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A Phase 2 Open-label Study of MEDI-551 and Bendamustine vs Rituximab and Bendamustine in Adults With Relapsed or Refractory CLL


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Chronic Lymphocytic Leukemia (CLL)

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Trial Information

A Phase 2 Open-label Study of MEDI-551 and Bendamustine vs Rituximab and Bendamustine in Adults With Relapsed or Refractory CLL


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 42 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 such as cervical carcinoma in situ or basal/squamous skin cancer;

- Evidence of active infection, Confirmed 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 Complete Response (CR) and Partial Response (PR), in adult subjects with relapsed or refractory CLL treated with up to 6 cycles of MEDI-551 in combination with bendamustine versus rituximab in combination with bendamustine.

Outcome Time Frame:

Study Day 720

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-551-1019

NCT ID:

NCT01466153

Start Date:

February 2012

Completion Date:

December 2015

Related Keywords:

  • Chronic Lymphocytic Leukemia (CLL)
  • Chronic lymphocytic leukemia; leukemia; B-Cell malignancy; anti-CD19; monoclonal antibody; CLL; Refractory; Relapse; Non-Hodgkin's Lymphoma
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

Name

Location
Research Site Alabaster, Alabama  
Research Site Anaheim, California  
Research Site Boulder, Colorado  
Research Site Boca Raton, Florida  
Research Site Arlington Heights, Illinois  
Research Site Bloomington, Indiana  
Research Site Ashland, Kentucky  
Research Site Baton Rouge, Louisiana  
Research Site Baltimore, Maryland  
Research Site Battle Kreek, Michigan  
Research Site Branson, Missouri  
Research Site Asheville, North Carolina  
Research Site Bismarck, North Dakota  
Research Site Akron, Ohio  
Research Site Allentown, Pennsylvania  
Research Site Aberdeen, South Dakota  
Research Site Abilene, Texas  
Research Site Clarksburg, West Virginia