A Phase 2, Multicenter, Randomized, Open-label Study of MEDI-551 in Adults with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Overview

About this study

The overall purpose of the study is to determine if MEDI-551, when used in combination with salvage chemotherapy, Ifosfamide-carboplatin-etoposide (ICE) or Dexamethasone-cytarabine (DHAP) in patients with relapsed or refractory DLBCL who are eligible for Autologous Stem Cell Transplant (ASCT), has superior efficacy compared to rituximab in the same population.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Study closed to enrollment

Inclusion Criteria:

  • Histologically confirmed aggressive B-cell DLBCL, including FL transforming to DLBCL & Grade III FL
  • Relapsed from or refractory to at least one treatment containing rituximab or another anti-CD20 based immunotherapy combined with anthracycline- or anthracenedione-based chemotherapy
  • Eligible for ASCT
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  • Life expectancy of ≥ 12 weeks
  • Adequate hematological function

Exclusion Criteria:

  • Any chemotherapy, radiotherapy, immunotherapy, biologic, investigational or hormonal therapy for treatment of lymphoma within 28 days prior to treatment
  • Previous cancer therapy for DLBCL other than anthracycline- or anthracenedione based chemoimmunotherapy, monotherapy rituximab prior to first line therapy and/or as a maintenance therapy, or limited field radiotherapy
  • Prior autologous or allogeneic SCT
  • New York Heart Association ≥ Class II congestive heart failure; Clinically significant abnormality on ECG
  • History of other invasive malignancy within 5 years except for localized/in situ, carcinomas such as cervical carcinoma in situ.
  • Evidence of active infection
  • Documented current central nervous system involvement by leukemia or lymphoma

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Patrick Johnston, M.D., Ph.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

Publications are currently not available
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CLS-20115540

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