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

• Status: Active, not recruiting
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, multicentre study to characterize the safety and efficacy of the human anti CD19 antibody MOR00208 in combination with Lenalidomide in adult subjects with relapsed/refractory Diffuse Large B-cell Lymphoma (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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MorphoSys AG
• Treatments: Lenalidomide; Thalidomide

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.