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Capable of giving signed informed consent |
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Age 18 years or older (18-70 for Czech republic) |
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Histologically confirmed diagnosis of DLBCL |
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Tumor tissue for retrospective central pathology review must be provided as an adjunct to participation in this study |
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Patients must have |
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relapsed and/or refractory disease |
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at least one bidimensionally measurable, PET positive disease site (transverse diameter of ≥1.5 cm and perpendicular diameter of ≥1.0 cm at baseline) |
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received at least one, but no more than three previous systemic regimens for the treatment of DLBCL and one therapy line must have included a CD20-targeted therapy |
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Eastern Cooperative Oncology Group 0 to 2 |
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Patients not considered in the opinion of the investigator eligible to undergo |
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intensive salvage therapy including ASCT |
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Patients must meet the following laboratory criteria at screening |
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absolute neutrophil count ≥1.5 × 10^9/L |
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platelet count ≥90 × 10^9/L |
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total serum bilirubin ≤2.5 × ULN or ≤5 × ULN in cases of Glibert's Syndrome or liver involvement by lymphoma |
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alanine transaminase, aspartate aminotransferase and alkaline phosphatase ≤3 × ULN or <5 × ULN in cases of liver involvement |
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serum creatinine clearance ≥ 60 mL/minute |
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Patients who received previous CD19 targeted therapy (other than tafasitamab) must |
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have CD19 positive lymphoma confirmed on a biopsy taken since completing the |
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prior CD19 targeted therapy |
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Patients with primary refractory disease who received at least one, but no more than three previous systemic regimens (including a CD20 targeted therapy) |
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Patients who are legally institutionalized or concurrent enrollment in another interventional clinical study
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Patients who have
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other histological type of lymphoma
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a history of "double/triple hit" genetics
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Patients who have, within 14 days prior to Day 1 dosing
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not discontinued CD20-targeted therapy, chemotherapy, radiotherapy, investigational anticancer therapy or other lymphoma specific therapy
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undergone major surgery (with 4 weeks) or suffered from significant traumatic injury
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received live vaccines (within 4 weeks)
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required parenteral antimicrobial therapy for active, intercurrent infections
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Patients who
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have not recovered sufficiently from the adverse toxic effects of prior therapies
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have history of hyper sensitivity to compounds of similar biological or chemical composition to tafasitamab IMiDs® and/or the excipients contained in the study treatment formulations
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have undergone ASCT within the period ≤ 3 months prior to signing the informed consent form
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were previously treated with IMiDs® (e.g. thalidomide, LEN)
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have undergone previous allogenic stem cell transplantation
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have a history of deep venous thrombosis/embolism and who are not willing/able to take venous thromboembolic event prophylaxis during the entire treatment period
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concurrently use other anticancer or experimental treatments
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History of other malignancy that could affect compliance with the protocol or
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interpretation of results. Exceptions
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Patients with any malignancy appropriately treated with curative intent and the malignancy has been in remission without treatment for >2 years prior to enrollment are eligible
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Patients with low-grade, early-stage prostate cancer (Gleason score 6 or below, Stage 1 or 2) with no requirement for therapy at any time prior to study are eligible
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Patients with
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positive hepatitis B and/or C serology
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known seropositivity for or history of active viral infection with human immunodeficiency virus (HIV)
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CNS lymphoma involvement
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history or evidence of clinically significant cardiovascular, CNS and/or other systemic disease that would in the investigator's opinion preclude participation in the study or compromise the patient's ability to give informed consent
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history or evidence of rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
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gastrointestinal (GI) abnormalities (issue with absorption) including the inability to take oral medication
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history or evidence of severe hepatic impairment (total serum bilirubin > 3mg/dL), jaundice unless secondary to Gilbert's syndrome or documented liver involvement by lymphoma
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history of hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical class
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any other medical condition which, in the investigator's opinion, makes the patient unsuitable for the study
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Female participants: Agreement to remain abstinent (refrain from heterosexual
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intercourse) or use contraceptive methods and refrain from breast feeding and
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donating eggs; agreement to ongoing pregnancy testing during the course of the
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study, and after study therapy has ended Male participants: agreement to
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remain abstinent (refrain from heterosexual intercourse) or use a condom and
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agreement to refrain from donating sperm
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