Clinical trial NCT02399085 (phase 2, status: active, not recruiting)
Conditions: diffuse large b-cell lymphoma
ICD codes: S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S
Drugs: mor00208, lenalidomide
SMILES: NC1=CC=CC2=C1CN(C1CCC(=O)NC1=O)C2=O
Eligibility criteria:

        Major Inclusion Criteria:

          1. Age >18 years

          2. Histologically confirmed diagnosis of DLBCL

          3. Tumour tissue for central pathology review and correlative studies must be provided.

          4. 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

          5. Patients not considered in the opinion of the investigator eligible, or patients
             unwilling to undergo intensive salvage therapy including ASCT

          6. Patients must meet the following laboratory criteria at screening:

               -  absolute neutrophil count ≥1.5 × 109/L

               -  platelet count ≥90 × 109/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

          7. Females of childbearing potential (FCBP) must:

               -  not be pregnant

               -  refrain from breastfeeding and donating blood or oocytes

               -  agree to ongoing pregnancy testing

               -  commit to continued abstinence from heterosexual intercourse, or agree to use and
                  be able to comply with the use of double-barrier contraception

          8. Males (if sexually active with a FCBP) must

               -  use an effective barrier method of contraception

               -  refrain from donating blood or sperm

          9. In the opinion of the investigator the patients must:

               -  be able and willing to receive adequate prophylaxis and/or therapy for
                  thromboembolic events

               -  be able to understand the reason for complying with the special conditions of the
                  pregnancy prevention risk management plan and give written acknowledgement of
                  this.

        Major Exclusion Criteria:

          1. Patients who have:

               -  other histological type of lymphoma

               -  primary refractory DLBCL

               -  a history of "double/triple hit" genetics

          2. 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 or suffered from significant traumatic injury

               -  received live vaccines.

               -  required parenteral antimicrobial therapy for active, intercurrent infections

          3. Patients who:

               -  were previously treated with CD19-targeted therapy or IMiDs® (e.g. thalidomide,
                  LEN)

               -  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

          4. Prior history of malignancies other than DLBCL, unless the patient has been free of
             the disease for ≥5 years prior to screening.

          5. 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.