cáceres, Spain

Location

MorphoSys Research Site

Girona, Spain

Location

MorphoSys Research Site

Madrid, Spain

Location

MorphoSys Research Site

Sabadell, Spain

Location

MorphoSys Research Site

Seville, Spain

Location

MorphoSys Research Site

Vitoria-Gasteiz, Spain

Location

Related Publications (2)

• 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.

  PMID: 40802906 DERIVED

• 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.

  PMID: 37369099 DERIVED

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: Medical Information
• Organization: MorphoSys

medinfo@morphosys.com

+1 844 667-1992

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2019
• First Posted: October 22, 2019
• Study Start: December 11, 2019
• Primary Completion: February 11, 2021
• Study Completion: August 10, 2022
• Last Updated: October 16, 2024
• Results First Posted: October 16, 2024

Record last verified: 2024-10

Locations

BE (6); IT (2); ES (7); FR (4); PT (4); CZ (5); US (23); DE (12); AU (7)