Know Cancer

forgot password

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

Phase 2
18 Years
Open (Enrolling)
Diffuse Large B-Cell Lymphoma (DLBCL)

Thank you

Trial Information

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

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Response Rate (ORR)

Outcome Description:

Evaluation of the overall response rate (ORR), including Partial Response (PR) and Complete Response (CR), of subjects treated with MEDI-551 when used in combination with ICE or DHAP versus rituximab in combination with ICE or DHAP in subjects with relapsed or refractory DLBCL.

Outcome Time Frame:

Study Day 1080

Safety Issue:


Principal Investigator

Trishna Goswami, MD

Investigator Role:

Study Director

Investigator Affiliation:

MedImmune LLC


United States: Food and Drug Administration

Study ID:




Start Date:

February 2012

Completion Date:

January 2019

Related Keywords:

  • Diffuse Large B-Cell Lymphoma (DLBCL)
  • Lymphoma, Non-Hodgkin's Lymphoma, Diffuse Large B-Cell Lymphoma, DLBCL, B-Cell Malignancy, anti-CD19, monoclonal antibody, second line, ASCT, Refractory
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse



Research Site Alabaster, Alabama  
Research Site Anaheim, California  
Research Site Arlington Heights, Illinois  
Research Site Ashland, Kentucky  
Research Site Baton Rouge, Louisiana  
Research Site Baltimore, Maryland  
Research Site Alexandria, Minnesota  
Research Site Branson, Missouri  
Research Site Bismarck, North Dakota  
Research Site Akron, Ohio  
Research Site Allentown, Pennsylvania  
Research Site Clarksburg, West Virginia