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

Overview

  • Study type

    Interventional
  • Study phase

    II
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 12-003829
    NCT ID: NCT01453205
    Sponsor Protocol Number: CD-ON-MEDI-551-1088

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. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

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 us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

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

Closed for enrollment

Contact information:

Research Information Center

800-664-4542

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CLS-20115540

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