Lymphoma

Tafasitamab + lenalidomide + R-CHOP versus R-CHOP in newly diagnosed high-intermediate and high risk DLBCL patients

Incyte Study ID:
MOR208C310
CT.gov ID:
NCT04824092
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463 or [email protected]
Recruitment Complete
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Clinical Study Purpose

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

Clinical Study Summary

MEDICAL CONDITION(S)
  • Lymphoma
    • PRODUCT
  • Drug: Tafasitamab
  • Drug: Lenalidomide
  • Drug: Rituximab
  • Drug: Cyclophosphamide
  • Drug: Doxorubicin
  • Drug: Vincristine
  • Drug: Prednisone
  • Drug: Tafasitamab placebo
  • Drug: Lenalidomide placebo
    • COLLABORATORS
    N/A
    DATE
    May 2021 - Jun 2025
    TYPE
    Interventional
    PHASE
    Phase 3
    SEX
    Female & Male
    AGE
    18 - 80 Years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Name
    Contact Us
    Name
    MorphoSys Research Site
    Birmingham, Alabama, US, 35209
    Name
    MorphoSys Research Site
    Daphne, Alabama, US, 36526
    Name
    MorphoSys Research Site
    Anchorage, Alaska, US, 99508
    Name
    MorphoSys Research Site
    Chandler, Arizona, US, 85224
    Name
    MorphoSys Research Site
    Tucson, Arizona, US, 85711
    Name
    MorphoSys Research Site
    Tucson, Arizona, US, 85719

    Key Inclusion and Exclusion Criteria

    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:
    • a. DLBCL, NOS including GCB type, ABC type

    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:

    Protocol Summary

    Incyte Study ID:
    MOR208C310
    Primary Purpose:
    Treatment
    Allocation:
    Randomized
    Study Design:
    Parallel Assignment
    Masking:
    Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
    Interventions:
    Drug
    Enrollment:
    899
    Primary Outcome
    Open

    PFS-INV

    Timeframe: Time from date of randomization until Progressive Disease or death from any cause. In this trial, the primary endpoint is PFS as assessed by the investigator (up to 43 months)

    Secondary Outcome
    Open

    EFS-INV

    Timeframe: From randomization until the first occurrence of disease progression or relapse as assessed by the INV using, start of new anti-lymphoma treatment or death from any cause, whichever occurs first (up to 43 months)

    OS

    Timeframe: From randomization until the date of death from any cause (up to 62 months)

    Metabolic PET-negative CR-rate at EOT by BIRC

    Timeframe: End of treatment, 4–8 weeks after last dose

    Metabolic PET-negative CR-rate at EOT by INV

    Timeframe: End of treatment, 4–8 weeks after last dose

    ORR as per INV at EOT

    Timeframe: 6 ± 2 weeks after End of Treatment

    Time to next anti-lymphoma treatment (TTNT)

    Timeframe: From randomization date to start of next anti-lymphoma therapy (for any reason including disease progression, treatment toxicity, and patient preference) or death due to any cause, whatever comes first (up to 43 months)

    Duration of Complete Response (CR) as assessed by the investigator

    Timeframe: From the date of the first occurrence of a documented CR, to the date of progression, relapse, or death from any cause, whichever is earlier (up to 43 months)

    EFS at 3 years

    Timeframe: 36 months after randomization

    PFS at 3 years

    Timeframe: 36 months after randomization

    OS at 3 years

    Timeframe: 36 months after randomization