for people ages 18-80 (full criteria)
study started
estimated completion
Principal Investigator
by Sven De Vos (ucla)



This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial designed to compare the efficacy and safety of the humanized monoclonal anti CD19 antibody tafasitamab plus lenalidomide in addition to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) versus R-CHOP in previously untreated, high-intermediate and high-risk patients with newly-diagnosed DLBCL

Official Title

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial Comparing the Efficacy and Safety of Tafasitamab Plus Lenalidomide in Addition to R-CHOP Versus R-CHOP in Previously Untreated, High-intermediate and High-risk Patients With Newly-diagnosed Diffuse Large B-cell Lymphoma (DLBCL)


Diffuse Large B-cell Lymphoma, DLBCL, CD19, monoclonal antibody, tafasitamab, lenalidomide, R-CHOP, Lymphoma, B-Cell Lymphoma, Lymphoma, Large B-Cell, Diffuse, Prednisone, Cyclophosphamide, Rituximab, Doxorubicin, Vincristine, Tafasitamab plus lenalidomide in addition to R-CHOP


For people ages 18-80

Major Inclusion Criteria:

  • Previously untreated patients with local biopsy-proven, CD20-positive DLBCL, including one of the following diagnoses by 2016 World Health Organization (WHO) classification of lymphoid neoplasms are eligible:
    1. DLBCL, NOS including GCB type, ABC type
    2. T-cell rich large BCL
    3. Epstein-Barr virus-positive DLBCL, NOS
    4. Anaplastic lymphoma kinase (ALK)-positive large BCL
    5. Human herpes virus-8 (HHV8)-positive DLBCL, NOS
    6. High-grade BCL with MYC and B-cell lymphoma 2 (BCL2) and/or B-cell lymphoma 6 (BCL6) rearrangements (double-hit or triple-hit lymphoma). Please note: Patients must be appropriate candidates for R-CHOP. If an investigator deems a patient with a known double- or triple-hit lymphoma (HGBL) should be treated more aggressively (e.g. dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab [DA-EPOCH-R] or cyclophosphamide, vincristine, doxorubicin and dexamethasone (CVAD) followed by methotrexate and cytarabine [Hyper CVAD]), this patient would not be considered eligible for this study
    7. HGBL-NOS
    8. DLBCL coexistent with either follicular lymphoma (FL) of any grade, gastric MALT lymphoma or non-gastric MALT lymphoma
    9. FL grade 3b
  • Availability of archival or freshly collected tumor tissue sent for retrospective central pathology review
  • IPI status of 3 to 5 (for patients > 60 years of age) or aaIPI 2 to 3 (for patients ≤ 60 years of age)
  • Diagnosis to treatment interval, defined as the time between the date of DLBCL diagnosis (date of the first biopsy specimen containing B Cell lymphoma according to the local pathology report) and the start of treatment (C1D1) ≤ 28 days
  • ECOG performance status of 0, 1, or 2
  • Left ventricular ejection fraction equal to or greater 50% as assessed by local echocardiography or cardiac multi-gated acquisition (MUGA) scan
  • Adequate hematologic function
  • Female participants: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods and refrain from breast feeding and donating eggs; agreement to ongoing pregnancy testing during the course of the study, and after study therapy has ended
  • Male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom and agreement to refrain from donating sperm

Major Exclusion Criteria:

  • Any other histological type of lymphoma according to WHO 2016 classification of lymphoid neoplasms, e.g., primary mediastinal (thymic) large B-cell lymphoma, Burkitt's lymphoma, BCL, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma (grey-zone lymphoma); primary effusion lymphoma; primary cutaneous DLBCL, leg type; primary DLBCL of the CNS; DLBCL arising from CLL or indolent lymphoma
  • History of prior non-hematologic malignancy except for the following:
    1. Malignancy treated with curative intent and with no evidence of active disease present for more than 2 years before screening
    2. Adequately treated lentigo maligna melanoma without current evidence of disease or adequately controlled non-melanomatous skin cancer
    3. Adequately treated carcinoma in situ without current evidence of disease
  • Any systemic anti-lymphoma and/or investigational therapy prior to the start of C1D1, except for permitted pre-phase treatment
  • Contraindication to any of the individual components of R-CHOP, including prior receipt of anthracyclines
  • Known CNS lymphoma involvement
  • Known active systemic bacterial, viral, fungal, or other infection at screening, including patients with suspected active or latent tuberculosis (as confirmed by a positive interferon-gamma release assay)
  • History or evidence of clinically significant cardiovascular, CNS and/or other systemic disease that in the investigator's opinion would preclude participation in the study or compromise the patient's ability to give informed consent


  • MorphoSys Research Site
    Clovis California 93611 United States
  • MorphoSys Research Site
    San Diego California 92123 United States
  • MorphoSys Research Site
    Los Angeles California 90017 United States
  • MorphoSys Research Site
    Anaheim California 92801 United States
  • MorphoSys Research Site
    Fullerton California 92834-4138 United States
  • MorphoSys Research Site
    Harbor City California 90710 United States
  • MorphoSys Research Site
    Whittier California 90603 United States

Lead Scientist at University of California Health

  • Sven De Vos (ucla)
    HS Clinical Professor, Medicine. Authored (or co-authored) 10 research publications


in progress, not accepting new patients
Start Date
Completion Date
MorphoSys AG
Phase 3 research study
Study Type
About 899 people participating
Last Updated