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
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 99
Updated:4/17/2018
Start Date:February 27, 2012
End Date:July 11, 2016

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A Phase 2 Randomized Open-label Study of MEDI-551 in Adults With Relapsed or Refractory DLBCL

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.


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
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