Safety and Pharmacokinetics Study of a Modified Tafasitamab IV Dosing Regimen Combined With Lenalidomide in R-R DLBCL Patients (MINDway)

  • End date
    Feb 28, 2027
  • participants needed
  • sponsor
    MorphoSys AG
Updated on 9 April 2023


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.

Condition Diffuse Large B Cell Lymphoma
Treatment Lenalidomide, Tafasitamab
Clinical Study IdentifierNCT05222555
SponsorMorphoSys AG
Last Modified on9 April 2023


Yes No Not Sure

Inclusion Criteria

Capable of giving signed informed consent
Age 18 years or older (18-70 for Czech republic)
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)

Exclusion Criteria

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
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
were previously treated with IMiDs® (e.g. thalidomide, LEN)
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
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