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

• Status: Completed
• Trial end date: 2016-07-11
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: MedImmune LLC
• Treatments: Rituximab

Criteria

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