Brentuximab Vedotin plus Lenalidomid und Rituximab zur Behandlung von Patienten mit rezidiviertem oder refraktärem diffusem grosszelligem B-Zell-Lymphom (DLBCL)

Drug: Brentuximab vedotin;Drug: Rituximab;Drug: Lenalidomide;Other: Placebo

Gender: All
Maximum age: N/A
Minimum age: 18 Years

Inclusion Criteria:

- Participants with relapsed or refractory diffuse and transformed large B-cell lymphoma
(R/R DLBCL). DLBCL and cell of origin (GCB versus non-GCB) will be histologically
determined by local pathology assessment for the purposes of study eligibility and
stratification.

- Participants must have R/R disease following 2 or more lines of prior systemic
therapy.

- For participants with transformed DLBCL, at least the last systemic therapy used
must have been for DLBCL

- Participants must be HSCT or CAR-T ineligible according to the investigator and must
meet at least one of the following criteria:

1. One or more co-morbidities, including cardiac, pulmonary, renal or hepatic
dysfunction that in the opinion of the Investigator make the participant
medically unfit to received HSCT or CAR-T therapy

2. Active disease following induction and salvage chemotherapy

3. Inadequate stem cell mobilization (for HSCT)

4. Relapse following prior HSCT or CAR-T

5. Unable to receive CAR-T therapy due to financial, geographic, insurance, or
manufacturing issues

- Participants must have tumor tissue submitted to the central pathology lab. The tumor
tissue submitted should be from the most recent biopsy that contains DLBCL.

- An Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2

- Participants must have fluorodeoxyglucose (FDG)-avid disease by positron emission
tomography (PET) and bidimensional measurable disease of at least 1.5 cm by computed
tomography (CT), as assessed by the site radiologist within 28 days of Day 1.

Exclusion Criteria:

- History of another malignancy within 2 years before the first dose of study drug or
any evidence of residual disease from a previously diagnosed malignancy

- History of progressive multifocal leukoencephalopathy (PML)

- Active cerebral/meningeal disease related to the underlying malignancy. Participants
with a history of cerebral/meningeal disease related to the underlying malignancy are
allowed if prior CNS disease has been effectively treated and without progression for
at least 3 months.

- Any uncontrolled Grade 3 or higher (per NCI CTCAE version 5.0) viral, bacterial, or
fungal infection within 2 weeks prior to the first dose of study drug. Routine
antimicrobial prophylaxis is permitted

- Chemotherapy, radiotherapy, biologics, and/or other antitumor treatment with
immunotherapy that is not completed 3 weeks prior to first dose of study drug, unless
underlying disease has progressed on treatment

- Previous treatment with brentuximab vedotin or lenalidomide.

- Previous treatment with other vedotin-based ADCs is permitted if the last dose is
at least 6 months prior to Day 1.

- Current therapy with immunosuppressive medications (including steroids), other
systemic anti-neoplastic, or investigational agents

a) Prednisone (or equivalent) =10 mg/day may be used for non-lymphomatous purposes

- Documented history of a cerebral vascular event (stroke or transient ischemic attack),
unstable angina, myocardial infarction, or cardiac symptoms consistent with New York
Heart Association (NYHA) Class III-IV within 6 months prior to the first dose of study
drugs

- Congestive heart failure, Class III or IV, by the NYHA criteria

- Grade 2 or higher peripheral sensory or motor neuropathy at baseline