Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

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.

Official Title

A Phase II, Single-Arm, Open-Label, Multicentre Study to Evaluate the Safety and Efficacy of Lenalidomide Combined With MOR00208 in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R-R DLBCL)

Keywords

Diffuse Large B-cell Lymphoma DLBCL CD19 monoclonal antibody MOR00208 MOR208 lenalidomide Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse

Eligibility

For people ages 18 years and up

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:
  5. relapsed and/or refractory disease
  6. at least one bidimensionally measurable, PET positive disease site (transverse diameter of ≥1.5 cm and perpendicular diameter of ≥1.0 cm at baseline)
  7. 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
  8. Eastern Cooperative Oncology Group 0 to 2
  9. Patients not considered in the opinion of the investigator eligible, or patients unwilling to undergo intensive salvage therapy including ASCT
  10. Patients must meet the following laboratory criteria at screening:
  11. absolute neutrophil count ≥1.5 × 109/L
  12. platelet count ≥90 × 109/L
  13. total serum bilirubin ≤2.5 × ULN or ≤5 × ULN in cases of Glibert's Syndrome or liver involvement by lymphoma
  14. alanine transaminase, aspartate aminotransferase and alkaline phosphatase ≤3 × ULN or <5 × ULN in cases of liver involvement
  15. serum creatinine clearance ≥60 mL/minute
  16. Females of childbearing potential (FCBP) must:
  17. not be pregnant
  18. refrain from breastfeeding and donating blood or oocytes
  19. agree to ongoing pregnancy testing
  20. commit to continued abstinence from heterosexual intercourse, or agree to use and be able to comply with the use of double-barrier contraception
  21. Males (if sexually active with a FCBP) must
  22. use an effective barrier method of contraception
  23. refrain from donating blood or sperm
  24. In the opinion of the investigator the patients must:
  25. be able and willing to receive adequate prophylaxis and/or therapy for thromboembolic events
  26. 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:
  2. other histological type of lymphoma
  3. primary refractory DLBCL
  4. a history of "double/triple hit" genetics
  5. Patients who have, within 14 days prior to Day 1 dosing:
  6. not discontinued CD20-targeted therapy, chemotherapy, radiotherapy, investigational anticancer therapy or other lymphoma specific therapy
  7. undergone major surgery or suffered from significant traumatic injury
  8. received live vaccines.
  9. required parenteral antimicrobial therapy for active, intercurrent infections
  10. Patients who:
  11. were previously treated with CD19-targeted therapy or IMiDs® (e.g. thalidomide, LEN)
  12. have undergone ASCT within the period ≤ 3 months prior to signing the informed consent form.
  13. have undergone previous allogenic stem cell transplantation
  14. 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
  15. concurrently use other anticancer or experimental treatments
  16. Prior history of malignancies other than DLBCL, unless the patient has been free of the disease for ≥5 years prior to screening.
  17. Patients with:
  18. positive hepatitis B and/or C serology.
  19. known seropositivity for or history of active viral infection with human immunodeficiency virus (HIV)
  20. CNS lymphoma involvement
  21. 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.

Locations

  • MorphoSys Research Site
    Redondo Beach California 90277 United States
  • MorphoSys Research Site
    Bakersfield California 93309 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
MorphoSys AG
ID
NCT02399085
Phase
Phase 2
Study Type
Interventional
Last Updated