Open Label Study to Evaluate the Safety and Efficacy of Lenalidomide With MOR00208 in Patients With R-R DLBCL

Major Inclusion Criteria:

• Age >18 years
• Histologically confirmed diagnosis of DLBCL
• Tumour tissue for central pathology review and correlative studies had to be provided.
• Participants must had:
• 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 had included a CD20-targeted therapy
• Eastern Cooperative Oncology Group 0 to 2
• Participants were not considered in the opinion of the investigator eligible, or participants unwilling to undergo intensive salvage therapy including ASCT
• Participants had to 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
• Females of childbearing potential (FCBP) must:
• not be pregnant
• refrain from breastfeeding and donating blood or oocytes
• agreed to ongoing pregnancy testing
• committed to continued abstinence from heterosexual intercourse, or agree to use and be able to comply with the use of double-barrier contraception
• Males (if sexually active with a FCBP) had to
• use an effective barrier method of contraception
• refrain from donating blood or sperm
• In the opinion of the investigator the participants had to:
• be able and willing to receive adequate prophylaxis and/or therapy for thromboembolic events
• be able to understand, give written informed consent and comply with all study-related procedures, medication use, and evaluations
• had no history of noncompliance in relation to medical regimens or not be considered potentially unreliable and/or uncooperative
• be able to understand the reason for complying with the special conditions of the pregnancy prevention risk management plan and gave written acknowledgement of this.

Major Exclusion Criteria:

• Participants who had:
• other histological type of lymphoma
• primary refractory DLBCL
• a history of "double/triple hit" genetics
• Participants who had, within 14 days prior to Day 1 dosing:
• not discontinued CD20-targeted therapy, chemotherapy, radiotherapy, investigational anticancer therapy or other lymphoma specific therapy
• underwent major surgery or suffered from significant traumatic injury
• received live vaccines.
• required parenteral antimicrobial therapy for active, intercurrent infections
• Participants who:
• had, in the opinion of the investigator, not recovered sufficiently from the adverse toxic effects of prior therapies
• were previously treated with CD19-targeted therapy or immunomodulatory drugs (IMiDs)® (e.g., thalidomide, LEN)
• had a history of hypersensitivity to compounds of similar biological or chemical composition to MOR00208, IMiDs® and/or the excipients contained in the study drug formulations
• had undergone ASCT within the period ≤ 3 months prior to the signing of the Informed Consent Form. Patients who had a more distant history of ASCT had to exhibit full haematological recovery before enrolment into the study
• had undergone previous allogenic stem cell transplantation
• had a history of deep venous thrombosis/embolism, threatening thromboembolism or known thrombophilia or were at a high risk for a thromboembolic event in the opinion of the investigator and who were not willing/able to take venous thromboembolic event prophylaxis during the entire treatment period
• concurrently used other anti-cancer or experimental treatments
• Prior history of malignancies other than DLBCL, unless the participant had been free of the disease for ≥5 years prior to scr