Status:
ACTIVE_NOT_RECRUITING
Safety and Pharmacokinetics Study of a Modified Tafasitamab IV Dosing Regimen Combined With Lenalidomide in R-R DLBCL Patients
Lead Sponsor:
Incyte Corporation
Conditions:
Diffuse Large B Cell Lymphoma
Eligibility:
All Genders
18-99 years
Phase:
PHASE1
PHASE2
Brief Summary
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 Refracto...
Eligibility Criteria
Inclusion
- Major
- 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:
- relapsed and/or refractory disease
- at least one bidimensionally measurable, PET positive disease site (transverse diameter of ≥1.5 cm and perpendicular diameter of ≥1.0 cm at baseline)
- 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
- Eastern Cooperative Oncology Group 0 to 2
- 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:
- absolute neutrophil count ≥1.5 × 10\^9/L
- platelet count ≥90 × 10\^9/L
- total serum bilirubin ≤2.5 × ULN or ≤5 × ULN in cases of Glibert's Syndrome or liver involvement by lymphoma
- alanine transaminase, aspartate aminotransferase and alkaline phosphatase ≤3 × ULN or \<5 × ULN in cases of liver involvement
- serum creatinine clearance ≥ 60 mL/minute
- 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
- Patients who are legally institutionalized or concurrent enrollment in another interventional clinical study
- Patients who have:
- other histological type of lymphoma
- a history of "double/triple hit" genetics
- Patients who have, within 14 days prior to Day 1 dosing:
- not discontinued CD20-targeted therapy, chemotherapy, radiotherapy, investigational anticancer therapy or other lymphoma specific therapy
- undergone major surgery (with 4 weeks) or suffered from significant traumatic injury
- received live vaccines (within 4 weeks).
- required parenteral antimicrobial therapy for active, intercurrent infections
- Patients who:
- have not recovered sufficiently from the adverse toxic effects of prior therapies
- were previously treated with IMiDs® (e.g. thalidomide, LEN)
- 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
- have undergone ASCT within the period ≤ 3 months prior to signing the informed consent form.
- have undergone previous allogenic stem cell transplantation
- 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
- concurrently use other anticancer or experimental treatments
- History of other malignancy that could affect compliance with the protocol or interpretation of results. Exceptions
- 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
- 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
- Patients with:
- positive hepatitis B and/or C serology.
- known seropositivity for or history of active viral infection with human immunodeficiency virus (HIV)
- CNS lymphoma involvement
- 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
- history or evidence of rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
- gastrointestinal (GI) abnormalities (issue with absorption) including the inability to take oral medication
- 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
- history of hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical class
- any other medical condition which, in the investigator's opinion, makes the patient unsuitable for the study
- 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
Key Trial Info
Start Date :
July 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2027
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT05222555
Start Date
July 19 2022
End Date
November 30 2027
Last Update
July 28 2025
Active Locations (62)
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1
Morristown Memorial Hospital
Morristown, New Jersey, United States, 07960-6459
2
Texas Oncology-Baylor Charles A. Sammons Cancer Center - USOR
Dallas, Texas, United States, 75246-2092
3
Vista Oncology
Olympia, Washington, United States, 98506
4
UK St. Pölten
Sankt Pölten, Lower Austria, Austria, 3100