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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Diffuse Large B-Cell Lymphoma (DLBCL)

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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
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

Type of Study:

Interventional

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:

No

Principal Investigator

Trishna Goswami, MD

Investigator Role:

Study Director

Investigator Affiliation:

MedImmune LLC

Authority:

United States: Food and Drug Administration

Study ID:

CD-ON-MEDI-551-1088

NCT ID:

NCT01453205

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

Name

Location

Research SiteAlabaster, Alabama  
Research SiteAnaheim, California  
Research SiteArlington Heights, Illinois  
Research SiteAshland, Kentucky  
Research SiteBaton Rouge, Louisiana  
Research SiteBaltimore, Maryland  
Research SiteAlexandria, Minnesota  
Research SiteBranson, Missouri  
Research SiteBismarck, North Dakota  
Research SiteAkron, Ohio  
Research SiteAllentown, Pennsylvania  
Research SiteClarksburg, West Virginia