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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
Open (Enrolling)
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:


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:


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:

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



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