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)
- Conditions
- Relapsed or refractory chronic lymphocytic leukemia (CLL)MedDRA version: 14.1Level: LLTClassification code 10008976Term: Chronic lymphocytic leukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-002566-21-IT
- Lead Sponsor
- MEDIMMUNE ONCOLOGY INC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 156
•Histologically confirmed aggressive B-cell Chromic Lymphocytic Leukemia( CLL) according to the National Cancer Institute criteria •Adequate hematological function
Are the trial subjects under 18? no
Number of subjects for this age range: 0
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
• Any chemotherapy, radiotherapy, immunotherapy, biologic, investigational or hormonal therapy for treatment of lymphoma within 42 days prior to treatment • Exposure to Bendamustine within 180 days before study enrollment • 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
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 who are not eligible for Autologous Stem Cell Transplant (ASCT), has superior efficacy compared to rituximab in the same population.;Secondary Objective: To assess the safety and tolerability, antitumor activity, overall survival, pharmakokinectics and immunogenicity 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 relapsed or refractory CLL 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