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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 156

Inclusion Criteria

• Previous confirmation of B-cell CLL (including SLL) with a characteristic immunophenotype by flow cytometry.
• Progressive disease after receiving at least one prior line of treatment (a minimum of one course of chemotherapy with rituximab) and not a candidate for HSC or BM transplant
• Deemed a candidate for bendamustine/rituximab therapy by their treating physician
• Presence of symptomatic disease
• Adequate hematological function
• Adequate organ function
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 130
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 26

Exclusion Criteria

• Any chemotherapy, radiotherapy, immunotherapy, biologic, investigational or hormonal therapy for treatment of lymphoma within 28 days prior to treatment
• Exposure to Bendamustine within 180 days before drug administration
• Any active secondary malignancy
• Prior autologous or allogeneic stem cell transplantation SCT
• 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 or basal/squamous skin cancer.
• Evidence of active infection
• Documented current central nervous system involvement by leukemia or lymphoma
• Having Richter’s transformation or high-grade disease
• Current pregnancy or lactation
• History of yellow fever vaccination within three months prior to study enrollment

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The overall purpose of the study is to determine if MEDI-551, when used in combination with salvage chemotherapy (bendamustine) in patients with relapsed or refractory CLL (or SLL) who have progressed after one prior treatment with retuximab, has superior efficacy compared to rituximab in the same population.;Secondary Objective: To assess the safety and tolerability, antitumor activity, overall survival, pharmakokinectics and immunogenicitiy of MEDI-551 when used in combination with Bendamustine;Primary end point(s): Evaluation of the Overall Response Rate (ORR), including Complete Response (CR) and Partial Response (PR), in adult subjects with progressive CLL (or SLL) treated with up to 6 cycles of MEDI-551 in combination with bendamustine versus rituximab in combination with bendamustine.;Timepoint(s) of evaluation of this end point: Day 720

Secondary Outcome Measures

Name	Time	Method

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