Nasz Lekarz Osrodek Badan Klinicznych | Torun, Poland
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This is an open-label, multicentre study too Evaluate the Safety and Pharmacokinetics of a Modified Tafasitamab IV Dosing Regimen Combined with Lenalidomide (LEN) in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL) who have had at least one, but no more than three prior systemic regimens and who are not eligible for high dose chemotherapy (HDC) with autologous stem-cell transplantation (ASCT) at the time of study entry.
Enrollment
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Inclusion and exclusion criteria
Major Inclusion Criteria:
Capable of giving signed informed consent
Age 18 years or older
Histologically confirmed diagnosis of DLBCL
Tumor tissue for retrospective central pathology review must be provided as an adjunct to participation in this study.
Patients must have:
Patients not considered in the opinion of the investigator eligible to undergo intensive salvage therapy including ASCT
Patients must meet the following laboratory criteria at screening:
Patients who received previous CD19 targeted therapy (other than tafasitamab) must have CD19 positive lymphoma confirmed on a biopsy taken since completing the prior CD19 targeted therapy
Patients with primary refractory disease who received at least one, but no more than three previous systemic regimens (including a CD20 targeted therapy)
Major Exclusion Criteria:
Patients who are legally institutionalized or concurrent enrollment in another interventional clinical study
Patients who have:
Patients who have, within 14 days prior to Day 1 dosing:
Patients who:
History of other malignancy that could affect compliance with the protocol or interpretation of results. Exceptions
Patients with:
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
Primary purpose
Allocation
Interventional model
Masking
53 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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