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)
Description
Brief Summary
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
Phase
N/AInclusion and Exclusion 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:
- DLBCL, NOS including GCB type, ABC type
- T-cell rich large BCL
- Epstein-Barr virus-positive DLBCL, NOS
- Anaplastic lymphoma kinase (ALK)-positive large BCL
- Human herpes virus-8 (HHV8)-positive DLBCL, NOS
- 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
- HGBL-NOS
- DLBCL coexistent with either follicular lymphoma (FL) of any grade, gastric MALT lymphoma or non-gastric MALT lymphoma
- 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
- - 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:
- 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 - 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
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.
Powered by
SC CTSI