A Phase 2, Multicenter, Open-label Study of MEDI-551 in Adults With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

• Status: Completed
• Trial end date: 2016-01-08
• Target enrollment: 0
• Participant gender: All

Summary

The overall purpose of the study was to determine if MEDI-551, when used in combination with salvage chemotherapy (bendamustine) in participants with relapsed or refractory CLL who are not eligible for Autologous Stem Cell Transplant (ASCT), had superior efficacy compared to rituximab in the same population.

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

Details

• Lead Sponsor: MedImmune LLC
• Treatments: Bendamustine Hydrochloride; Rituximab

Criteria

Inclusion Criteria:

• Histologically confirmed B-cell Chronic Lymphocytic Leukemia (CLL) according to the National Cancer Institute criteria; Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2; Adequate hematological function

Exclusion Criteria:

• Any chemotherapy, radiotherapy, immunotherapy, biologic, investigational, or hormonal therapy for treatment of lymphoma within 28 days prior to treatment;

• Exposure to bendamustine within the 180 days before study enrollment

• Prior autologous or allogeneic stem cell transplantation (SCT);

• Clinically significant abnormality on electrocardiogram (ECG) as determined by the treating physician or medical monitor;

• History of other invasive malignancy within 5 years except for localized/in situ carcinomas;

• Evidence of active infection, Confirmed current central nervous system involvement by leukemia or lymphoma;